Pfizer

Flu-like symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2021-01-01 headache, sweating Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling h... Read more
Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold
60 2021-01-01 chills, headache, malaise Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night ... Read more
Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night 12/31 symptoms worsened with above & headache
60 2021-01-03 chills, headache * Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, ... Read more
* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight
60 2021-01-03 chills, fatigue, headache 12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. ... Read more
12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.
60 2021-01-03 fatigue, headache Debilitating frontal headache, accompanied by nausea and vomiting, and fatigue for 16 hours
60 2021-01-03 influenza like illness, sweating Flu-like symptoms - nausea, sweat. Arm sore immediately after injection - sore for 2 days.
60 2021-01-04 fatigue, headache Fatigue on Friday 1/1/21 (2 naps resolved fatigue on 1/1/21) and daily napping resolve fatigue 1/2/2... Read more
Fatigue on Friday 1/1/21 (2 naps resolved fatigue on 1/1/21) and daily napping resolve fatigue 1/2/21-1/4/21 Headache on Saturday, 1/2/21. Took nap to resolve Blurry vision Sunday when reading began on 1/3/21 and has not resolved as of 1/5/21. Pain behind left eye on morning of 1/5/21
60 2021-01-04 throat irritation Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising... Read more
Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising noted. Ice applied and patient monitored for over 30 minutes. Patient did complain of scratchy throat while being monitored, but refused Benadryl at this time. Patient will notify her physician of this reaction to the vaccine.
60 2021-01-04 throat pain Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation... Read more
Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
60 2021-01-04 fever, chills Received the first dose of vaccine, no problems for 12 hours, then I started to have non-stop shiver... Read more
Received the first dose of vaccine, no problems for 12 hours, then I started to have non-stop shivering and fevers for almost 18 hours then felt better.
60 2021-01-04 chills, fever, runny nose Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a... Read more
Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.
60 2021-01-04 cough, chills Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm c... Read more
Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.
60 2021-01-04 headache, sleepiness, chills Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have ch... Read more
Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have chills and excessives sleepiness for 48 hours.
60 2021-01-04 chills, sleepiness, fever, malaise, fatigue generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run do... Read more
generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
60 2021-01-04 headache nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contacta... Read more
nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2; reported as COVID19 Vaccine; lot number: EJ1685; expiration date: Mar2021), via an unspecified route of administration right arm on 18Dec2020 15:00 at single dose for Covid-19 vaccination. Medical history included IBS (irritable bowel syndrome), hysterectomy at age 42 and she doesn't have periods (amenorrhea). The patient family medical history included her family are all dead and has been for a long time. The patient's concomitant medications were not reported. It was reported that vaccinations within 4 weeks included shingles vaccination 5 weeks before covid-19 vaccine wherein the patient first singles shot was fine. Her second shingles shot made her sick, body aches, and fever for about 24 hours. She received it from a pharmacy inside a store. The reporter mentioned that she took her first covid vaccine shot and was able to experience nausea, headache lower abdominal pain. She inquired if there was information on until when she will be experiencing this or how long the symptoms will last. She mentioned that she had headaches and waves of nausea, and before nausea, she had lower abdominal pain. She doesn't know if abdominal pain was coincidental. She had a hysterectomy, so she doesn't have periods. She lives with IBS, but this abdominal pain was different. Immediately after COVID-19 Vaccine within about 20 minutes after injection (18Dec2020 15:20), she had headaches and she still has been having headaches. She had strange lower abdominal pain that lasted a minute and a half then shortly after that started having waves of nausea. She added that the waves of nausea began 24 hours after the COVID-19 Vaccine (19Dec2020 15:00). The outcome of the event headache was not recovered, as for nausea was unknown while the outcome of the other event was recovered on Dec2020.
60 2021-01-04 throat irritation, fatigue, chills tired Chills Muscle aches Throat irritation weakness no energy hot flashes
60 2021-01-05 chills, fatigue, malaise 19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Clust... Read more
19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses "spacey" with fatigue
60 2021-01-05 headache, fatigue, fever Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscl... Read more
Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20
60 2021-01-05 body temperature increased, chills, headache, influenza like illness, malaise Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in b... Read more
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
60 2021-01-05 fever I have had a fever ranging from 100.1 to 100.5 since 7 pm on the day I received the 2nd dose vaccine... Read more
I have had a fever ranging from 100.1 to 100.5 since 7 pm on the day I received the 2nd dose vaccine on 1/4/2021. Symptoms include extreme body aches, joint aches, and headache. Today is 1/6/2021 my temp at 7:30 am was 100.3. I have had to miss work yesterday and today so far.
60 2021-01-05 malaise, headache, fatigue, chills INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINES... Read more
INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.
60 2021-01-05 headache Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nu... Read more
Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (Batch/lot number: EK5730) intramuscular at Left arm, on 31Dec2020 at single dose for covid-19 immunisation. Medical history included mild Hypertension (HTN), Hypothyroidism, Anxiety, Gastrooesophageal reflux disease (GERD), Hyperlipidemia. Known allergies included Shellfish, SSRI, Demerol, Codeine. The patient did not have covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication included lisinopril, levothyroxine, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), bupropion hydrochloride (WELLBUTRIN), atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), vitamin c [ascorbic acid], calcium, linum usitatissimum seed oil (FLAX SEED OIL), glucosamine, curcuma longa (TURMERIC), ubidecarenone (COQ 10), collagen. The patient experienced itching but no hives, slight headache, dizziness on 31Dec2020 15:30. The patient received Benadryl 25mg for the events. The patient did not have covid tested post vaccination. The outcome of events was recovering.
60 2021-01-05 cough Pfizer BioNTech COVID-19 Vaccine EUA Patient given vaccine and nurse used CDC screening check list.... Read more
Pfizer BioNTech COVID-19 Vaccine EUA Patient given vaccine and nurse used CDC screening check list. Patient's noted yes to allergies made nurse talk to lead nurse regarding allergies. Plan of care was to vaccinate but have patient stay at least 20 minutes. During the 20 minute wait, the observer was notified by patient she was having some throat tickling and tightening. Observer notified lead nurse. Lead nurse approached patient and had her move from waiting area back into her nurses room. Patient complained of throat tickling and tightening but stated she was fine. Nurses noted increasing coughing. Pulse ox and respirations checked. Patient continued to state she was fine and was not in physical distress. Nursing director was called and nurses advised to give epi and follow protocol. Epi given in left thigh. Patient vitals monitored and patient was able to tell throat started to loosen and coughing stopped. 911 called but patient refused transport after EMS assessed patient. Nursing Director discussed patient incident with Medical Director and nurses were advised to administer a IM dose of benadryl. Patient agreed and verbalized understanding her risks of not going to ER for monitoring. Patient signed refusal for treatment form and planned to call her doctor when she left. Patient vitals were stable and patient left clinic on her own accord around 11:00 am.
60 2021-01-05 body temperature increased, sneezing, runny nose Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse Al... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021   Date: 1/6/2021 MRN: 3274958   Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020   PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours.     ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness       Objective   Vitals Vitals:   01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 °F (37.3 °C) SpO2: 100% BS 94 at 12:38   Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm     APRN Electronically Signed 1/6/2021 12:45 PM    
60 2021-01-05 headache Tingling of toes and finger on the on side of body vaccine occurred, light headed, HEAD ACHE
60 2021-01-05 fever dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to... Read more
dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
60 2021-01-06 fever, chills, headache 1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting. - 10:06... Read more
1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting. - 10:06 pm, chills, headache, fever 99.6 - 10:38 pm, chills headache, fever 100.1 - 11:05pm, chills headache, fever 101.5 -
60 2021-01-06 fatigue, fever 12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went awa... Read more
12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went away over night, the rest of the symptoms stayed through the day.
60 2021-01-06 chills 30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some a... Read more
30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.
60 2021-01-06 headache, fatigue, fever APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXT... Read more
APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXTREME FATIGUE AND HEADACHE ADN THE INJECTION SITE WAS PAINFUL. I HAD THE COVID VIRUS DIAGNOSED 10/23/2020 WITH THE EXACT SAME SYMPTOMS EXCEPT I RAN A HIGHER TEMP
60 2021-01-06 fever, chills Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self ... Read more
Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self medicated with Motrin with some improvement of symptoms.
60 2021-01-06 fatigue, headache Extreme fatigue, muscle aches ,joint pain. Have slight headache.
60 2021-01-06 headache, fatigue, headache, fatigue Fatigue, body aches, headache x 1 day now resolved.
60 2021-01-06 fatigue, headache Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. wit... Read more
Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.
60 2021-01-06 chills, cough, fever Severe Body aches cough fever 100.8 chills diarrhea
60 2021-01-07 sweating, chills Chest pain Abdominal pain Fever, severe chills, diaphoresis Seizure like activity for two night
60 2021-01-07 headache Diarrhea Headache Narrative:
60 2021-01-07 fever, headache Headache & Fever
60 2021-01-07 chills, fatigue chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, o... Read more
chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, on right arm, under left foot; This is a spontaneous report from a contactable nurse (patient). A 60-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via intramuscular route of administration in the right arm on 28Dec2020 at 05:30 AM (at the age of 60 years-old) as a single dose for COVID-19 vaccination. Medical history included diabetic and asthma. The patient's allergies included sulfa, iodine, shellfish and latex/rubber. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020 at 06:30 AM, the patient experienced chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The report was reported as non-serious. The patient was not treated for chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The clinical outcome of chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
60 2021-01-07 sweating, malaise very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt real... Read more
very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.
60 2021-01-08 fatigue, fever, chills, sweating, malaise 17 hours after vaccine, developed gradually worsening fatigue, myalgias, arthralgias, chills, sweats... Read more
17 hours after vaccine, developed gradually worsening fatigue, myalgias, arthralgias, chills, sweats, malaise, and fever up to 103. Sxs peaked at approx 24 hrs post vaccine administration, resolving nearly completely by the following morning. Would have reported via v-safe but had no info to access the app.
60 2021-01-08 chills, fatigue Arthralgia chills, swollen glands, fatigue x 2 days;
60 2021-01-08 headache Headache
60 2021-01-08 fatigue, headache Headache very fatigue, soreness at injection site Narrative: stayed home from work
60 2021-01-08 fever, headache, fatigue Severe fatigue, headache, joint pain, fever. Started around 0700 next day of injection and these sym... Read more
Severe fatigue, headache, joint pain, fever. Started around 0700 next day of injection and these symptoms lasted 24 hours. Took Tylenol, Ibuprofen for fever. Even with these two onboard, continued low grade temp.
60 2021-01-08 head discomfort c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Di... Read more
c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Diphenhydramine HCL VS 178/85, 72, 18, 98% O2sat. at 1340 states she felt better.
60 2021-01-09 chills Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improve... Read more
Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.
60 2021-01-09 headache HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35... Read more
HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35 PM B/P 185/98 PR 60 @11:45 NO N/V NO CHEAT PAIN
60 2021-01-10 malaise, headache 1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to t... Read more
1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading
60 2021-01-10 cough, fever COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th ... Read more
COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.
60 2021-01-10 fever, chills Fever 102.2, chills, body aches, nausea.
60 2021-01-10 fever, headache, fatigue, chills Had shot at 11am on Fri. 1/8. Woke up at 230 am Sat. morning 1/9 with chills, fever 101, aches, head... Read more
Had shot at 11am on Fri. 1/8. Woke up at 230 am Sat. morning 1/9 with chills, fever 101, aches, headache and fatigue. Started to feel better later in the day, but still had fever 100, bad headache and very fatigued. Still had fever at bedtime at 830 of 100.2. Woke up at 430 am for work on Sunday 1/10 feeling better and no fever. I was still somewhat tired but that was it. Nothing since this writing.
60 2021-01-10 sweating Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms... Read more
Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms get better.
60 2021-01-10 headache, throat pain Injection site slightly sore to the touch, very slight sore throat and very slight headache
60 2021-01-10 headache, fatigue, head discomfort Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache... Read more
Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
60 2021-01-10 headache, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and expe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and experienced a headache. The next day at 2:15pm the patient reported a temperature of 99.0 degrees Fahrenheit, not being as tired, but starting at 9:30 am that morning experiencing "tongue being tied" and having difficulty communicating described as "know what they want to say but it... doesn't come out" that lasted three hours. The patient denied problems walking or being confused. The patient was immediately referred to the emergency department for evaluation. Upon arrival to the emergency department patient had clear speech speaking in complete sentences and ambulating independently with a steady gait. Physical and neurological exams both normal: no aphasia and no focal neurological deficits, normal strength and sensation throughout. Initial vital signs within normal ranges except blood pressure 149/88 mmHg. Patient remained asymptomatic and stable throughout emergency department stay. Repeat vital signs were within normal ranges and patient was discharged to home with a diagnosis of transient ischemic attack. On follow-up visit with primary care physician four days after vaccination patient reports feeling much better and no new symptoms reported.
60 2021-01-10 headache, sweating She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion ... Read more
She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F
60 2021-01-10 fever, chills, headache Woke up morning after 2nd dose of COVID-19 vaccine with noticeable left armpit swelling (noticed whi... Read more
Woke up morning after 2nd dose of COVID-19 vaccine with noticeable left armpit swelling (noticed while applying my deodorant for the day). Swelling was the size of large lemon. Smaller amount of swelling noticed in right armpit, also. Vaccinations had both been done in my LEFT arm and greater swelling was in left armpit. Had fever, chills and headache this same day requiring me to take round the clock doses of Tylenol. By the following day, fever and chills were gone but swelling of armpit still present. Swelling is slowly diminishing but still present by day 3, as I send this notification.
60 2021-01-10 headache, fatigue dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nau... Read more
dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath
60 2021-01-10 fatigue, chills fatigue, chills started about 8 hours after the vaccine; went to bed early and by 24 hrs the reacti... Read more
fatigue, chills started about 8 hours after the vaccine; went to bed early and by 24 hrs the reactions had gone away. No pain at the injection site.
60 2021-01-10 fever, fatigue four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and incre... Read more
four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls
60 2021-01-10 chills, fever nausea,weakness,chills , fever , muscle and joint pain , no appetite
60 2021-01-11 headache Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheez... Read more
Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.
60 2021-01-11 cough Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inh... Read more
Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inhaler for 3-4 inhalations. Given Epinephrine, Benadryl, Solu-Medrol IM injections administered. 2L O2 via NC applied. Elevated BP and HR noted. Patient transported to ER. Duo-Neb nebulizer treatment provided. Bronchospasm and Wheezing subsided after approximately 45 minutes. Patient discharged hone with Prednisone and EPI pen prescriptions.
60 2021-01-11 headache Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat an... Read more
Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest
60 2021-01-11 chills, fever, headache, fatigue Fever; chills; headache; fatigue; This is a spontaneous report from a non-contactable other HCP (pat... Read more
Fever; chills; headache; fatigue; This is a spontaneous report from a non-contactable other HCP (patient) reported for herself. A 60-years-old female patient received first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, in left arm, on 05Jan2021 13:00 at single dose for COVID-19 immunization. Reason why batch/lot is unknown was misplaced/discarded. The patient was not pregnant at the time of vaccination. Medical history included known allergies: Penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced fever, chills, headache, fatigue on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the events was recovering. Since the vaccination, patient hasn't been tested for COVID-19. No follow-up attempts are possible, information about lot/batch cannot be obtained.
60 2021-01-11 headache, fatigue, chills, fever Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point;... Read more
Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.
60 2021-01-11 chills TEMP 99 AFTER TYLENOL s shaking chills
60 2021-01-11 chills, headache developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tyleno... Read more
developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tylenol, used heating pad
60 2021-01-12 fatigue, headache, chills About 22 hours after administration I had chills, headache,blood shot eyes, total body aches and ext... Read more
About 22 hours after administration I had chills, headache,blood shot eyes, total body aches and extreme fatigue. I slept off and all day and at 3:00 am 1/13/2021 I woke up and felt much better. chills, headache and body aches all gone. Some fatigue still lingers. I did not have fever at any time.. My arm injection site was less sore than the first vaccine.
60 2021-01-12 fever Fever for over 24 hours. Temp 101.9
60 2021-01-12 headache, throat irritation, throat pain Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on he... Read more
Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on her neck and chest. Denies difficulty breathing however she reports her throat is very painful, scratchy, dry and irritated. For treatment patient took a zyrtec 24 hour 10 mg tablet on 1/11/21 which reduced some inflammation of rash, however still present 1/12/21. Has increased fluids, is taking tylenol and tea with honey. These were self care done by patient. MD suggested to Zyrtec every 6-8 hours as needed for symptom control. Ibuprofen / tylenol as needed for headache if no provider has told you not to use these in the past. If any progressive Sx than you should be seen at URI clinic.
60 2021-01-12 headache Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; ... Read more
Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 04Jan2021 14:56 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, previously had an allergic reaction to just one antibiotic. Concomitant medication included nifedipine, carvedilol. Consumer stated, "About 15 minutes into after getting the injection, I was sitting to the site they asked me to stay longer because I previously had an allergic reaction to just one antibiotic (Unspecified Medication).So that was within the 15 minute mark I started getting ringing in my ears and at the 20 mark I had migraine. I had them since I was about 9, they were diagnosed, it triggered a migraine. Although the ringing had gotten better in the last year but it is really bad in the right and it is now causing me (incomplete sentence)." Consumer stated, "I am probably say like I am yelling at you. I cannot hear and my son keeps telling me mom you are yelling. I did not see that I am 'ringing to your sheath' ringing in the ear, the headache. I just see my headache is better today. I had a little bit of it but nothing you know Excedrin or something would take care of not enough for me to go take that but it is the ringing and I cannot hear out of that ear. I put my phone up and ringed up. Consumer stated, "Recently my mom had COVID (further not clarified), I barely heard it. On the 23rd of Dec and I keep in contact with my family,they are 13 of us and I picked up the phone and instinctively put it to my right ear, I could not hear and I kept looking at the phone and I thought wait a minute and I put it to my left seems to be okay. It is the right I cannot hear." Consumer further added, "I am a Nurse so you expect this, that is why I waited this long because I got the injection at like 3 O'clock yesterday and I waited even longer thinking maybe it will just go away and So I know you guys want to know everything that is going on. So I said wise better to call." Date of vaccination: Consumer stated, "04Jan2021 (Clarified as 04Jan2021) and the time was 2:56 PM." Consumer further added, "It is the only thing I could think of. It is the only thing that I could think of that I did differently out of my daily habits to go get this injection. I would say within 15 minutes it just started turning my head and I was like wait a minute I am having ringing and then they had music playing above our head, it sounded like everything was muffled then I turn my head to the right I could hear better and they kept turning my head and one of the administrators at the table started looking at me so I get up and I said you know what I am having ringing in my ear so they had me seated there a bit longer." Dose and route of administration: Consumer stated, "I think she pulled up one cc that I saw and I got it in my left deltoid." Treatment: Consumer stated, "No." Causality: Consumer stated, "I would have to say because it started like say in the 15 minute mark and then the headache came in about 20 minute mark." The outcome of the event Headache was resolved while the outcome of the other events was unknown.
60 2021-01-12 headache, body temperature increased achy knees/ achy joints/ achy right elbow; Headache; her temperature was 96, but not a fever; Achy b... Read more
achy knees/ achy joints/ achy right elbow; Headache; her temperature was 96, but not a fever; Achy back; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (Batch/lot number: EJ1685, Pfizer product), via an unspecified route of administration in in left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was receiving concomitant therapy. The patient previous received first dose of BNT162B2 on 08Dec2020 and experienced left arm a little sore at the injection site. The patient experienced achy knees/ achy joints/ achy right elbow, headache, her temperature was 96, but not a fever, achy back, all on 07Jan2021. She got her 2nd vaccine (COVID-19 Vaccine) on 06Jan2021 and this morning, the longer the morning goes on, she felt achy, has a headache, feels like she has a fever but does not. Had temperature taken this morning going into work and it was 93. Just now, her temperature was 96, but not a fever. She stated that this was nothing major, but the information she received said to call and report anything. First temperature taken this morning was from a forehead thermometer. The type of thermometer used for her second temperature this morning was not provided. She was a secretary for environmental services at the hospital she works at. She stated that she thought she could go to work and had to leave. She was going to bed as soon as she hangs up. Height: she used to be 5 feet 8 inches. She was counting on feeling better by tomorrow. She further described her achy feeling as her joints are achy including her knees, back and her elbow, but only her right elbow. She received the injection in her left arm. All she wanted to do now, was to crawl into a warm bed. She stated that she was fine after the first shot. Her arm was a little sore and that was it. She had her first COVID-19 Vaccine injection in her left arm. The soreness at the injection site lasted 2 days and then recovered completely. She did not provide her concomitant medications, stating that she took the same medications that she usually took and had not started anything new. She stated that she was 60 and has the what she had, but she did not have anything of concern; further stating that she had no breathing difficulties or anything like that. The patient underwent lab tests and procedures which included body height: 172.72 cm, body temperature: 93, body temperature: 96, all on an unspecified date. The outcome of events was not resolved.
60 2021-01-13 sleepiness, headache Within 15 min of admin; pt reported feeling super drowsy and complained of Headache. She was given w... Read more
Within 15 min of admin; pt reported feeling super drowsy and complained of Headache. She was given water and Acetaminophen, 25mg of Diphenhydramine. BP 140/64 Pulse 74
60 2021-01-13 headache flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness... Read more
flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness in the arm; little headache; experiencing tingling in hands and feet (mostly in feet); experiencing tingling in hands and feet (mostly in feet) and they feel cold; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route on left upper arm at single dose for COVID-19 immunization on 05Jan2021, 12:30pm at 60-year-old. Medical history included: ongoing diabetes type 2; ongoing gout; went through menopause 10 years ago (2011). She had pulmonary emboli 3 years ago (2018) and had some scar tissue but not on oxygen though she did get short of breath. No relevant family medical history. The only reactions she has ever had was 15 years ago (2006), she had a CAT scan and experienced hives the next day due to the contrast medium. She thought it had since been changed as she had had it twice since then and was given diphenhydramine hydrochloride (BENADRYL) but experienced nothing again. Concomitant medication included: ongoing dulaglutide (TRULICITY) for diabetes type 2 and ongoing oral medication (unspecified) for gout. No additional vaccines administered on same date of BNT162B2. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) single dose for COVID-19 immunization on 19Dec2020 around 12pm and 2 pm. The patient previously got the flu shot (unspecified) every year, 3 years ago (in 2018) she got the shingles vaccine and had also had the pneumonia vaccine (in 2018) but never experienced anything from those products. The patient previously took allopurinol for pulmonary emboli and had had no reoccurrence. She took warfarin for short of breath. The patient had flushing on 05Jan2021, she was hot and turned red like a cherry. She had an episode where she felt really hot like hot flashes or almost like she was flushed. Her face was red as beet and her arm and hands were red, this lasted about an hour and she took ibuprofen (ADVIL) for it. It seemed to be resolved but had come and gone through the night. She was up checking on her puppies so that was how she noticed. She had taken her temperature and it had been 97.6-98.1 which was normal for her, but she was still getting the hot flashes and flushing. She felt feverish and it was not a rash, she just felt flushed. After the vaccine, the patient reported soreness in the arm on 05Jan2021. The patient was experiencing tingling in hands and feet (mostly in feet) on 05Jan2021 and they feel cold. Tingling started about 45 minutes to an hour after the dose. The first time lasted 3-4 hours and then went away. It came back in the middle of the night for a couple hours and then again this morning. This morning it had been going on for 2-3 hours and was still going on right now; it started about 6:30am-7am. They feel cold but her feet were really cold. She had socks and slippers on, but they didn't seem to get warm. She went on to explain that her hands and feet have profusion. During this she had checked her pulse ox (oximetry) related to her cold hands and it had been 92-95% (on unknown date) which was good. She had also checked her pedal pulses even though they were cold, and a little they were a little on white side, they blanch although might be a little slow but nothing alarming. The patient had a little headache on 05Jan2021. Other than that, the patient felt fine. No emergency room or physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events flushing, hot/ felt really hot, soreness in the arm, tingling in hands and feet (mostly in feet) and they feel cold was not resolved; outcome of the other events was unknown. Causality assessment between the Pfizer product (BNT162B2) and the events (tingling, flushing, soreness in the arm) per the reporter was reported as related.
60 2021-01-14 chills, headache Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-... Read more
Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration on 08Jan2021 11:45 AM at single dose on the right arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), on 18Dec2020 12:00 PM on right arm. COVID-19 vaccine was administered in the hospital. The patient experienced chills, nausea and headache on 09Jan2021 01:30 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
60 2021-01-14 chills, fatigue, headache Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus,... Read more
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.
60 2021-01-14 fever, chills Fever 38.8 Chills Muscle and joint pain
60 2021-01-14 fatigue, headache Headache, Body Aches, Fatiguenone
60 2021-01-14 chills, fever, headache I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in... Read more
I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.
60 2021-01-14 fever, chills, fatigue, headache Low grade fever, chills, headache, fatigue
60 2021-01-14 headache, fatigue, chills, fever Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of ap... Read more
Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of appetite, fatigue.
60 2021-01-14 fatigue Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection... Read more
Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.
60 2021-01-14 headache, fever, chills this was my second shot for covid, experienced chills fever bad headache
60 2021-01-15 cough, fatigue I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor ... Read more
I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor difficulty breathing. I had an increased you can buildup up in my throat and nose, with coughing. I took two Benadryl; about 45 minutes later my breathing improved. I took the Benadryl at 8:15 AM. It?s now 2:25 PM and my eyes are getting itchy and starting to feel puffy again. My voice is still very hoarse.
60 2021-01-16 headache 1) I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was br... Read more
1) I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was briefly dizzy but only for a few seconds at most. 2) By the time I reached my car, I had developed a mild headache which lasted until around noon the next day. The headache was not severe. 3) Shoulder that received the shot was sore for about two days.
60 2021-01-16 malaise, body temperature increased, throat irritation, fatigue Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: ... Read more
Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.
60 2021-01-17 headache 01/05/2021 AT 6PM: BODY ACHES, SEVERE HEADACHES. LOCAL SORENESS, SWELLING
60 2021-01-17 sweating Clammy, sweating and rash to BUE and chest. Patient will be seeing PCP for treatment.
60 2021-01-17 throat irritation PATIRNT PRESENT THROAT AND BODY ITCH
60 2021-01-17 headache, malaise SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT M... Read more
SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT MORNING. ALL LASTED UNTIL ABOUT 28 HRS POST VACCINE.
60 2021-01-18 nasopharyngitis, throat pain, fatigue 6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN... Read more
6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN. TOOK TWO BENEDRYL AND SYMPTOMS RESOLVED BY AM. 1/16 HAD SYMPTOMS OF AN ON-COMING COLD, SLIGHT SORE THROUGH, SINUS PRESSURE AND FELT WARM. NO TREATMENT OTHER THAN FLUIDS AND REST AND RESOLVED BY MORNING. 1/17 AND 1/18 ONLY SYMPTOM MILD FATIGUE
60 2021-01-18 malaise Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and fo... Read more
Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening
60 2021-01-18 headache Daily Headaches
60 2021-01-18 throat pain, headache, malaise, fatigue Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Head... Read more
Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.
60 2021-01-18 fever, malaise Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lun... Read more
Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lunch and in the evening started feeling nausea and was throwing and abdominal pain. Went to work sick Tuesday and Wednesday low grade fever, nausea and abdominal pain, wasn't eating was to sick to eat. Thursday early morning hours the pain was unbearable so she went to the ER and the cat scan. It was determined that she had appendicitis and they removed my appendix same day. Feels so much better now.
60 2021-01-18 fever Systemic: Fever-Medium, Systemic: rapid heartbeat-Medium
60 2021-01-18 malaise WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE M... Read more
WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH
60 2021-01-18 runny nose Watery eyes, runny nose
60 2021-01-18 fever, influenza like illness, chills fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt rea... Read more
fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension. Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.
60 2021-01-19 fatigue, throat pain, cough, fever, headache Cough, fever, headache, sore throat,fatigue
60 2021-01-19 headache Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. To... Read more
Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching
60 2021-01-19 throat irritation Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart ra... Read more
Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.
60 2021-01-19 fatigue, headache, chills chills, headache, body aches, loss of taste, flush, red eyes, extreme fatigue
60 2021-01-20 fever, chills 1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later.... Read more
1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums
60 2021-01-20 fatigue Heart palpatations, fatigue, light hededness
60 2021-01-20 sweating Received vaccine at 1:10pm. At 1:30pm, while in observation lot,patient complained of chest pressur... Read more
Received vaccine at 1:10pm. At 1:30pm, while in observation lot,patient complained of chest pressure 8/10 and appeared ashen and diaphoretic. Paramedics from the vaccine facility immediately responded to the patient. Patient stated these were the same symptoms she has had in the past when she has an allergic reaction, and stated she has reactions to 10 different "things". Patient carried an epi pen but stated she usually went to the ER and was treated there. On-site paramedics gave 0.5 mg IM to Left deltoid. Patient stated chest pressure went down to a 3/10, and she felt better. Ambulance arrived and patient was transported to Hospital.
60 2021-01-20 sleepiness Very sleepy 4 hours after second dose; This is a spontaneous report from a contactable healthcare pr... Read more
Very sleepy 4 hours after second dose; This is a spontaneous report from a contactable healthcare professional (patient herself). A 60-year-old female patient received the second dose of bnt162b2 (lot number: Ek9231), intramuscularly on the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient was not pregnant. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (lot number: Ek5730) intramuscularly on the right arm on 22Dec2020 at 08:00 AM. On 11Jan2021 14:00, the patient became very sleepy four hours after second dose. The patient was recovering from the event. No treatment was given in response to very sleepy 4 hours after second dose.
60 2021-01-20 fatigue Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up i... Read more
Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.
60 2021-01-20 fever, fatigue, chills chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontane... Read more
chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration at left arm on 08Jan2021 at 09:30 at single dose for COVID-19 immunization. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing and COVID-19 from Oct2020 (as reported: "I had been diagnosed with COVID-19 on 21Oct2020 with symptoms onset on 15Oct2020") to an unknown date. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY), aspirin, calcium/cholecalciferol (CALCIUM + D3), docusate. The patient previously took COMPAZINE and BACTRIM DS and experienced allergies. The patient reported that on 08Jan2021 at 21:00 developed chills, fatigue, deep muscle aching in both arms and fever ranged between 100- 101 F. On 09Jan2021 at 09:00 he felt fine, until approximately 17:00 and again developed chills, muscle aching and fatigue. On 10Jan2021 at 08:30 all symptoms were gone and never returned. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 21Oct2020. The patient outcome of the events was recovered on 10Jan2021 at 08:30.
60 2021-01-20 fatigue, chills, fever, headache chills; headache; fatigue; fever 101; body aches; This is a spontaneous report from a contactable he... Read more
chills; headache; fatigue; fever 101; body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in right arm on 09Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included hypothyroidismand arthritis from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), progesterone and estradiol (DOTTI). The patient previously took ace inhibitors and experienced allergies. The patient had first dose of BNT162B2, via unspecified route of administration on 18Dec2020 11:00 AM, lot number: EK507, in right arm at single dose for COVID-19 immunization. On 09Jan2021 2:30 AM, the patient woke up and experienced chills, fever 101, headache, fatigue and body aches and it lasted most of the day. The patient went back to bed at 8:30 PM and still had fever 100.2 and fatigue but most other symptoms getting better. The patient woke on 10Jan2021 at 4:30 am for work, no fever and some fatigue but that was it. No other reactions since this writing. The outcome of the event fever was recovered on 10Jan2021 and the outcome of the remaining events was recovering. No treatment was given for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
60 2021-01-20 body temperature increased, chills, headache received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working after... Read more
received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working afternoon progressed to chills and total body aches. temp 101 through evening up and down after motrin to next day Wednesday. wednesday had some chills but during night into Thursday had joint pain no fever. woken up thursday with joint pain and headache no fever.
60 2021-01-20 headache taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the co... Read more
taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
60 2021-01-21 fatigue Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complet... Read more
Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complete lapse in memory of event I talked to a person just the day before. (Never happened before) Today, 1/22/21 I was sitting at my desk talking to another person and fainted for no reason. (Never happened before). I came to and after short while felt better.. Left work to rest at home. Have not seen a doctor yet but worried about 2nd vaccine dose. The syncope episode concerns me.
60 2021-01-21 fever, lethargy LETHARGY AND LOW GRADE FEVER
60 2021-01-21 fever, headache, chills Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs afte... Read more
Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs after vaccination and lasted approximately 36 hours.
60 2021-01-21 headache, fatigue right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/d... Read more
right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/discomfort
60 2021-01-24 chills, headache, sweating 12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours l... Read more
12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
60 2021-01-24 dehydration Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walkin... Read more
Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.
60 2021-01-24 headache, fever Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at s... Read more
Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days
60 2021-01-24 throat irritation Patient had tingling in the mouth and a scratchy feeling in her throat. Evaluated by EMS.
60 2021-01-24 throat irritation Patient has history of anaphylaxis, and carries her own EpiPen. Patient received dose 2 at 1640, ... Read more
Patient has history of anaphylaxis, and carries her own EpiPen. Patient received dose 2 at 1640, and was instructed to wait in observation area for 30 minutes. At 1650 patient reported that her tongue and back of throat were beginning to itch. No other symptoms. No difficulty breathing. Vital signs stable. Symptoms persisted, so decision was made to send patient to hospital emergency department. Patient did not want emergency transport, and was stable, and husband transported to hospital in POV. Onsite and hospital care team agreed to this plan. RN escorted patient from clinic to car. Patient and husband knew how to use EpiPen and drove directly to nearby ED for observation.
60 2021-01-24 chills, fatigue Severe fatigue, muscle weakness and chills
60 2021-01-24 head discomfort, headache, influenza like illness, chills, body temperature increased Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate... Read more
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-01-25 nasal congestion Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestio... Read more
Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.
60 2021-01-25 fever, headache, fatigue Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentra... Read more
Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.
60 2021-01-25 headache, fever, chills Fever 103.5, shaking chills, headache, pain in chest on inspiration
60 2021-01-25 fatigue, headache Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizz... Read more
Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.
60 2021-01-25 cough Pfizer BioNTech COVID-19 Vaccine EUA approximately 10 minutes after receiving her second dose, patie... Read more
Pfizer BioNTech COVID-19 Vaccine EUA approximately 10 minutes after receiving her second dose, patient report throat tingling and tightness. Later started to have an intermittent cough
60 2021-01-25 throat irritation, headache Pfizer-BioNTech COVID- 19 Vaccine EUA Symptoms included exacerbated blood pressure of 200/90, chest... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Symptoms included exacerbated blood pressure of 200/90, chest tightness, itching throat, and headache,
60 2021-01-25 chills, fever Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took... Read more
Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took a Tylenol went back to bed. No fever upon waking. Minor muscle aches and mild soreness at injection site.
60 2021-01-25 headache, fatigue Very fatigued, HA, Body aches, symptoms resolved within 48 hours
60 2021-01-25 chills Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myal... Read more
Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myalgias; This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 22Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). There were no concomitant medications. The patient experienced very swollen and erythematous arm, chills, severe neck pain, myalgias, all on 22Dec2020 14:00. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment given. The outcome of events was resolved. Facility type vaccine: Hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. Not known allergies or other medical history.
60 2021-01-25 fatigue Very tired; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient ... Read more
Very tired; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). The patient experienced very tired on 12Jan2021 with outcome of recovering. Information on the lot/batch number has been requested.
60 2021-01-25 headache body aches; major headache all night long, all over her head. It was a pressure headache; This is a ... Read more
body aches; major headache all night long, all over her head. It was a pressure headache; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E49899), via an unspecified route of administration in the right deltoid on 18Dec2020 10:30 at a single dose for COVID-19 immunization. The patient's medical history included wolff-parkinson-white syndrome (WPW syndrome) from 2000, heart surgery from 2000, and allergic to sulfa with hives. Mother is diabetic and sister is prediabetic. There were no concomitant medications. On an unspecified date, she experienced body aches. She took paracetamol (TYLENOL). She also had major headache all night long, all over her head. It was a pressure headache. Someone gave her ibuprofen (MOTRIN) and within 3 hours she was totally fine. Outcome of the body aches was unknown and of the headache was recovered on an unspecified date.
60 2021-01-25 fever, fatigue, headache, malaise horrible headache; felt really bad; 102 fever; achy; fatigued; This is a spontaneous report from a c... Read more
horrible headache; felt really bad; 102 fever; achy; fatigued; This is a spontaneous report from a contactable other health professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 12Jan2021 11:15 AM, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Medical history included known allergies to penicillin and COVID. The patient had COVID prior to vaccination. Concomitant medications included lisinopril and escitalopram; these are the other medications the patient received in two weeks. The patient previously took betadine and experienced allergies. On 13Jan2021 02:30 AM (as reported), the patient experienced a horrible headache, felt really bad, 102 fever, achy, and fatigued. The patient woke up at about 2:30 am and had a horrible headache. Got out of bed at 4:30 and felt really bad. She had 102 fever. She was still running 100 at 5:42 pm. She was achy, still have a headache and am very fatigued at the time of report. She asked if she can take something for the fever and headache. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was not recovered. Information on the Lot/Batch number has been requested.
60 2021-01-25 chills, headache, fever increased postnasal drip; had a fever of 100.7 orally; bodyaches; headache; chills; This is a sponta... Read more
increased postnasal drip; had a fever of 100.7 orally; bodyaches; headache; chills; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient (not pregnant) received the second dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 09Jan2021 09:30 at single dose in right arm for COVID-19 immunization. Medical history included asthma, hypertension/ Blood pressure, acid reflux, food allergies, Known allergies: tree nuts, peanut, shell fish, Penicillin, Erythromycin, IVP dye, Rocephin. The patient's concomitant medications in two weeks included Blood pressure, acid reflux. The patient previously took the first dose of bnt162b2 on 19Dec2020 for COVID-19 immunization and experienced Sore arm. No other-vaccine-in-four weeks. Second dose on 09Jan2021 within 17 hours had a fever of 100.7 orally, body aches, headache, chills and increased postnasal drip on 10Jan2021 02:30. No treatment received. No covid-prior-vaccination and no covid tested post vaccination. The outcome of the events was recovering.
60 2021-01-26 cough C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccin... Read more
C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids
60 2021-01-26 chills, headache Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that c... Read more
Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.
60 2021-01-26 nasal congestion, runny nose allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath... Read more
allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it. Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
60 2021-01-26 headache like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes ... Read more
like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was "like an anaphylactic reaction but not in her throat." itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-01-27 fatigue, fever Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection howeve... Read more
Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection however the fever has continued x7 days, getting as high as 101.9. I began noticing soreness in the lymph nodes in my neck and underarms on the evening of 1/25 and that lasted until midmorning of 1/27.
60 2021-01-27 chills Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old... Read more
Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left upper arm on 11Jan2021 around 3:45-4:00pm at a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medication included levothyroxine from 2006 for hypothyroidism. The patient was administered the first dose of Pfizer-BioNTech COVID Vaccine on 11Jan2021 at work. On 12Jan2021, the patient experienced muscle pain, chills, nausea. The outcome of the events was not recovered. The patient underwent rapid COVID-19 nasal swab test and the result was negative on 12Jan2021. Second dose scheduled to be administered on 01Feb2021 with no dose change made. Information on the Lot/batch number has been requested.
60 2021-01-27 chills Red, warm rash around injection site cold sweat, chills, and swelling to Left arm
60 2021-01-27 fatigue body aches and fatigue lasting 48 hours after the vaccination
60 2021-01-28 headache, fever 101 fever, body aches, headache, joint aches
60 2021-01-28 cough After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me an... Read more
After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me antibiotics. They also gave me an inhaler for my wheezing. I also felt a tightness sensation in my chest and lungs from all the coughing.
60 2021-01-28 fatigue, fever, headache, chills Chills, Fever, Headache, Fatigue, Body aches;12 hrs duration; treated with Tylenol
60 2021-01-28 fever, fatigue FEVER AND FATIGUE
60 2021-01-28 influenza like illness, nasal congestion, headache FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT C... Read more
FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.
60 2021-01-28 chills, headache, fatigue Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneo... Read more
Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
60 2021-01-28 fatigue, headache, cough, chills, malaise, fever I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to ... Read more
I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to feel malaise and fatigue. Upon waking around midnight, I had developed a 102.4 degree (F) fever, total body ache, headache, chills, and cough. Most symptoms lasted approximately 24 hours. The headache, although now mild, persists into the third day. On the third morning following the injection, I woke to find a slightly painful triangular-shaped red, raised patch on the same arm as the injection (left). The "rash" measures approximately 4.5 cm x 7 cm.
60 2021-01-28 headache Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain ... Read more
Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache
60 2021-01-28 body temperature increased My wife had a temperature of 102 and has since gone down a little bit to 101.
60 2021-01-28 fatigue, malaise day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling cru... Read more
day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......
60 2021-01-28 cough itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued ... Read more
itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued and plateaued for hour and half. Benadryl and prednisone given in ED. Monitored and D/C with no further progression of sx.
60 2021-01-28 nasal congestion nasal congestion. chest congestion. chest discomfort. Has been persistent to today 1/29/21.
60 2021-01-29 fatigue, nasopharyngitis, headache, chills Headache, cold chills, body ache started about 10:00am on 1/29/2021. It is now 1/30/2021 @ 7:56pm a... Read more
Headache, cold chills, body ache started about 10:00am on 1/29/2021. It is now 1/30/2021 @ 7:56pm and still have a headache and feel tired as have been all day.
60 2021-01-29 nasal congestion, body temperature increased, runny nose, fatigue Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt ... Read more
Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt fine the next morning.
60 2021-01-31 fever, headache, chills 6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days... Read more
6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.
60 2021-01-31 headache, malaise, fatigue nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tir... Read more
nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.
60 2021-02-01 fever, headache FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOU... Read more
FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOURS
60 2021-02-01 fatigue, throat pain, sleepiness, headache, fever Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but... Read more
Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but sleep; administration date=15Jan2021 (dose number: 2); administration date=23Dec2020 (dose number=1); This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 15Jan2021 at 13:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies when younger, known allergies to wheat, dairy, cats, and mold. There were no concomitant medications. The patient previously took levofloxacin (LEVAQUIN) and nitrous oxide and experienced allergies; also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) on 23Dec2020 at 11:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient experienced fatigue, headache, earache, sore throat, and fever of 101.4 for 24 hours, and diarrhea. The patient could do nothing but sleep. The patient did not receive any treatment for the reported events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
60 2021-02-01 fever, headache Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This starte... Read more
Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2. Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.
60 2021-02-03 lethargy, chills, headache 11pm evening of shot woke with body aches. Approx. 2am woke again with extreme chills, headache & na... Read more
11pm evening of shot woke with body aches. Approx. 2am woke again with extreme chills, headache & nausea. Somewhat lethargic throughout the day but no symtoms other than slight headache. Woke the next morning at 3am with extreme chills again. Seem to feel ok but not 100% today.
60 2021-02-03 fatigue, headache I got up and had a really bad headache and fatigue. I did not go to work due to the headache. I to... Read more
I got up and had a really bad headache and fatigue. I did not go to work due to the headache. I took a Tramadol, got an ice pack, placed it on my head and put some lavender on my pillow, called into work and went back to bed. I still have the headache and fatigue, but I am able to work so far.
60 2021-02-03 chills, fever, fatigue I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I st... Read more
I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I still have chills,fever,muscle aches and fatigue. I am going for a covid test today.I have missed days of work due to this vaccine.
60 2021-02-03 chills Rigors that lasted about 10 minutes at around 45 mins to 1 hour post vaccine. Elevated heart rate.
60 2021-02-03 fever, chills Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hour... Read more
Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hours later she began having fever, chills and muscle aches. Fever improved with Motrin.
60 2021-02-03 chills chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a c... Read more
chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 11Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included citalopram, topiramate, zinc, and ergocalciferol (VIT D). On 12Jan2021 07:00, the patient started having chills in the morning that was gradually increasing throughout day. At 6:00pm, that patient had major chills and could not warm up. The patient got into the bed with numerous covers. She was cold all night. The last time she woke up was at 3:00am, and then when she woke at 6:00am, and she was fine. No treatment was received for feeling cold. Clinical outcome of the events was recovered on an unspecified date. Information about lot/batch number has been requested.
60 2021-02-03 headache light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healt... Read more
light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks. On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.
60 2021-02-04 chills, fever 1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that da... Read more
1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'
60 2021-02-04 headache, fever 12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache o... Read more
12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.
60 2021-02-04 headache, fever, chills After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chil... Read more
After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chills & body aches, a fever & a headache
60 2021-02-04 throat pain, fatigue, headache Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache w... Read more
Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.
60 2021-02-04 headache headache dizziness
60 2021-02-06 headache, fatigue High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking ... Read more
High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.
60 2021-02-07 sleepiness 12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down,... Read more
12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down, episode of syncope. Chest discomfort. ER for observation
60 2021-02-07 headache, fever high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; ... Read more
high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.
60 2021-02-08 influenza like illness, chills, headache her face got swollen; lymph node right there it was extremely swollen and very tender and very painf... Read more
her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.
60 2021-02-09 fatigue, fever fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22De... Read more
fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22Dec2020, second dose 15Jan2021; first dose 22Dec2020, second dose 15Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) on 15Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient previously received first dose of BNT162B2 (lot number: EL0140) on 22Dec2020 at single dose for COVID-19 immunization, and experienced fatigue, low grade fever and rash. The patient received the vaccine and had minor side effects that were explained like fatigue, low grade fever, everything responded to the ibuprofen (ADVIL) a NSAID. The booster received on time on 15Jan2021 and she had a quite a challenge with it for about a week, she had the increased fatigue, really incredible body ache, the fever went away in about 2 days but fatigue lasted definitely a full week. About the 3rd day a rash started and that was not going away, she was not sure what to so about it, it became worst if she exercise, very prominent if she exercise. It's been a little over a week with symptoms of fatigue and body ache went away. The rash that she can not get rid of; It was very disturbing the rash; looks like measles on her face. Treatment included the body ache was responding to ibuprofen but fatigue she just trying to take more rest. Lab data included CBC (Full blood count) on unspecified date, that was normal. The outcome of fatigue, low grade fever, incredible body ache was recovered on unspecified date, outcome of other events was not recovered. Causality assessment from the reporter between the vaccine and events was related.
60 2021-02-09 fever, chills, headache positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm right on 20Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included diabetes from an unknown date and ongoing. The patient's concomitant medication included metformin. The patient experienced COVID-19 on 27Jan2021 (she got all the symptoms: sinus, headache, body aches, pain, chills, joint pain, fever). The patient was admitted to emergency room due to the event. The patient underwent lab test and procedure which included blood test and chest X-ray both on an unspecified date and both resulted that "everything was good" values not provided, in Jan2021 body weight: between 114-115 lbs, but probably 110 (lost a lot of weight in the past two weeks because of the virus) and SARS-CoV-2 test (nasal swab): positive on 27Jan2021. Therapeutic measures were taken as result of COVID-19 and included treatment with benzonatate (lot: 7893614, dose: 100 mg; one pill a day), ivermectin (dose: 3 mg, 4 pills a day for 2 days, exp: 28Apr2021), prednisone (dose: 20 mg, 3 tablets once daily lot: 7893618 ), azithromycin (dose: 500 mg, for five days, lot: 7893308). Medications she was prescribed in the emergency room were helping a little bit. The patient outcome of the events was unknown.
60 2021-02-09 fever, cough positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.
60 2021-02-16 fatigue 2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs,... Read more
2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs, down thighs at bedtime, under arms), rash was spreading, pt put calamine lotion on rash, woke up 2/17/21 and rash is gone.
60 2021-02-16 fatigue, chills, headache Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for... Read more
Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.
60 2021-02-16 cough Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccinati... Read more
Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.
60 2021-02-17 fever This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female pat... Read more
This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation . Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before). Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation. Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00 temperature of 100.6, arthralgias and myalgias, dizziness. Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness, Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias was recovering.
60 2021-02-17 malaise lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded... Read more
lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
60 2021-02-21 throat irritation During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations... Read more
During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.
60 2021-02-21 headache, fatigue, chills Woke up during the night with chills that had my body shivering and a headache. Did not get up unt... Read more
Woke up during the night with chills that had my body shivering and a headache. Did not get up until morning because I didn't want to get out of the covers even though I was cold. Took some ibuprofen which helped with both the chills and headache. I had no energy and was very tired. I slept most of the day and woke up to go to the bathroom and take more ibuprofen. Towards the evening I could tell that I was feeling a bit better. I was able to take a bath, more ibuprofen and went to bed. Slept pretty well. Woke up once and took ibuprofen because of headache and body aches. Felt much better on Sunday. Was still tired and slept a good part of the day. My arm continues to ache, but is not really painful unless I try to lift it.
60 2021-02-22 headache, fever Fever, Body ache, headache
60 2021-02-22 lethargy, fever Very lethargic, feverish, SOB
60 2021-02-22 pneumonia, chills presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to i... Read more
presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to initially be systemic SEs from the vaccine but found to have re-collapse of the BI on chest CT with probable post obstructive pneumonia. still admitted as of 2/23/2021
60 2021-02-23 fatigue, fever, headache 2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tir... Read more
2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tiredness, - Tylenol every 5 hours 2/14: fever 99 F, body ache, headache, tiredness, hives on chest, stomach, back, arms, - Tylenol every 6 hours 2/15: no fever, hives fading out 2/16: tiredness, hives cleared up
60 2021-02-23 fever, chills I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's pos... Read more
I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today
60 2021-02-23 runny nose, chills Other than mild soreness at the injection site she experienced no adverse reactions during the first... Read more
Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation
60 2021-02-24 fatigue 10 min. After shot developed rash to chest, torso. On 4th day developed SOB, chest pain and fatigue.
60 2021-02-24 fatigue, headache Approximately 4 hours after injection, I developed a severe, one sided headache. Extreme fatigue dev... Read more
Approximately 4 hours after injection, I developed a severe, one sided headache. Extreme fatigue developed the following morning, headache less severe. Extreme fatigue continued for 6 days, headache for 5 days. OTC analgesic was not helpful.
60 2021-02-24 malaise, headache, sweating Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details:... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins
60 2021-02-25 cough Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2... Read more
Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2 antibiotics. She was given 25 mg of benadryl and symptoms improved. She was given instructions to take more benadryl in 4 hours to help with symptoms and to go to the ED if symptoms got worse
60 2021-02-25 fatigue, headache third day, fatique, headache, aching joints
60 2021-02-26 fever, fatigue, chills Chills fever fatigue
60 2021-02-26 fever Fever 101.1, aching joints, shortness of breath that I still have week later, loss of taste,
60 2021-02-26 fever, chills, fatigue, headache IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatig... Read more
IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever
60 2021-02-26 headache Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2... Read more
Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2 97% on intial check. She also reported a right frontal headache 5/10. Moved to cot to lie down, VS re-checked. Dizziness did not resolve with lying down. BP remained elevated as well. Once lying down, patient also reported "heaviness" in chest. A nurse remained with patient throughout entire incident and VS assessed frequently. After about 45 minutes, patient still reported HA, dizziness. Patient reported chest heaviness had resolved, but BP and dizziness did not resolve. Discussed calling EMS with patient, she agreed to allow us to call EMS. She was transported to local hospital by EMS at approximately 11:30am.
60 2021-02-27 headache At 48 hours After vaccines I developed a headache nauseous Hot the following day I was sore all over... Read more
At 48 hours After vaccines I developed a headache nauseous Hot the following day I was sore all over still having a headache still nauseous my ribs hurt my hand hurt four days today still not well tired weak headache! So sick ! I do not wish to have the second dose! I really thought I was gonna die
60 2021-02-27 malaise, cough, fever, headache Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Fri... Read more
Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.
60 2021-02-27 influenza like illness, fever That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches... Read more
That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain
60 2021-02-27 fever, fatigue, chills, influenza like illness slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss o... Read more
slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss of taste and smell, fatigue) since Wednesday 2/24/21. Missed work due to symptoms on Thursday 2/25/21. Returned to work amidst continuing flu-like symptoms on Friday 2/26/21. As of Sunday, 2/28/21, symptoms continue; maybe slightly diminished.
60 2021-02-28 fever, chills Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level ... Read more
Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.
60 2021-02-28 headache, fatigue excessive vomiting, nausea, headache, aches, fatigue
60 2021-02-28 headache, influenza like illness flu like symptoms, head ache, weakness, body aches
60 2021-02-28 headache pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw... Read more
pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes and overweight, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included lisinopril, metformin, metoprolol, sitagliptin (JANUVIA). The patient did not receive any other vaccine within 4 weeks of the vaccination. On 01Feb2021 at 09:00, the patient experienced multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcomes of multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain was resolving.
60 2021-03-01 sweating, headache, chills, fever Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't c... Read more
Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization. The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.
60 2021-03-01 headache, fatigue SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEA... Read more
SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEAT. DIZZINESS FOR APPROX 4 DAYS, HEADACHE FOR APPROX 4 DAYS
60 2021-03-02 respiratory tract congestion, headache, fever, chills, fatigue Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appet... Read more
Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.
60 2021-03-02 headache continued mild headache; eye strain and sensitivity to bright light; eye strain and sensitivity to b... Read more
continued mild headache; eye strain and sensitivity to bright light; eye strain and sensitivity to bright light; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM9810), via an unspecified route of administration in the left arm on 06Feb2021 at 10:15 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension (HTN), obstructive sleep apnoea (OSA), periodic limb movements of sleep (PLMS), arthritis, asthma, allergies to Band-aid adhesive, steristrips and lanolin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but the patient did receive concomitant medications within 2 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 16Jan2021 at 16:30 (at the age of 60-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccinations within 4 weeks prior to the COVID-19 vaccination. On 07Feb2021 at 00:00, the patient experienced continued mild headache, eye strain and sensitivity to bright light. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of continued mild headache, eye strain and sensitivity to bright light was not resolved.
60 2021-03-03 chills At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 1... Read more
At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 16 hours. I reported it to the nurse practitioner but did not want to see her because I knew it would resolve. I am a nurse and expected it would improve on it's own and it did. I did take Tylenol for the symptoms when they began. I work in a clinic.
60 2021-03-03 headache, malaise, chills, fatigue SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSE... Read more
SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL
60 2021-03-04 chills 4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling o... Read more
4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling on Face, Ankles, & Wrists -Very tired = fatigue / sleep
60 2021-03-04 chills I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was ... Read more
I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.
60 2021-03-04 cough, body temperature increased Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature ... Read more
Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9 The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.
60 2021-03-04 lethargy Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to ... Read more
Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to her, she appeared to be sleeping. She did wake after physical stimulus but was lethargic, confused & stated she "felt dizzy"
60 2021-03-04 fatigue, nasal congestion, cough, chills, headache Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on m... Read more
Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.
60 2021-03-04 throat irritation Scatchy throat, affected voice, swollen tongue
60 2021-03-04 throat pain Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my is... Read more
Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my issue. If symptoms worsen I will go to ER
60 2021-03-07 chills, fatigue Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in ... Read more
Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in all bones of body - face bones, leg and arm bones, ribs, etc. Thinking became foggy - everything became difficult to do. I went to bed at 7:30 pm on 2/25/2021 - slept fitfully until 6:30 am on 2/26/2021. All symptoms had lessened by 30%-50% during the day on 2/26/2021. By 2/27/2021, I felt pretty much like me again.
60 2021-03-07 headache, chills, influenza like illness, fatigue Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme... Read more
Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
60 2021-03-09 headache, fever, chills Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontane... Read more
Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 05Feb2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231) on 13Jan2021 at 01:45 PM for COVID-19 immunization (in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 06Feb2021 at 02:00 AM, the patient experienced fever ranging from 100 to 100.9 accompanied by chills and moderate headache as well. Fever subsided by the morning of 07Feb2021 and headache was mild by then. The patient also experienced soreness at site of injection on 06Feb2021 at 02:00 AM only if she touches it. No treatment was administered for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.
60 2021-03-14 fatigue swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (... Read more
swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 09:15 at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included AFib, hypertension, known allergies: TB test (allergies to medications, food, or other products: TB test). Concomitant medications included apixaban, digoxin, metoprolol, enalapril; the patient received all the drugs within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), in left arm on 20Jan2021 09:15 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced swollen lymph nodes, tiredness, diarrhea. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovering.
60 2021-03-15 fatigue, chills experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and bo... Read more
experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s
60 2021-03-16 headache A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back ar... Read more
A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back area which persisted to a heaviness in my chest going into Thursday. Thursday night I woke up in the middle of the night to the feeling of not being able to breathe. I laid awake for a while but dosed back off and it happened again a little later. It felt as if someone was sitting on my chest which prompted me to go to the ER the next day. Various test were done and I was admitted in the hospital for further observation. After admission I developed a massive headache which lasted from that Friday afternoon until that Sunday. I was released on that Sat and the symptoms seemed to be getting better and by that Sunday evening all symptoms had subsided.
60 2021-03-17 headache Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness ... Read more
Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-03-17 body temperature increased Temperature 103 degrees and weakness
60 2021-03-18 fatigue Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pa... Read more
Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-03-21 chills Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, for... Read more
Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-03-23 fever, fatigue, cough cough, fever and fatigue
60 2021-03-24 fatigue neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable cons... Read more
neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified route of administration on unspecified date at age of 60 years old at single dose for COVID-19 immunisation. Patient had chemotherapy for ovarian cancer in 2020. Concomitant medications were not reported. Patient experienced exhaustion, bone pain, neurothopy for 1-2 days post first vaccine. Event took place after use of product. Outcome of events was unknown. Information on the lot/batch number has been requested.
60 2021-03-25 headache things went black; my blood pressure was alarmed was over 200 checked other arm same called there te... Read more
things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-03-30 chills she tested positive for Sars-CoV-2 infection; she tested positive for Sars-CoV-2 infection; getting ... Read more
she tested positive for Sars-CoV-2 infection; she tested positive for Sars-CoV-2 infection; getting sick; got the chills; This is a spontaneous report from a contactable consumer (also mentioned being a Physical Therapist Assistant). A 60-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Batch/lot number: EN6203, Expiry Date: Jun2021, in Pharmacy/Drug Store, via an unspecified route of administration, in left arm on 26Feb2021 at 12:00, at 60 years of age, as single dose for COVID-19 immunization. Medical history included SARS-CoV-2 test positive in Nov2020 (COVID-19 Virus throat swab test was used), also reported as COVID-19 infection in Nov2020 with no symptoms, except a slight sore throat and gingival disorder from an unknown date. On 26Feb2021 the patient had no symptom, saying she felt great. She reported she worked out and was in great shape for her age. She said she was not the typical 60 year old. On 09Mar2021 in the evening the patient felt like she was getting sick and got the chills and she had never had that happen before, and didn't know if her symptoms were from the 2 pills of an herbal supplement she used for periodontal issues to strengthen her gums she had ordered online (she never saw the product in a store) and that she had taken on the same day; moreover she tested positive for SARS-CoV-2 infection on 11Mar2021 with a COVID-19 Virus 24-hour nasal swab test done at her work. The events didn't require visit to Emergency Room or Physician Office. It was reported that the patient was scheduled to receive her second dose of vaccine 19Mar2021 and the patient wanted to know if this is possible with her current diagnosis and how likely it is this is a false positive test for SARS-CoV-2. No treatment was administered for the reported events. At the time of the report the outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-04-01 fever, chills, headache Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Heada... Read more
Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Headache and fever continued, also had nausea and vomiting. On 3/5/3021, other symptoms resolved, but woke with double vision due to 6th cranial nerve palsy. This is the fourth acute occurrence of the nerve palsy. As of today, 4/2/2021, the double vision is still acutely present.
60 2021-04-03 malaise, headache, fever 12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post... Read more
12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.
60 2021-04-05 throat irritation Became nauseated has itchy throat and chest tightness with in 5 mins of receiving the vaccine
60 2021-04-05 headache, fatigue Thrush, extreme fatigue daily, severe headaches nightly, still occurring
60 2021-04-06 throat irritation My throat was itchy in between that half hour my voice started to change; my throat felt worse; I ha... Read more
My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
60 2021-04-09 headache Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along... Read more
Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along her heart, collar bone area, and ribs; Hot flash on the left side of her head preceded the headache; Headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included sickle cell anaemia diagnosed when she was a baby from an unknown date unknown if ongoing. The patients concomitant medication included unknown injectable medication the patient stated she was given injectable medication for 2 tests, 1 on 23Feb2021 and 1 on 26Feb2021. She said she didn't know the name of the medications given to her and the tests were ordered by her cardiologist. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient experienced sickle cell crisis on 18Mar2021 headache on Mar2021, she said she was unable to touch her collar bone because of the pain on an unspecified date, pain along her heart, collar bone area, and ribs on an unspecified date, hot flash on the left side of her head preceded the headache on an unspecified date. The patient was hospitalized for sickle cell crisis from 19Mar2021 to 20Mar2021. The patient was still had sickle cell crisis pain along her heart, collar bone area, and ribs. She said she was unable to touch her collar bone because of the pain. She said she also had a headache. She clarified the headache started a couple days after she had the COVID-19 Vaccine. She said a hot flash on the left side of her head preceded the headache. She said she still had a headache, and some days her headache was better. She said yesterday (24Mar2021) her headache was so strong. She said the headache was on the left and back side of her head, but particularly strong on the back side of her head. The patient went to the Emergency Room after midnight on 19Mar2021. She said she spent the night at the hospital as an inpatient, and then was discharged by Saturday (20Mar2021) afternoon, around 14:30-15:00. She said she was given Morphine for pain, and was on an IV, and took her regular medicines. She said she did not know the name of the IV fluids that were given to her. The patient underwent lab tests and procedures which included cardiac stress test and electroencephalogram result was unknown. The outcome of event hot flash on the left side of her head preceded the headache was unknown and outcome of all other events was not recovered, Information on the lot/batch number already available. Further information has been requested.
60 2021-04-09 fever, headache, chills vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urin... Read more
vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.
60 2021-04-12 headache Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional... Read more
Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient said she experienced left side numbness, slurred speech, severe neck pain, and a headache. She said she had stroke like symptoms but after being hospitalized for 3 days and having a CT scan performed stroke was ruled out.
60 2021-04-18 fatigue appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; enti... Read more
appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.
60 2021-04-18 headache, chills left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday s... Read more
left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday some had subsided but not all. tylenol of no use!
60 2021-04-20 malaise her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little ... Read more
her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.
60 2021-04-23 fever, chills Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient... Read more
Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration in the left arm on 11Feb2021 at 08:45 AM (at the age of 60-year-old) as a single dose for COVID-19 immunization at Workplace clinic. Medical history included allergies to medications, food, or other products was Sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination included citalopram at 20 mg. Patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 immunization. On 12Feb2021 at 12:00 AM, on the second day, the patient experienced chills, body aches, nausea and fever. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills, body aches, nausea and fever were recovering. No follow-up attempts are Possible. No further information can be obtained.
60 2021-04-24 pneumonia Pneumonia; This is a spontaneous report from a contactable nurse. A 60-year-old female patient recei... Read more
Pneumonia; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200) via intramuscular, administered in Arm Right on 19Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is not pregnant. No other vaccine received in four weeks. Patient experienced pneumonia after first injection on an unspecified date in 2021. Event resulted in Doctor office visit, Emergency room or urgent care, Hospitalization, Life threatening illness. Patient admitted to hospital for 5 days and received treatment. Unknown if patient had COVID prior vaccination. Unknown if COVID tested post vaccination. Outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event pneumonia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified. Linked Report(s) : US-PFIZER INC-2021423487 same patient/product, different dose and event
60 2021-04-24 chills possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like... Read more
possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.
60 2021-04-26 chills, malaise This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old fem... Read more
This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
60 2021-04-26 headache her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional ... Read more
her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.
60 2021-04-27 fatigue, headache Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and s... Read more
Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Exhaustion; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL9262) as SINGLE DOSE in left arm, dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:45 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, joint stiffness, back pain, arthralgia and unknown date, Allergic to insect stings. Concomitant medication included acetylsalicylic acid (ASPIRIN); paracetamol (TYLENOL). The patient previously took Augmentin and experienced drug allergy. On 16Feb2021 the patient experienced both times like mini version of covid which patient had a year ago. now right side of my neck hurts and still inflamed, feeling extremely fatigued, headaches, exhaustion (suspected covid-19) The outcome of both times like mini version of covid which I had a year ago, now right side of my neck hurts and still inflamed, feeling extremely fatigued. Headaches, exhaustion was not recovered.; Sender's Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL9262) to reported events is probable.
60 2021-04-27 fatigue, nasopharyngitis She had a slow infection in her chest; She was breathing fine, but she got out of breath every now a... Read more
She had a slow infection in her chest; She was breathing fine, but she got out of breath every now and then; her immune system was not too good; no sleeping; She was so tired; she woke up on Thursday (08Apr2021) sick; She had a cold all year long, but normally doesn't have a color from her chest and nose (mucus). She said she now had a color to her chest and nose mucus; Has had a bad cold after the vaccine and an infection in her lungs; She had no energy, and couldn't work; This is a spontaneous report from a contactable consumer, the patient. This 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration in the left arm on 07Apr2021 around 12:15 (at the age of 60 years-old) for COVID-19 vaccination. Medical history included smoker since 1976 pack-a-day of cigarettes since 16, quit for 11 months, she went back to smoking, x-rays done in the 1990's and the patient was told that the lower part of her lungs were flat and was told she had chronic obstructive pulmonary disease (COPD) and emphysema at that time. She said her lungs were pretty bad. Family Medical History Relevant to adverse events were not provided. Concomitant medications included ascorbic acid, rosa canna fruit (VITAMIN C PLUS NATURAL ROSE HIPS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had a slow infection in her chest on an unspecified date (also reported as her doctor told her she had a little bit of an infection), a bad cold after the vaccine and an infection in her lungs on Apr2021, she woke up on Thursday 08Apr2021 sick, was so tired on 08Apr2021, had no energy and slept for 5 hours, couldn't work on Apr2021, had a cold all year long, but normally clear drainage from her chest and nose, she now had a color to her chest and nose mucus on Apr2021, she was breathing fine, but she got out of breath every now and then on an unspecified date and her immune system was not too good on an unspecified date. She reported that on 11Apr2021 to 13Ap2021 she has been fine, no sleeping. The patient had been told by her doctors that her immune system was not too good, and she should quit smoking. She said her sister was a licensed practical nurse (LPN), and her sister told her that she thought she (the reporter) may have had a cold when she got her first COVID-19 Vaccine. She said she had felt good since Sunday (12Apr2021). She said she felt stronger, but her cold was not better. She said she was breathing fine, but she got out of breath every now and then. The patient reported that she would get a lung infection if she had a bad cold. She said her doctor told her she took way too many antibiotics in the past, and now her body was used to the antibiotics It was also reported that she said she doesn't take antibiotics. She reported that her second COVID-19 Vaccine dose was scheduled for 05May2021, which was 4 weeks after the first COVID-19 Vaccine dose. There were no relevant laboratory tests done. There were no emergency room (ER) or physician office visits. Nature Made Vitamin C 1000mg yesterday (12Apr2021). She said she was taking 1 Nature Made Vitamin C (Lot Number: 2370401, Expiration Date: Feb2024) 1000mg a day. Adverse events following prior vaccinations were not applicable. The clinical outcome of no sleep, chest infection, no energy, couldn't work, out of breath, immune system was not too good was unknown, not recovered for cold, sick, color to her chest and nose mucus and recovering for tired. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
60 2021-04-27 fever, headache, chills delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable c... Read more
delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 10:00 (at the age of 60-years-old) as single dose for COVID-19 immunisation. The patient took the first dose on 23Mar2021 at 10:00. The patient's medical history and concomitant medications were not reported. On 13Apr2021 at 22:00, about 12 hours after receiving the 2nd dose, the patient experienced chills, fever, delirium, headache, and body aches. By 35 hours after the dose, symptoms were mostly past. The patient did not have COVID prior vaccination and patient was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61 2020-12-31 headache, fever Body ache, head ache, fever, nausea, liwer leg muscle spams/cramping
61 2020-12-31 malaise, lethargy, sweating Lethargic, Diaphoresis, general unwell feeling
61 2021-01-03 throat irritation About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, ... Read more
About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation
61 2021-01-03 malaise, fatigue Extreme fatigue, weakness, lightheaded, malaise
61 2021-01-03 headache, lethargy Lethargy and headaches for 2 days
61 2021-01-03 throat pain, fever, cough, influenza like illness, nasal congestion Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, ... Read more
Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.
61 2021-01-03 respiratory tract congestion congestion in the throat and upper lungs; congestion in the throat and upper lungs; This is a sponta... Read more
congestion in the throat and upper lungs; congestion in the throat and upper lungs; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular on the left arm on 21Dec2020 09:30 at a single dose for COVID-19 immunization. The patient's medical history included herpes 2. The patient was not pregnant. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 26Dec2020 09:00, the patient experienced congestion in the throat and upper lungs. Oxygen level was 98 and temperature was 97.7. She had a good diet, no dairy, and no Christmas junk food, so for the patient, it was inexplicable. She was also consistent at mask wearing and all the precautions. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were reported as non-serious.; Sender's Comments: Considering the temporal gap between the vaccination and the event onset, the Company considers the event pulmonary congestion is unlikely related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-01-04 nasal congestion, fever, malaise, chills, cough, headache Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Satur... Read more
Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Saturday and is still experiencing all of these symptoms overall. Patient has been taking TheraFlu
61 2021-01-04 fever, chills, headache Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills... Read more
Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
61 2021-01-04 headache NAUSEA AND HEADACHE
61 2021-01-04 fever Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees a... Read more
Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees and elbows and arm pain at injection sites. This is the 2nd dose, patient reports no adverse reactions on the first dose.
61 2021-01-04 headache Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseat... Read more
Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.
61 2021-01-04 body temperature increased, fatigue, headache VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADA... Read more
VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .
61 2021-01-04 fever, chills, nasopharyngitis aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was fr... Read more
aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.
61 2021-01-05 fever, fatigue Low grade temp, body aches, fatigue
61 2021-01-05 headache couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my a... Read more
couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
61 2021-01-06 nasopharyngitis, throat pain Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; Th... Read more
Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on left arm at single dose for COVID-19 immunization on 23Dec2020 at 61-year-old. No medical history or concomitant medication. Yesterday (30Dec2020), the patient woke up with a sore throat, it was like getting cold with a sore throat, congested, the patient had cold like symptoms, seemed like the patient was getting a cold. The patient just took decongestant medication. After waking up this morning (31Dec2020) the patient did not have taken anything. The patient got tested for COVID (for antigen not a PCR) yesterday (30Dec2020) and was negative. The patient did not have got any fever, just sore arm a week ago (Dec2020). She was hurting for a day and then she was good, everything good. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.
61 2021-01-06 headache, fever, chills Fever 101.7 Chills, Body Aches, Generalized Weakness, Head Ache, Diarrhea
61 2021-01-06 chills, headache, fatigue Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction last... Read more
Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.
61 2021-01-06 headache, chills Headaches, body aches, chills, x 3 days now resolved.
61 2021-01-06 headache, fatigue Patient describes headache and dizziness, also fatigue.
61 2021-01-06 cough, throat irritation Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine... Read more
Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine. Pt stated that her throat is dry and feels a sensation to cough. Pt stated that started feeling swelling of the tongue 30 minutes after administration of the vaccine. Pt was given water and says that it helped relieve itching. Pt was given benadryl 25mg IM and is being monitored. Charge nurse is taking over monitoring and care of patient.
61 2021-01-06 fever, chills Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. C... Read more
Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. Called my manager at work. Went back to bed. Around 8am took 2 Tylenol extra strength 225 caplets, 500mg each. 3 hours later temp down to 99.2. My normal is 97.6
61 2021-01-06 headache left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the s... Read more
left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe
61 2021-01-06 productive cough, cough worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her vo... Read more
worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her voice, she felt like she was losing her voice; scary/"scaring" her; coughing/cough; difficult for her to catch her breath/lost her breath, couldn't catch her breath/couldn't breath; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date 30Apr2021) intramuscular on 29Dec2020 09:16 at 0.3 mL, single for Covid-19 immunization in a hospital. Medical history included diabetic, allergy reactions, blood pressure (abnormal), cholesterol (abnormal); all ongoing, and reaction to dust. Concomitant medications included ongoing amlodipine;hydrochlorothiazide;valsartan for blood pressure, ongoing potassium for unspecified indication, BP pills (unspecified) and has cholesterol medications. The patient informed that yesterday (29Dec2020), she got the COVID vaccine shot at work, received it at 9:16 am and was monitored for 30 minutes post administration. The patient went to work and was holding the babies. The patient worked in transport in the NICU at a hospital. Few hours after the injection, while working in the NICU, she experienced coughing to the point where it was difficult for her to catch her breath. The patient started coughing so bad, she had no control. She mentioned trying to drink water and continued coughing more. The patient lost her breath, couldn't catch her breath, she had to call for the charge nurse (manager), as she couldn't breath and they took her to the ER and consulted at the ER of her facility. The patient informed that she kept coughing and couldn't catch her breath. They made her drink water. The patient has allergies, so she always has an epi pen with her. The patient felt like she had an allergic reaction to the vaccine. The doctor there explained that her symptoms were not related the Covid-19 vaccine she received earlier. The patient specified that the last time she had a similar reaction was at work and was due to dust. The patient explained that she was perfectly fine before receiving the vaccine, laughing, and so what can her symptoms be related to, if it was not the vaccine. The patient was coughing all night, can't get rid of the cough. She has called her doctor. The nurse said just to watch herself for now. The patient informed that she was supposed to go back to work tomorrow and she was afraid to go around the babies. The patient informed that today (30Dec2020), she gargled apple cider vinegar and salt water, and phlegm came out. The patient continued saying that she has still been coughing, can't talk and that it was scary. The patient informed that she was taking her voice, she felt like she was losing her voice. It was "scaring" her. She was unsure if it was the Pfizer vaccine. The patient attempted to reach her HCP and that she cannot be seeing at her clinic due to her cough. The patient mentioned that she won't have access to a respiratory clinic until Tuesday. The patient expressed her concerned about returning to work with babies and asked if she should return to work tomorrow. The patient pursued verbalizing her worry and frustration. The patient asked if she can decide not to get the second dose. The patient voiced her regrets on receiving the first dose of the COVID-19 vaccine. She stated wishing she would have never taken it and that all who have an EpiPen should not receive it. The outcome of the event cough was not recovered, Dyspnoea, Allergy to vaccine, Productive cough, Speech disorder, Aphonia, Nervousness, Anxiety, Frustration tolerance, Depressed mood was unknown.
61 2021-01-07 fatigue 1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after... Read more
1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM
61 2021-01-07 fatigue Arthralgia fatigue Narrative:
61 2021-01-07 fatigue Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet... Read more
Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection via an unspecified route of administration on left arm on 22Dec2020 02:30 at a single dose for Covid-19 immunization. Medical history included CREST Syndrome, type 2 diabetes, osteoarthritis, allergies to Sulfa and Dermabond tape. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient took other medications in the last two weeks. On 26Dec2020, the patient experienced average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also, she experienced achiness, and tiredness on 26Dec2020. No treatment received for the events. The patient was not diagnosed with Covid-19 and has not been tested prior to vaccination. Outcome of the events was unknown. No follow-up activities are needed. No further information is expected.
61 2021-01-07 headache, chills Chills. Nausea. Headache. Body aches. Flushed face
61 2021-01-07 cough, fever, chills, fatigue, malaise Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; tem... Read more
Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; temperature 102; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer-BioNTech ;lot number: EK9231) intramuscularly at right arm on 02Jan2021 at 07:45 A.M. at a single dose (dose number: 1) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 on 07Dec2020. No known allergies (no allergies to medications, food, or other products) and no other medical history. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination were none. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included chills, temperature 102, general aches, fatigue, pain at injection site, dry cough, general malaise, no appetite. Temperature elevated till 03Jan2021, 6pm. Symptoms similar to what she experienced when diagnosed with covid-19 on 07Dec2020. All events with start date on 02Jan2021 at 06:00 P.M. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Since the vaccination, the patient had not been tested for COVID-19.
61 2021-01-07 headache, malaise Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had ... Read more
Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.
61 2021-01-07 malaise, headache Headache, Myalgia, Arthralgia, decreased appetite, general malaise, some abdominal discomfort
61 2021-01-07 headache Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a cont... Read more
Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EJ1685; expiration date: not known), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension. The patient's concomitant medications were not reported. The patient had been feeling fine after her last vaccination when she took it at a hospital on 29Dec2020 until today (01Jan2021), in which she experienced headache, nausea, vomiting, diarrhea, and she just ache all over. The patient stated it was not serious and just wanted to make sure she was not supposed to be doing something. The patient did not receive treatment for these reported events. The outcome of the events was unknown.
61 2021-01-07 nasopharyngitis, runny nose, headache, cough SEVERE HEADACHE, MILD DIZZINESS, RUNNY NOSE , EAR ACHE, STOMACH ACHE, COLDS,COUGH
61 2021-01-07 fatigue, chills, headache Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one ho... Read more
Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.
61 2021-01-07 headache Soreness Headache
61 2021-01-07 sweating, chills Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Naus... Read more
Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Nausea; Diarrhea; shivering; Sweating; Body ache; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PFL72TRA9899), intramuscular in left arm, on 31Dec2020 at 07:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (diagnosed prior to vaccination). There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 31Dec2020 at 8 PM (also reported as after exactly 12 hours; possibly discrepant), the patient experienced swollen stiff arm at the site of the injection, severe episode of nausea, diarrhea, shivering, sweating, and severe body ache. Treatment received for the adverse events included paracetamol (TYLENOL). The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
61 2021-01-07 cough, fever, fatigue, respiratory tract congestion fever 101, arm soreness, body aches, fatigue, nausea, congestion and dry cough
61 2021-01-07 headache, sweating patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral ... Read more
patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out
61 2021-01-08 headache 01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to thi... Read more
01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.
61 2021-01-08 fatigue About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left d... Read more
About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.
61 2021-01-08 body temperature increased Day 2 of 1/5/2021 vaccine, temp of 102.4 day 3, temp of 100.5 day 4 temp of 100.5 day5 temp normal
61 2021-01-08 chills, headache, fever First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next da... Read more
First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.
61 2021-01-08 fatigue, fever Low grade fever, fatigue, body aches, arm pain
61 2021-01-09 headache, fatigue Headache, nausea, body aches, joint pain, fatigue.
61 2021-01-09 chills, fever chills, fever, arm pain
61 2021-01-10 fatigue, headache, chills, fever, cough 1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER v... Read more
1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER vaccination: headache, fatigue, cough, GI distress, fever (100) 48-72 hours AFTER vaccination: headache, elevated temperature (99.7)
61 2021-01-10 headache, chills, fatigue 24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 h... Read more
24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair
61 2021-01-10 throat irritation 30 minutes s/p vaccination developed scratchy throat, no other sx VSS Transported to clinic for obse... Read more
30 minutes s/p vaccination developed scratchy throat, no other sx VSS Transported to clinic for observation
61 2021-01-10 fatigue, fever Diagnosed with COVID-19, Fatigue, Bodyaches(severe), Myalgia, Fever, Diarrhea, GI Discomfort
61 2021-01-10 headache, fever Elevated heart rate to 120, fever, shortness of breath, headache
61 2021-01-10 headache, malaise Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritabilit... Read more
Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritability, anxiousness, generalized not feeling well around 5pm day of; went to bed. Woke up at 10:30pm with headache, took Tylenol. Wednesday didn't feel well in general, left work at noon, went home to bed. Thursday felt better but not baseline self. Friday generalized not feeling well. Saturday went to ER due to feeling much worse generally, SOB. Tests Urine, blood. Everything within normal limits.
61 2021-01-10 fatigue Extreme fatigue beginning on the evening of 1/7/2021 lasting through Saturday (1/9/2021) morning.
61 2021-01-10 headache, fatigue, chills Headache (moderate to severe), chills, fatigue, muscle aches, skin sensitivity
61 2021-01-10 headache, fever Low grade fever body aches chills headache arm soreness
61 2021-01-10 chills, fever On 01/10/2021 started feeling Chills then 102.5 fever lasting 2 hours, took 2 Tylenol and fever went... Read more
On 01/10/2021 started feeling Chills then 102.5 fever lasting 2 hours, took 2 Tylenol and fever went down to normal. Later I realized that I had two swollen lymph nodes on the left side of my neck. Next morning 01/11/2021 at woke up noticed another swollen above the hollow of the clavicle.
61 2021-01-10 fatigue, headache SORE ARM,HEADACHE LOWER BACK PAIN FATIGUE
61 2021-01-10 headache Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after r... Read more
Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after receiving dose
61 2021-01-10 chills, headache, cough Sunday 1/10/2021 at 10:30 am started with chilling then body aches and headache started in the next ... Read more
Sunday 1/10/2021 at 10:30 am started with chilling then body aches and headache started in the next hour then headache. Chilling better about one hour later. Took ibuprofen at 1:15 pm and relief of aches and headaches in about 30-60 minutes. Had dry cough. Very tired all day.
61 2021-01-10 fatigue, headache injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13... Read more
injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol
61 2021-01-11 headache, fever, chills, fatigue Fever/chills 104.8, N/V, severe fatigue/weakness, severe headache, body aches
61 2021-01-11 headache, respiratory tract congestion, fever Headache, Body aches, fever, stuffy head developed 12 hours after injection
61 2021-01-11 headache, fever Headache, low grade fever
61 2021-01-11 fever, headache Headache, low grade fever.
61 2021-01-11 headache, malaise Headache, nausea, diarrhea, malaise. Improving.
61 2021-01-11 headache, fever Low grade fever, headache
61 2021-01-11 fatigue, malaise Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tir... Read more
Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (Patient) reported for a 61-year-old female patient received the first dose of BNT162b2 (lot: EK92331), intramuscular at left arm on 04Jan2021 (approximately between 18:15-18:30) at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications included supplements. The patient experienced soreness and swelling at injection site, malaise and feels tired on 05Jan2021 08:00. She was scheduled for second dose a day later for COVID vaccine so after the 21 days to get her second dose. Patient is a Dental Hygienist. She received the first dose on 04Jan2021 and is scheduled to receive second dose on 26Jan2021. She should have it scheduled for 25Jan2021. There is no prescriber. She received it at a local hospital through her employer. They did not offer her the 25Jan2020, and said next day is 26 days. They told her there would not be any problem being a day late. She called back with a concern and had evening appointment with the intention of being 3 weeks later. She did it while she had 2 days off work in case she had a reaction. She was told it was not a big deal to get it 1 days later. She asked if she could go to a different location and they told her no, it had to come from the same batch and lot to receive second dose. She is just concerned about doing it a day before she has to go back to work because there are worse side effects with second dose. There is a 4 day grace period from what she read of of 17-21 days and not over 21 days. She is not sure if that is true though. The outcome of the events was not recovered.
61 2021-01-11 respiratory tract congestion congestion; positive for Covid-19; positive for Covid-19; This is a spontaneous report from a contac... Read more
congestion; positive for Covid-19; positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (patient). A 61-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date not reported), via an unspecified route of administration on left arm on 31Dec2020 at 08:15 at a single dose for Covid-19 immunization/precaution because she works with hospice patients. Medical history included blood pressure (abnormal), diabetes, cholesterol (abnormal), and acid reflux, all are ongoing. The patient has no family medical history. Concomitant medications included amlodipine besilate, benazepril hydrochloride for blood pressure taking about 4-5 years, metformin for diabetes taking about 5 years, rosuvastatin for cholesterol Taking about 5 years, pantoprazole for acid reflux taking 5 years, and vitamin D as supplement taking for 3 years. No previous immunization nor vaccines administered on same date of the suspect drug. The patient was calling about the COVID vaccination, which she received on Thursday, 31Dec2020. Her husband tested positive on Thursday, so she took the test on Thursday after she took the vaccination and they just told her today, 04Jan2021, that she is positive for Covid-19. She wanted to know if that was going to mess up her vaccination in any way and if there are recommendations for second dose. She is a CNA. There was no prescriber. She received it because she works with hospice patients. Test was administered on 31Dec2020. COVID Test resulted on 10:00 04Jan2020 as positive. ER or physician's office required: She just went to get a COVID test when her husband tested and they gave her a azithromycin (Z-PACK) 250 mg because she had congestion. Take two tabs first day and then one daily for 4 more days. She is taking last one today (04Jan2021). Outcome of the events was unknown.; Sender's Comments: A causal association between reported events and BNT162B2 cannot be excluded.
61 2021-01-11 fever, malaise fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen aft... Read more
fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.
61 2021-01-11 chills myalgias, chills, left arm soreness, vertigo
61 2021-01-12 fever, fatigue Employee reported a fever of 101.1 and fatigue post 24 hours after second covid vaccination. Was res... Read more
Employee reported a fever of 101.1 and fatigue post 24 hours after second covid vaccination. Was resolved by the next morning with a temp of 96.8.
61 2021-01-12 fever, fatigue, chills Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills ... Read more
Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills and extreme fatigue lasted 4 hours. Low grade fever lasted 12 hours.
61 2021-01-12 chills, dehydration Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and mo... Read more
Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!
61 2021-01-12 chills, headache, fever Pfizer-BioNTech COVID-19 Vaccine EUA Chills and low grade fever (highest it got was 99.7)- started a... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Chills and low grade fever (highest it got was 99.7)- started at 11:00 p.m. on 11/12/21. Not able to sleep in the night, headache started sometime in the night. Fever and chills were gone by morning. Headache resolved about 5:00 p.m. on 1/13/21.
61 2021-01-12 fatigue Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias o... Read more
Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.
61 2021-01-12 chills, body temperature increased, sleepiness, fatigue Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant bod... Read more
Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant body aches & pain. The next day, 1-13-21, Temp 100.4, continued body aches, very tired & sleepy. Sore right arm, body aches from head to toe. Taking Motrin again.
61 2021-01-13 influenza like illness About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I ... Read more
About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I also started feeling lightheaded like I might faint. I pull over into a parking lot and had a family member come get me to drive me home. I was extremely thirsty and drank a lot of water at home. Eventually, my redness went away and my face did not feel as hot. I did feel other more typical symptoms too such as painful arm, and flu like symptoms. I am mainly concerned about the reaction I had when driving home since it was similar to what happens when I take cortisone or Doxycycline. I am needing information as to whether it is safe for me to take my second dose of the covid vaccine.
61 2021-01-13 fatigue At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed a... Read more
At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.
61 2021-01-13 fever, headache, chills, fatigue Fever to 102 F. Chills. Total body aches. Severe headache. Nausea. All began around midnight, 1... Read more
Fever to 102 F. Chills. Total body aches. Severe headache. Nausea. All began around midnight, 16 hours post-shot. Worsened throughout the night and began to diminish about 8 hours later. After about 12 hours had only slight fever, more manageable headache, was achy all over and fatigued. Back to baseline 36 hours after onset of symptoms.
61 2021-01-13 fever Fever, muscle weakness, muscle pain
61 2021-01-13 headache Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at ... Read more
Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days
61 2021-01-13 headache, fatigue, chills, malaise Moderate to severe fatigue, headache, fever, chills, malaise
61 2021-01-13 headache, chills, fatigue, fever Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at mid... Read more
Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today
61 2021-01-13 headache, fatigue, chills Short term memory loss, Severe fatigue, Chills, Mild HA, Depression - lasted 5 hours and was gone.
61 2021-01-13 nasopharyngitis, chills, fever chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-... Read more
chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable consumer (patient herself) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Patient had a history of COVID in Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID) (for twenty some years), bupropion hydrochloride (WELLBUTRIN) (for about a year), naltrexone (for about a year), all from an unspecified date and ongoing. The patient got the vaccine yesterday (06Jan2021). Patient experienced chills, body aches, cold, fever, and pain at the injection site started at 10 am on 07Jan2021. The fever has went up a little since this morning, but everything else has stayed the same. Her fever was 100.6 degrees Fahrenheit now. Earlier this morning it was 99.3 degrees Fahrenheit. Outcome of events were not recovered.
61 2021-01-14 chills Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating... Read more
Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating. Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020. The outcome of events was recovered on 08Jan2021.
61 2021-01-14 fatigue, headache DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/... Read more
DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/10/21.
61 2021-01-14 chills, fever, headache Feeling cold, headache, chills, tender arm, fever
61 2021-01-14 throat irritation Felt a little light headed and my throat was scratched
61 2021-01-14 fatigue Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on... Read more
Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.
61 2021-01-14 body temperature increased, headache Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at inje... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.
61 2021-01-14 fatigue, fever, headache, chills Received Covid vaccine on 01/12/21. Late that afternoon, developed fever, chills, headache, body ac... Read more
Received Covid vaccine on 01/12/21. Late that afternoon, developed fever, chills, headache, body aches, and fatigue, lasted throughout the day on 01/13/21.
61 2021-01-14 headache but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then... Read more
but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown. Information on the lot/batch number has been requested.
61 2021-01-16 fatigue, headache, fever "Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.
61 2021-01-16 fever Fever of 100.4. Ibuprofen used. Went to bed/slept. Temperature normal (97.3) in am.
61 2021-01-17 headache, chills, fever, chills, fever, headache 12-14 hours after my second vaccine I had severe chills, body aches, headache, and felt feverish. Th... Read more
12-14 hours after my second vaccine I had severe chills, body aches, headache, and felt feverish. This was only partially mitigated by acetaminophen and ibuprofen. It lasted until about 42 hours post vaccine.
61 2021-01-17 headache Dizziness and headache on 1/18
61 2021-01-17 headache Headache/headache got worse and worse; This is a spontaneous report from a contactable consumer (pat... Read more
Headache/headache got worse and worse; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and co-worker). This is the first of two reports. A 61-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EJ1686, expiry date: unknown), intramuscular, on 06Jan2021 13:30 at a single dose on left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was also reported that she received the vaccine at a military facility. There were no additional vaccines administered on same date of bnt162b2. Medical history included high blood pressure diagnosed about a month ago (Dec2020) and ongoing, and glaucoma from an unspecified date (diagnosed when she was 15 years old) and ongoing. Concomitant medications included losartan (Manufacturer: Lupin, 50 mg tablet) for high blood pressure, venlafaxine ER (Manufacturer: Aurobindo, 150 mg Prolonged-release capsule) as anti-depressant, latanoprost (Manufacturer: Sandoz, 0.005 %) for glaucoma, and brimonidine tartrate, timolol maleate (COMBIGAN, Manufacturer: Allergan) for glaucoma; all were from unspecified dates and ongoing. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EH9699), intramuscular, on 19Dec2020 at a single dose on left arm for COVID-19 immunization; there was no adverse event following this vaccination. The patient experienced headache on 06Jan2021 at 11:45 am (As reported, pending clarification). The patient reported that she did not have anything with the first dose. She got the second dose of the Pfizer Covid Vaccine on 06Jan2021 at 13:30. She started getting headache at 11:45 am (as reported) but she didn't think much of it. On 07Jan2021, she had a headache and she took two Tylenol and then went to sleep. She woke up around midnight that night and her headache got a little bit worse, so she took two Tylenol again and fell asleep. In the morning of 08Jan2021, around 2:30 am her headache got worse and worse, and she took three Tylenol. Her headache was still there but it was not enough to go to the emergency room or anything. She panicked on Thursday (07Jan2021) since her headache was still there; her headache was still lingering but it was going away. Her headache pain was at 7 out of 10 on an unspecified date. She stated that she was supposed to work at the time of report, but she called out of work due to her headache. Therapeutic measures were taken as a result of the headache and included treatment with Tylenol 500 mg (lot number: DFE3060A, expiration date: Apr2022). The adverse event did not require a visit to Emergency Room or Physician office. Outcome of the event was recovering.
61 2021-01-17 chills, headache Headaches, Chills, worst nausea and abdominal pain I?ve ever had in my life, vomiting
61 2021-01-17 headache Nausea & Headache
61 2021-01-17 body temperature increased Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a ... Read more
Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.
61 2021-01-17 nasopharyngitis, headache Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left... Read more
Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.
61 2021-01-17 chills, fatigue i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 ... Read more
i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 woke up feeling a little tired, went to work. went home early at 1:30 pm, feeling a little chilly. no fever. 1/15/21 in the morning noted pain on Left armpit ( injection site is left arm), pain from left shoulder blade to right shoulder blade. took advil. In the afternoon, about 4:00 pm, noted some swelling and soreness on left armpit. took Advil.. 1/16/21, Called employee health to report this. Advised to take advil and monitor and call pcp if symptoms persists.
61 2021-01-18 headache, fatigue, fever 24 hours after my 2nd vaccine I had symptoms of severe fatigue and body aches. I had a low grade fev... Read more
24 hours after my 2nd vaccine I had symptoms of severe fatigue and body aches. I had a low grade fever and headache. The following morning I had pain in my left axilla, low grade fever, headache and body aches. I left work early because of severe fatigue and was out the following day for symptoms due to covid vaccine.
61 2021-01-18 chills Chills, swelling, warm to touch , redness on the right arm inject site area and very itching
61 2021-01-18 cough, headache, influenza like illness, fever Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches... Read more
Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events. The outcome of the events was unknown.
61 2021-01-18 fatigue, headache DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 TH... Read more
DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 THRU 01/19 SORE ARM 01/09 THRU 01/19
61 2021-01-18 headache, influenza like illness, fever, chills, fatigue Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal head... Read more
Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
61 2021-01-18 body temperature increased Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minute... Read more
Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minutes at a time for next 24 hours. O2 saturation went down as low as 91 but mostly was at 93, heart rate 112 on Jan 13, along with a 100.1 oral temp. I did not Check on Jan 12. Morning of Jan 14: 99 oral temp and 95 O2 saturation. By evening temp and O2 were back to normal: 98° and 98%. Jan 17 I experienced some wheezing. I did have COVID with pneumonia Sept 2020.
61 2021-01-18 throat irritation Systemic: 6 hours after vaccine lost voice, 8 hours after mouth, tongue, throat itching. next morni... Read more
Systemic: 6 hours after vaccine lost voice, 8 hours after mouth, tongue, throat itching. next morning had face and lip swelling and tingling. self treated with antihistamines. resolved after 3 days.
61 2021-01-18 chills, malaise, cough, throat pain chills shakes nausea vomiting cough sob sore throat maliase
61 2021-01-18 cough, chills, fever, headache, fatigue fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous r... Read more
fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the left arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Relevant medical history included diabetes type 2, high blood pressure, hyperlipidemia, and glaucoma. Concomitant medications included orphenadrine (K-FLEX), empagliflozin (JARDIANCE), losartan, atorvastatin calcium (LIPITOR), and insulin. The previously took metformin and experienced allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 18:00, the patient experienced fatigue, headache, body aches, chills, cough, gastrointestinal (GI) distress, and high fever (102). The patient did not receive treatment for the events. Outcome of the events was recovering. Information on the lot/batch number has been requested.
61 2021-01-18 fatigue itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swellin... Read more
itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.
61 2021-01-18 headache itchy rash on bilateral elbows, headache
61 2021-01-18 fatigue, malaise vertigo, fatigue, malaise
61 2021-01-19 fatigue, headache After getting this vaccine I start feeling dizzy, headache, fatigue, tachycardia and body aches
61 2021-01-19 fatigue, chills, sneezing, headache Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot. Sneezing, achi... Read more
Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot. Sneezing, aching in joints., headache, chills with second shot.
61 2021-01-19 malaise, chills I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a wa... Read more
I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.
61 2021-01-19 fatigue, headache Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could bar... Read more
Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination
61 2021-01-19 body temperature increased, headache Larm pain, low grade temp to 100.2, mild headache
61 2021-01-19 fever, headache, fatigue, runny nose Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours... Read more
Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.
61 2021-01-19 fatigue, chills, head discomfort Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic... Read more
Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.
61 2021-01-19 nasal congestion, fatigue Tingling in left face check..legs very weak .. congestion..very tired for 4 days
61 2021-01-19 headache, fatigue, chills, fever mild tingling of lips after injection - within 1st hour. Fever- up to 101.6 degrees- noticable aft... Read more
mild tingling of lips after injection - within 1st hour. Fever- up to 101.6 degrees- noticable after 15 hours of the vaccine Chills- off and on after about 15 hours of vaccine Body aches and pains/ fatigue Headache- severe
61 2021-01-20 chills, body temperature increased Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6... Read more
Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6 to touch and on abduction. About 11 hours after vaccination, I became increasingly uncomfortable, feeling warm, chills, muscle aches. I could not sleep. 22 hours after vaccination, my temperature was 101 F (did not take it before this time). Temperature waxed on waned from that point (day #2). About 36 hours after the vaccine, my temperature stabilized to normal. 48 hours after the vaccine, I felt better and better with each hour.
61 2021-01-20 chills, body temperature increased, fatigue, lethargy Around 7:30 PM I arrived home from work and started feeling very lethargic, extremely tired. Around ... Read more
Around 7:30 PM I arrived home from work and started feeling very lethargic, extremely tired. Around 3 AM I started running a temperature (100.5F) and started with the chills and body aches. I still feel very tired.
61 2021-01-20 fever Day after 2nd vaccine, developed chills, fever of 99.4, and overall body aches
61 2021-01-20 fever, chills, headache Diarrhea about 6hrs after injection chills fever body aches and dull headache continued for about a... Read more
Diarrhea about 6hrs after injection chills fever body aches and dull headache continued for about another 24 hrs
61 2021-01-20 fatigue, malaise Extremely tired dizzy feeling of vomiting upset stomach
61 2021-01-20 fever, chills Global myalgia, chills, high fever, significant arm pain. Excedrin used. Symptoms mostly resolved.
61 2021-01-20 fever Resident with fever of 102
61 2021-01-20 chills, fever, headache The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint... Read more
The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint hurting and headache. It was not like I could not work or anything, it was just there. On the 9th day I woke up with fever and chills and a super bad headache and I felt so bad I could not even go seek medical care, I finally went after 3 or 4 days feeling like that. At the walk in clinic they tested me for flu, covid and strep and on the rapid the result was negative but when done the PCR it came back positive (around 12/29/20). I did not have any respiratory issues on this one. I do remember having diarrhea.
61 2021-01-20 fatigue felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fati... Read more
felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."
61 2021-01-20 chills sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneo... Read more
sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneous report from a non-contactable nurse reported for herself. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular in the left arm on 08Jan2021 12:00 at single dose for Covid-19 immunization in a hospital. Medical history included COPD, hypothyroidism and allergies to penicillin (PCN). The patient was not pregnant. The patient has no COVID prior vaccination. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), montelukast sodium (SINGULAIR), oxybutynin, and azelastine; all from unspecified date for unspecified indication. The patient previously took Celebrex and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular in the left arm on 20Dec2020 09:15 (61 years old) at single dose for Covid-19 immunization in a hospital. The patient has no other vaccine in four weeks. On 08Jan2021 15:45, the patient experienced sensitivity to cold, or feeling chilled for 48 hours post dose, short of breath (SOB) with minimal exertion for 72 hours post dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not received treatment due to the events. The outcome of the events sensitivity to cold, or feeling chilled, short of breath (SOB) with minimal exertion was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
61 2021-01-21 fatigue Extremely tired and exhausted for about 24 hours. Treatment as sleep and rest
61 2021-01-21 throat pain, headache, body temperature increased Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, ... Read more
Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic
61 2021-01-21 headache Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30... Read more
Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30 pm. Took zofran
61 2021-01-21 fatigue, chills I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs fe... Read more
I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.
61 2021-01-21 headache, chills Itching, headache, chills
61 2021-01-21 chills Palpitations with elevated heart rate and some chills.
61 2021-01-21 fever, headache SEVERE HEADACHE, BODY ACHES, LOW GRADE TEMP (99-100) LASTED ABOUT 24 HRS. TOOK EXTRA STRENGTH TYLENO... Read more
SEVERE HEADACHE, BODY ACHES, LOW GRADE TEMP (99-100) LASTED ABOUT 24 HRS. TOOK EXTRA STRENGTH TYLENOL Q 4 H
61 2021-01-21 headache, fatigue received 2nd pfiser covid vaccine and had body aches, tiredness and headache for 36 hours. started ... Read more
received 2nd pfiser covid vaccine and had body aches, tiredness and headache for 36 hours. started 12 hours after vaccine
61 2021-01-22 headache, body temperature increased Temperature of 101 degrees, headache
61 2021-01-23 headache Severe base of neck and frontal head pain. Unable to sleep. Lasted x 2 days; 01-18 & 01-19-21.
61 2021-01-24 headache, body temperature increased 12 hours after shot Headache, stomach upset, fever 100.6, body aches x 36 hours
61 2021-01-24 chills, fever Chills. Fever. Nausea. Vomiting. Fainted
61 2021-01-24 lethargy, headache Extremely lethargic Swelling in vaccinated arm Pain in vaccinated arm Body aches Headache Congesti... Read more
Extremely lethargic Swelling in vaccinated arm Pain in vaccinated arm Body aches Headache Congestion
61 2021-01-24 malaise Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfor... Read more
Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
61 2021-01-25 headache Headache, nausea
61 2021-01-25 headache, malaise No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache... Read more
No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.
61 2021-01-25 cough Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 1... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 11 pm to use the restroom and when I returned to bed I had a cough and SOB. This continued with copious secretions with worsening over time until I was fighting for air at 4:30 am. My husband called the ambulance because he did not feel he could get me to the hospital in time. In the ambulance I was started on 4L of O2. Upon arrival at the ER I was given a breathing treatment and started on the BiPap. I was admitted to the hospital and received 3 more breathing treatments and recovered to be on room air by 11:00 pm. The tests and observations, the doctor reported that there was no other cause than the vaccine.
61 2021-01-25 headache, malaise, sleepiness not sure if it is covid; feeling unwell; headache; dizzy; sleep the whole day/ falling asleep; This ... Read more
not sure if it is covid; feeling unwell; headache; dizzy; sleep the whole day/ falling asleep; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as Pfizer Covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 04Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose of the Covid vaccine on 04Jan2021. She stated that the first day it was okay but on the second day, she slept the whole day and even when standing up cooking, she was falling asleep and on the third day, she was completely okay. After that day, she was okay until now. She was now feeling unwell, headache (she never gets a headache like this before, a really, really headache) and dizzy (all starting yesterday). She takes Tylenol and will be okay for 8 hours. She further reported that she did not have a fever. She added that on Sunday, she was dizzy and has an on and off headache but not all the time and also for today too. She is not sure if this is a side effect or if it is covid. She inquired if these are side effects or does she need a Covid testing. The outcome of the events was unknown. The following information on the batch/lot number has been requested.
61 2021-01-26 chills, headache AT VACCINE SITE R ARM - REDNESS, SLIGHTLY SWOLLEN, TENDER. ALSO C/O H/A SINCE 1500 1/26/21. NOTED CH... Read more
AT VACCINE SITE R ARM - REDNESS, SLIGHTLY SWOLLEN, TENDER. ALSO C/O H/A SINCE 1500 1/26/21. NOTED CHILLS 1/26/21 PM ALSO
61 2021-01-26 chills, fatigue Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, sl... Read more
Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.
61 2021-01-26 fever, chills Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold flu... Read more
Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold fluids down, "metal taste"--by day 9 went from 103 kg to 92 kg. Slowly got better after this with time and Pepto Bismol.
61 2021-01-26 sweating During 15 min observation after receiving vaccine, patient reported tingling in lips and diaphoresis... Read more
During 15 min observation after receiving vaccine, patient reported tingling in lips and diaphoresis. Patient was administered diphenhydramine 50 mg PO while in vaccine clinic, rapid response was called and patient was transported to the ED. Patient was administered famotidine 40 mg PO and prednisone 50 mg PO and released from ED 5 hrs later.
61 2021-01-26 fatigue, headache Headache 1st day Day 2/3 severe body aches, muscle and joint pain, fatigue, brain fog, insomnia
61 2021-01-26 fever felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; Th... Read more
felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; This is a spontaneous report from a contactable consumer report self. This 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL4176), via an unspecified route of administration at left arm on 12Jan2021 14:30 at single dose for covid-19 immunization. Medical history included COVID in Nov2020 (Patient was tested for Covid on 23Nov2020 and found out the 25Nov2020 the result was positive), she just quarantined herself at a hotel (They gave her Benzonatate, but she was also taking Tylenol 500mg and Robitussin DM). Concomitant medications not reported. Patient did not get any other shots or 4 weeks prior. No problems with vaccines in past that she can remember. No additional vaccines administered on same date of the Pfizer suspect. Patient received the Pfizer BioNtech vaccine on 12Jan2021 and after that on 12Jan2021 night she didn't feel anything but mild pain in arm, it was so painful, but not as bad on 13Jan2021 even though she still has it. She can't move her arm up and down. On 13Jan2021 morning at dawn she had a fever and it is now 101.2. Has taken Tylenol 500mg (Lot number: SLA071, UPC number: 30047112, Expiry Date: Aug2024). Patient had body aches started 12Jan2021 at midnight (12:00) that is start date of 13Jan2021. She felt cold and chilly and not sure if it was the weather or her. No Emergency Room or Physician Office visit. The outcome of "felt cold and chilly" was unknown, of else events was not recovered.
61 2021-01-26 chills, headache headache, shakiness, chills, lightheadedness
61 2021-01-26 sweating, chills, fatigue unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffnes... Read more
unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-01-27 fatigue, throat pain, headache, body temperature increased A day after getting the vaccine, had fatigue, body ache, headache, fever of 101, sore throat, bitter... Read more
A day after getting the vaccine, had fatigue, body ache, headache, fever of 101, sore throat, bitter taste, dizziness.
61 2021-01-27 fatigue, body temperature increased, headache A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headac... Read more
A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.
61 2021-01-27 chills, influenza like illness, fever, fatigue FEVER, CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMT... Read more
FEVER, CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMTPOMS RESOLVED
61 2021-01-27 headache, chills, fever Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contact... Read more
Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.
61 2021-01-27 headache Severe headache 15 hours after getting second COVID vaccine. Relieved partially with acetaminophen.... Read more
Severe headache 15 hours after getting second COVID vaccine. Relieved partially with acetaminophen. Dull headache second day. Headaches are very unusual for me.
61 2021-01-27 headache headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer ... Read more
headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.
61 2021-01-27 sweating, fatigue tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe naus... Read more
tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.
61 2021-01-28 chills, fever Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol ... Read more
Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol for relief. still feeling weak. can't stand up long without feeling dizzy.
61 2021-01-28 headache Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/mu... Read more
Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck; Muscle pain; muscles in my neck are all tied up between my shoulder blades, my shoulders all was shrugging and I could never release the muscles back that is what I felt like.; Could never release the muscles back that is what I felt like/My muscles never acted this way; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Nurse reported that she had severe side effects but not an allergic reaction. She had the vaccine on Thursday (31Dec2020) and by Sunday (02Jan2021), she had a horrible headache, all the muscles in her shoulders and back were tightened up. And all the week long, she kept trying to keep care with hot packs and cold packs and Advil and Maxalt and all kind of things but could not. Yesterday morning (as reported), she lifted nothing heavy, did nothing different at all and she could not pick her head up. Patient had to seek for medical attention just at her doctor's office not at the hospital. She had to have somebody and take care of muscle pain. She still have the muscle pain she do have to go back but they did give a muscle relaxant. Patient reported that she never had a reaction ever like this. Nurse further stated that she didn't do anything as a precursor before the vaccine or after the vaccine. The muscles in her neck were all tied up between her shoulder blades, and her shoulders all was shrugging and could never release the muscles back that was what she felt like. Nurse stated that she just have to take the second shot, that was just the first one. Somebody told her that she have to report it because it took her off the work for two days. And her muscles were still tight and at all the way to my neck and still have headache. She had a shot on 31Dec2020, and symptoms started on the 2nd. Patient reported that she never had such kind of pain before and her muscles never acted this way. She was advised by her healthcare provider that there were side effects and this one she consider severe. She was advised to continue to take the second one. Outcome of the events headache/could not pick my head up and all the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck were not recovered; outcome of the rest of events was unknown. Information on the Lot/Batch number has been requested.
61 2021-01-28 fatigue This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (n... Read more
This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3294 and Expiration Date unknown) via an unspecified route of administration on 11Jan2021 07:15 AM (Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 03:45 PM (Left arm) at single dose for COVID-19 immunisation.No covid prior vaccination, no covid tested post vaccination and no known allergies.Other medical history included thyroiditis and scleritis The concomitant medications included Levothyroxine, Vitamins, paracetamol (TYLENOL), Pepsid, Melatonin. No other vaccine in four weeks. Patient experienced, fatigue, left under eye bruise, right eye injection, joint swelling, gum bleeding with brushing on 13Jan2021 08:00 AM, resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with unknown treatment.
61 2021-01-29 chills Numbness around my mouth, chills, and nausea
61 2021-01-29 headache, fatigue alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves ... Read more
alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.
61 2021-01-30 chills, headache Bad headache Tight chest Shortness of breath Chills
61 2021-01-31 fatigue, malaise, nasopharyngitis, headache, body temperature increased (This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she ... Read more
(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.
61 2021-01-31 chills Chills & Vomiting
61 2021-01-31 chills, headache, malaise Headache, Chills, Nausea, Diarrhea, Malaise
61 2021-01-31 headache Patient's reaction(s) noted during COVID vaccine observation period: At 1700, patient had left obs... Read more
Patient's reaction(s) noted during COVID vaccine observation period: At 1700, patient had left observation area, gotten to car, drove away but returned because she was experiencing nausea and headache. Patient was seated, used wet cloth to forehead and back of neck. VS: B/P 127/86, HR 98, O2 sat 98%, Temp 98.0. At 1715 VS: B/P 124/76, HR 88, O2 sat 98%, temp 98.1. At 1730 VS: B/P 121/91, Hr 86, O2 sat 98%,. Still c/o headache, refused tylenol. Nausea still present but slightly improved. Reassured by staff and husband and taking sips of Sprite 1745 B/P 118/64, HR 85, )2 sat 98%, nausea improving still has H/A, states these symptoms have occurred in past with other events. 1800 B/P 117/69, HR 89, O2 sat 98%. Was walked out to car, denies lightheadedness or shortness of breath. States other symptoms are improving. Disposition: Declined going to ED. Left to go home with no further concerns.
61 2021-01-31 fever, headache Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness... Read more
Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.
61 2021-01-31 headache Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHI... Read more
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHING-Medium
61 2021-01-31 chills, fever, fatigue exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous repor... Read more
exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 10Jan2021 at 15:30 on her left arm at a single dose for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing and known penicillin (PCN) allergy. There were no concomitant medications. The patient previously took erythromycin and clindamycin and experienced allergies. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm on 20Dec2020 at 03:30 PM. The patient experienced chills, feeling feverish, aching left arm at injection site and exhaustion on 15Jan2021 at 16:45. On 16Jan2021, consumer stated, "I recently had the COVID vaccine and it was last Sunday. Is that possible to have a reaction 5 days out?" There was no treatment received for the events. The outcome of the events was not recovered.
61 2021-01-31 headache headache in the frontal lobe nausea diarrhea dizzy
61 2021-02-01 chills, headache, fever Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hur... Read more
Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis. The patient medical history was not reported. There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.
61 2021-02-01 fever, headache, chills lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back ... Read more
lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.
61 2021-02-01 fever, sneezing, headache, chills sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache;... Read more
sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache; arm hurts; The initial case was missing the following minimum criteria- No Adverse Effect. Upon receipt of follow-up information on 19Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided - "has not received information card "), via an unspecified route of administration on 17Jan2021 at single dose on the left arm for COVID-19 immunization (reported as "Why was the patient taking Covid-19 vaccine (Verbatim): works in a group home "). Medical history included ongoing heart murmur since 2019. There were no concomitant medications. There were no investigation assessment. The patient experienced low-grade fever, chills and a bad headache on 17Jan2021. Patient was sluggish and wanting to sleep all day on 18Jan2021. Patient took Tylenol for a headache. It did not work so she took sumatriptan. The patient was also sneezing on 18Jan2021. Patient reported that she sweated the fever out. She had chills at night. The headache was lingering off and on but was mild. She sneezed all day on Monday (18Jan2021). She has not sneezed yet today but she has a stuffy head on 18Jan2021. Patient clarified that she took Acetaminophen Rapid Pain Relief instead of Tylenol. She took two 500mg tablets (UPC: 3225152303, Lot: 91670159AA, Expiry: Aug2022). Patient also reported that her arm hurts on 17Jan2021. She was unable to provide the Lot number. She will receive the information card after she receives the second dose. She had a picture of the card but it was not very clear. Outcome of the events arm hurts, headache, stuffy head was recovering (also reported as ongoing), for chills, low grade fever was recovered on 18Jan2021, for sluggish and wanting to sleep all day was recovered on 19Jan2021 while for other event was unknown. Information about batch/lot number has been requested.
61 2021-02-01 chills, fever, headache very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; hea... Read more
very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.
61 2021-02-02 headache She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision ... Read more
She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision in right eye; Hole in her retina; Bad headache for 3 days; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported similar events for 2 patients. This is 1st of 2 report. A 61-year-old female consumer (patient) received 2nd dose of BNT162B2 (Covid Vaccine, lot number: EL1248) on 06Jan2021 at single dose in the right arm for COVID-19 immunisation. Medical history was not reported. Concomitant drug included Multivitamin, Vitamin C, Vitamin D Zinc all from Mar2020 and ongoing. Historical Vaccine was 1st dose of BNT162B2 (Batch/lot number: EK5730) on 18Dec2020 in the right arm. Patient got COVID vaccine and a few hours later or the next day she started getting a hole in her retina and started losing her site in right eye. she went to the doctor as she has a hole in her retina. Again, this may be totally unrelated but she wanted to call and get this reported. She is going to see a retinal specialist this afternoon. After she had her COVID vaccine she had a bad headache for 3 days. She wore sunglasses in her house because the light bothered her eyes. She noticed this on 16Jan2021 because she was looking at paperwork and her eyes felt dry. She blinked a few times and had opened one eye alone, and she noticed that her left eye was fine but the vision in her right was not. This could have been going on longer. She just never closes only one eye. When both are open, her vision is normal. She saw the eye doctor yesterday, and that is when they said she had a hole in her retina. They said she will have to have surgery to close the hole. She knows she is at the right age for this to spontaneously happen, but just in case it is related, she wanted to report it. Outcome of the event Loss of vision in right eye was Not Recovered, for headache was recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046804 same reporter, AE and drug, different patient
61 2021-02-03 sleepiness, throat irritation 12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation... Read more
12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation. Interpreter RN assisted with interpreting. Another RN assessed pt, negative wheezing &/or stridor, pt accepted bottle of water ingested/tolerated sips of water. Pt ambulated with RN w/o issue to have IM Benadryl 50 mg Right gluteus. Pt tolerated well. Pt prior hx allergies to PCN & NSAID?s w/side effects of laryngeal edema. 12:55 pm called over to pt, RN for 61 yo F with hx of laryngeal edema with PCN & NSAID?s. Pt states her throat feels scratchy, primary Spanish speaking w/interpreter at side. Assess pt no ins/exp wheezing. No stridor, no SOB on O/A 98% O2 sat, HR 67, with 90 SBP palp. Pt also, hx of anxiety. Pt given bottle of water with sips occasional clearing throat. No mouth/oral swelling visualized, however pt is requesting Benadryl. Pt does not have Benadryl on her & discussed with option of IM injection if pt feels she needs it. Pt not flushing, talking with staff & continues with no stridor. Pt again states she would like to have Benadryl. 1300 Per standing order with pt?s stated feels like her throat is having swelling/itching Benadryl 50 mg IM R gluteal with band aid applied. 1305 Per adm ALS called for f/u, pt continues with no distress, no stridor, no ins/exp wheezing. Pt sips on water & is talking with staff without distress. 1308 ALS on scene with update status, PMH & allergies with Benadryl 50 mg given @ 1300 IM, HR 67, O2 sat 98% RH, B/P 161/80 RA. Pt not in distress & is stating she feels much better, no throat swelling, just feels sleepy. Pt has husband in personal vehicle to assist pt home. Pt denies need for transport. 1323 Pt sitting in chair, calm & no distress, cont. to re-assess. 1330 Pt tolerated well & cleared for discharge to home with husband. Pt I/S to f/u with PCP if needed. Any SOB, increased anxiety d/t possible reaction, call 911 & will be re-evaluated. Pt consents to go home with husband driving.
61 2021-02-03 headache 61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after... Read more
61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after receiving first dose of Covid vaccine, began to feel lightheadedness 15 minutes later. Patient reports that she started off with a right-sided headache, and when she went to stand up took 2-3 steps forward and fell lightheaded, and and sat back in her chair. Denies loss of consciousness, chest pain, shortness of breath. Denies alleviating or exacerbating factors. Patient reports that they taken her blood pressure after symptoms, was found to be elevated, 200/100 systolic. Patient denies previous history of blood pressure medications. Denies previous reactions to vaccines
61 2021-02-03 chills, headache, fatigue Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable ... Read more
Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable other HCP reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: p9231), via an unspecified route of administration at the age of 61-years, on 22Jan2021 17:00 (05:00 PM) at single dose in left arm for COVID-19 immunization, in hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had slight headache on 23Jan2021 and was very body tired. On 24Jan2021 10:00 AM, she had diarrhea and chills. No treatment received for the adverse events. The events were considered as non-serious. Outcome of the events was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.
61 2021-02-03 headache Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack an... Read more
Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack and then gone completely after 10 minutes)
61 2021-02-04 chills BODY ACHES, CHILLS, JOINT PAIN, ARM SORENESS
61 2021-02-04 headache Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tong... Read more
Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tongue swelling
61 2021-02-04 sweating, chills I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:3... Read more
I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:30 AM on 2/5/21, I passed out three times after rising from the toilet, resulting in a split lip. I was covered with sweat the third time I "came to" and soon got the chills.
61 2021-02-04 fatigue, headache, nasal congestion Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache a... Read more
Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache and muscle aches the next day on 1/22/21. Some fatigue and nasal congestion that next day as well. Some fatigue and headache on 1/23/21. Took Tylenol once on 1/22 and 1/23.
61 2021-02-04 fatigue Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, diz... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.
61 2021-02-04 chills, fever Symptoms - ? Patient reports at approximately 02:00 she woke up with body aches, chills and fever (T... Read more
Symptoms - ? Patient reports at approximately 02:00 she woke up with body aches, chills and fever (Tmax 102.1), Tylenol taken at 05:00, at time of call temp 101. Patient denies COVID-19 exposure without proper PPE and denies travel. Patient next scheduled to work tmw morning. Last day of work and shift - ?Tuesday (2/2) Home remedies? - Tylenol at 05:00 Any improvement? - mild Recommendation? Patient educated to continue to monitor symptoms at home and to take ibuprofen and Tylenol as directed in Medical Directive and to increase fluid intake. Patient educated to manage her symptoms and to adhere to the Workplace Policy. Patient verbalized back understanding and denied further questions at this time.
61 2021-02-04 chills, fever Symptoms - ?Patient reports at approximately 02:00 she woke up with body aches, chills and fever (Tm... Read more
Symptoms - ?Patient reports at approximately 02:00 she woke up with body aches, chills and fever (Tmax 102.1), Tylenol taken at 05:00, at time of call temp 101. Patient denies COVID-19 exposure without proper PPE and denies travel. Patient next scheduled to work tmw morning. Last day of work and shift - ?Tuesday (2/2) Home remedies? - Tylenol at 05:00 Any improvement? - mild Recommendation? Patient educated to continue to monitor symptoms at home and to take ibuprofen and Tylenol as directed in the paperwork and to increase fluid intake. Patient educated to manage her symptoms and to adhere to the Illness in the Workplace Policy. Patient verbalized back understanding and denied further questions at this time.
61 2021-02-04 fatigue, headache feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was ... Read more
feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.
61 2021-02-04 fever had been running a temperature of 99.5 to 101; This is a spontaneous report from a contactable consu... Read more
had been running a temperature of 99.5 to 101; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female non-pregnant patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 3249 and expiry date unknown) via unspecified route of administration at the left arm on 11Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. The patient has no covid prior vaccination. Concomitant medication included losartan and vitamin; both from unspecified date for unspecified indication. The patient previously took vancomycin and Keftab; both experienced allergies. The patient had no other vaccine in four weeks. The patient had been running a temperature of 99.5 to 101 since Monday 11Jan2021 during the night (also reported as 11Jan2021 12:00 AM). The patient was not covid tested post vaccination. The patient did not receive treatment due to the event. The outcome of the event had been running a temperature of 99.5 to 101 was not recovered.
61 2021-02-04 cough, fever, fatigue, headache, nasal congestion, throat pain, chills sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all da... Read more
sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all day; congestion; severe headache; severe cough; achy/was in such pain all over; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), intramuscular on 18Jan2021 12:00 at single dose (left arm) for COVID-19 immunization. Medical history included slight hypertension and allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included losartan. The patient took first dose of bnt162b2 on 28Dec2020, at 10:00 (lot EL1284) at left arm for COVID-19 immunization. When the patient went to bed that night about 10 hours after the shot, I was just achy on 18Jan2021, at 22:30. When she got up at 02:30, she was in such pain all over and had chills and was hot with a slight fever, was dizzy, and tired on 19Jan2021. When she woke up later and had to call off, she had all of that (worsening), plus congestion and severe headache on 19Jan2021. The patient slept all day, but developed a severe cough by that night and she took nighttime cold medication to sleep and when she woke up on Wednesday, she took the daytime ones. The patient reported that she still have achiness, was tired, and a sore throat and some cough on Thursday, 21Jan2021. The patient received therapy for the event severe cough; and patient did not received treatment for the rest of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovering.
61 2021-02-05 headache, fatigue, body temperature increased Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad he... Read more
Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad headache started while driving home. Took Tylenol but 24 hours later still have headache. Arm hurts at injection site. Very tired. slept 14 hours and still tired. Temp has been around 99.5 when I've been awake enough to take it.
61 2021-02-06 malaise, fatigue, chills I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty ba... Read more
I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day
61 2021-02-07 runny nose, fatigue, chills, headache, cough, fever Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; ... Read more
Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient (non-pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included Irritable Bowel Syndrome with Constipation (IBSC), anxiety, allergies, Known allergies: sulfa. Historical vaccine included 1st dose of BNT162B2 (lot: EL1284) on 28Dec2020 at 14:00 via intramuscular at single dose on right arm for COVID-19 Immunization. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), lisdexamfetamine mesilate (VYVANSE) and linaclotide (LINZESS). The patient experienced body aches, fever (100.1), chills, runny nose, cough, headache, fatigue, neck pain and head congestion, all on 21Jan2021 at 14:45 with outcome of resolving.No treatment was received for the events. This case was reported as non-serious.
61 2021-02-07 chills, fatigue, headache Pt stated -Onset 12-16 hours post injection of shills, headache, body ache, joint pain and fatigue. ... Read more
Pt stated -Onset 12-16 hours post injection of shills, headache, body ache, joint pain and fatigue. The symptoms lasted a day and resolved.
61 2021-02-07 fatigue, headache She had significant fatigue the day after the injection along with a sore arm and intermittent heada... Read more
She had significant fatigue the day after the injection along with a sore arm and intermittent headache. Starting about 72 hours after the vaccine she noticed a swollen lymph node at the base of her neck on the side of the injection. The lymph node, sore arm and intermittent headache are still present.
61 2021-02-07 sleepiness, chills chills, body ache, sleepy
61 2021-02-08 body temperature increased, fatigue On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal ... Read more
On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal cramping and pain , Temp 99.3 On 2/8 stomach uncomfortable, fatigue and muscle aches. 2/9 feel tired
61 2021-02-09 headache Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneou... Read more
Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.
61 2021-02-09 influenza like illness, headache I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopp... Read more
I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopped at day 3. After the second dose, 3 weeks later, the symptoms appeared later but held on to day 5 or 6, except the more extreme dizziness which I still have. It is worse on some days and there is some nausea in the mornings with headache. I have never had vertigo but this is what I imagine it to be.
61 2021-02-09 headache splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mout... Read more
splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mouth for 3 days.; This is a spontaneous report from a contactable other hcp, the patient. This 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), dose number 1, via an unspecified route of administration in the right arm on 29Dec2020 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus from 1974 to an unknown date (T1DM dx 1974) and aortic valve replacement from 1990 and unknown if ongoing (AVR 1990 and 1992). Concomitant medication included insulin (INSULIN), simvastatin (SIMVASTATIN) and lisinopril (LISINOPRIL). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 31Dec2020, the patient experienced metallic taste in mouth for 3 days. On 07Jan2021 at 13:00, the patient experienced splitting headaches, chronic nausea began and vomiting which was explosive and unpredictable. No therapeutic measures were taken as a result of the events. The clinical outcomes of the metallic taste in mouth for 3 days, splitting headaches, vomiting and chronic nausea were not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
61 2021-02-16 fever, headache, fatigue Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101... Read more
Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have
61 2021-02-16 fever, headache, chills Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills, sev... Read more
Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills, severe body aches, severe headache lasting about 9 hours starting at midnight following the vaccination.
61 2021-02-17 influenza like illness This is a spontaneous report from a non-contactable consumer. A 61-year-old female patient (not preg... Read more
This is a spontaneous report from a non-contactable consumer. A 61-year-old female patient (not pregnant, age at vaccination reported as 61-years-old) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (left arm), on 02Feb2021, at single dose, for covid-19 immunization. Medical history included sulfa allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), for covid-19 immunization. The patient felt flu like symptoms the day after the second vaccination dose on 03Feb2021. Symptoms have resolved on the second day after vaccination. The patient recovered from the adverse event on 04Feb2021. No treatment was received for the adverse event. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
61 2021-02-21 chills, body temperature increased, fatigue 2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10... Read more
2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10:50am, Temp 100.3F at 5:15pm Temp 101.3F at 9:10pm and took tylenol and regular medications, Temp 100.6F at 10:55pm and went to sleep. 2/11/21: woke up with temp 98.7 at 10:00am, had body aches, red and feverish area where vaccine was given in upper left arm. The red, itchy and feverish area about 3 inches x 2 inches on upper left arm lasted about 5 days, also got a lump under left arm that lasted about 6 days and all of these went away by 2/17/21. But I've had more fatigue, and shortness of breath since this 2nd vaccine. Misses my doctor appointment on 2.17/21 due to the winter storm, not going anywhere , we were having all last week.
61 2021-02-21 headache patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of va... Read more
patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.
61 2021-02-22 chills, headache, throat pain Right side upper arm ache spread to right side of neck and into headache at back and top of skull. ... Read more
Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.
61 2021-02-22 chills, malaise, headache Severe dizziness, severe headaches, chills, muscle aches, malaise
61 2021-02-22 fatigue, headache, chills nausea, vomiting, headache, tired, chills, pain in injection site
61 2021-02-23 headache 1. Facial numbness 2. Nausea 3. Pain in back of neck 4. Headache
61 2021-02-23 cough, headache Covid 19 Vaccine screening questionnaire reviewed , administered Covid vaccine; patient developed co... Read more
Covid 19 Vaccine screening questionnaire reviewed , administered Covid vaccine; patient developed coughing spells, non productive after 2-3 minutes after the vaccine administration, she states she felt like fainting. Lung sound checked - no wheezing. Pulse Oximetry checked 96%. Observed for 30 mins in the field. Intermittent coughing still noted. Pulse oximetry remained 96%, no shortness of breath or difficulty breathing. After 3 0 mins, patient continue to cough , states she feels tickles in her throat that makes her cough and she has a headache. Patient given Benadryl 25 mg p.o. and monitored for 30 mins. Patient felt better after 25 mins of observation and minimal coughing , pulse oximetry @ 96-98% denies SOB or difficulty breathing . Patient sent home with husband and advised to rest at home and call 911 if she develops SOB or difficulty breathing. Followed up call over the phone at 5: 00 PM , patient states she fell asleep when she went home and no cough , no SOB or difficulty breathing.
61 2021-02-23 dehydration, fatigue Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is ... Read more
Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.
61 2021-02-23 headache Received first COVID vaccination at 3:50pm and 5-10 minutes later began to experience pain and throb... Read more
Received first COVID vaccination at 3:50pm and 5-10 minutes later began to experience pain and throbbing in jaw and lower molars. pain began moving forward. tongue began to tingle and mouth went numb. Glands were swollen and pain was experienced in both ears, under both eyes and cheek bones. Also experienced pain in the top and back of head.
61 2021-02-24 influenza like illness, fatigue Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My ... Read more
Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My lymph nodes right neck is swollen, also painful mass around 2x3cm below right clavicle near the sternum. I also have flu-like symptoms, body weakness especially lower extremities. Rashes and itchiness upper chest still present. 2/9/21 : Lymph node swelling of right neck & below right scapula still present. Rashes & itchiness upper chest still present but controlled with hydroxyzine tablet. Flu-like symptoms still present. 2/11/21: Rashes & itchiness minimal, less medication needed. Lymph node swelling less, still gets tired easily. 2/19/21: lymph node below right clavicle bigger for 1 day. No more lymph node swelling right neck. Still gets tired easily. 2/24/2021: Lymph node below right clavicle 1x1 in size, not painful.
61 2021-02-25 headache Headache, bodyaches, dizziness, oral temp 99.0F
61 2021-02-25 fever, throat pain, chills chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helpe... Read more
chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
61 2021-02-26 fatigue, fever, headache, chills Extreme chills, fever, body aches, headace, extreme fitigue, swelling and pain at injection site
61 2021-02-26 headache, body temperature increased, fatigue Headache, slight elevated temperature, tired
61 2021-02-27 chills Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and n... Read more
Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and nausea stopped by the next morning. But the ringing in my head/ears is still going on. It?s driving me crazy. It?s a high pitch buzzing sound that never stops. At times I feel dizzy and nauseous because of it.
61 2021-02-27 runny nose, head discomfort, headache Pain at the injection site was typical for vaccination and was essentially gone by the next day. Hea... Read more
Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.
61 2021-02-27 headache, nasopharyngitis, fatigue cold symptoms, headache, sore arm, fatigue
61 2021-02-28 fever Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if... Read more
Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.
61 2021-02-28 headache Nothing too horrible... Nasseau periods, and diarrhea for 2 days, slight headache. I took some pept... Read more
Nothing too horrible... Nasseau periods, and diarrhea for 2 days, slight headache. I took some pepto bismol today. Hope it helps. I am still not sure if these are due to the vaccine or not?
61 2021-02-28 sleepiness Rash, itchy around neck, hot, weak, drowsy, evaluated by EMS-transported to nearest ER
61 2021-02-28 headache, fever, chills arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips ... Read more
arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.
61 2021-03-01 fatigue, fever, chills, headache Chills and headache beginning 10 pm of the day of injection, followed by fever, nausea, body aches, ... Read more
Chills and headache beginning 10 pm of the day of injection, followed by fever, nausea, body aches, sinus congestion soon thereafter and extreme fatigue. Aleve (2 tablets) at 7 am the next morning with little, if any, relief but perhaps prevented it from becoming worse and another at 2:30 am on Monday morning (the second day). Slept, although not always well, for the better part of 32 hours, with less than 3 hours of being awake and up, trying to eat little. Was able to make it through a nine hour shift on Monday, still with no appetite and a bit off (attributed to not being truly rested despite 32 hours in bed).
61 2021-03-02 chills, fever Fever 102.1; Chills; achy; This is a spontaneous report from two contactable healthcare professional... Read more
Fever 102.1; Chills; achy; This is a spontaneous report from two contactable healthcare professionals. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) at the age of 61 years, intramuscular on the left arm on 27Jan2021 16:15 at a single dose for COVID-19 immunization. Medical history included high blood pressure, COVID-19 and allergies to quinolones. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously took celecoxib (CELEBREX) and experienced allergies. The patient experienced fever 102.1, chills and achy on 28Jan2021 08:00. The patient did not received any treatment for the events. The outcome of the events was not recovered.
61 2021-03-02 headache Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right si... Read more
Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right sided chest pressure with shortness of breath. Used her inhaler, which helped with shortness of breath. EMS was called and patient was transported to the ED where she also endorsed a headache. EKG showed some ST depression with T-wave inversion that was not present in 2008. Patient was monitored for a few hours - had 2 negative troponins and repeat EKG and was discharged home.
61 2021-03-02 fever, chills, headache pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the... Read more
pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the pain and her reaction lasted around 24 hours . The symptoms had subsided by 2 PM the next day.
61 2021-03-03 chills Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chil... Read more
Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chills, throat discomfort. Patient had improvement with water, O2 and juice. Patient left in wheelchair after 90 minutes of observation with resolution of tachycardia and throat discomfort.. States she had similar reactions to influenza vaccine in past, but did not last that long. We discussed ER evaluation at which patient elected to go home as she had driver and wanted to go home. Patient instructed Benadryl, rest and fluids day of event. 911/ER if worsening symptoms. Patient in agreement to plan.
61 2021-03-04 fever, headache Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly reso... Read more
Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later
61 2021-03-04 cough, headache still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 wen... Read more
still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-03-07 fever, fatigue, chills Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse... Read more
Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and Hashimoto's disease; the patient was allergic to sulfa and penicillin. Concomitant medications included enalapril, sertraline, lansoprazole (PREVACID) and rosuvastatin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) on 05Jan2021 at 12:15 in the left arm. On 26Jan2021 at 15:00, the patient experienced exhausted, chills, aches, fever 100.8 and nausea. All the events were considered as non-serious. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and she went to bed-slept for 14 hours straight. The patient recovered from the events on an unspecified date. The patient had not COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination.
61 2021-03-07 headache, fever arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days;... Read more
arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.
61 2021-03-09 headache Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consume... Read more
Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (reporter and reporter's husband). This is the first of two reports. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269 and expiry date: unknown),via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included diabetic and high blood pressure. Concomitant medication included metformin and, hydrochlorothiazide, losartan potassium (HYZAAR). Patient got the vaccine on 04Feb2021, last Thursday and the effects have not been bad, it was just arm sore on the same day. She did not have any headache but yesterday on 06Feb20021, she had a headache. No treatment was received for the events. The second dose was scheduled on 25Feb2021. Outcome of the events was recovered on Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021174383 same reporter, vaccine, different patient and event
61 2021-03-15 lethargy, pneumonia Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weak... Read more
Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.
61 2021-03-15 fatigue She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormal... Read more
She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormality; she has heart rhythm problem (premature atrial contraction); feeling exhausted; This is a spontaneous report from a contactable Nurse (patient). A 61 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249), via an unspecified route of administration on 19Jan2021 (at the age of 61 -years-old), single dose for COVID-19 immunization. Medical history included covid infection over a year ago. The patient had no concomitant medicines were not reported. The patient She had flare ups when she took Hep b vaccine before and did not get the 2 remaining doses because of the reaction. She has had so many vaccines over the years and had her flu shot every year. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 19Jan2021. Consulted the doctor 01Feb and told she has heart rhythm problem (premature atrial contraction). She also experienced shortness of breath. Not sure if it is vaccine related or due to her age. She will have the 2nd dose on 09Feb2021. Stated that she was feeling exhausted (29Jan2021) and out of breath. Stated that the doctor told her that her heart rhythm out of sync. Stated that in Dec she had her heart checked and it was okay. Stated that her other Covid is due to be given 09Feb. Does not know if the vaccine is contributing to her heart rate's bivalvular rhythm. Stated that she had Covid infection over a year ago. Stated that she is worried that the vaccine caused an abnormal rhythm to her heart. Stated that she has a new heart rhythm abnormality. Stated that she had all of her lab work done on 11Jan2021 and it was okay. Stated that on 27Jan-28Jan that she tried to pick up a watermelon and was short of breath for no reason. Stated that it happened a couple of times. Stated with her rhythm being out of sync that it feels like her heart is failing. The outcome of the event dyspnea was recovered, heart disorder and fatigue was not recovered, other events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported arrhythmia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
61 2021-03-15 fatigue, headache Swelling/pain in Left deltoid at injection site; Mild frontal headache; Fatigue 4 hours after vaccin... Read more
Swelling/pain in Left deltoid at injection site; Mild frontal headache; Fatigue 4 hours after vaccine Mild frontal headache; Swelling/pain in Left deltoid at injection site; This is a spontaneous report from a contactable nurse (patient). A 61-year-old non-pregnant female patient received BNT162B2 (solution for injection; lot number: EL9264) in left arm, via an unspecified route of administration on 09Feb2021 09:30 am at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included osteopenia, mild depression. The patient had no known drug allergies. The patient concomitant medications included citalopram, ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+). The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient experienced Swelling/ pain Left deltoid at injection site, fatigue 4 hours after vaccine, mild frontal headache on 09Feb2021 13:00. The patient did not receive treatment for the events. Outcome of vaccination site swelling and pain was recovered on an unspecified date of 2021 and rest of the events was unknown.
61 2021-03-15 chills nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; ... Read more
nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
61 2021-03-23 headache BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; ... Read more
BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.
61 2021-03-24 headache, fatigue, sweating Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh... Read more
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
61 2021-03-24 fatigue minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); ext... Read more
minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); extensive cholestasis; symptoms of mild decrease appetite; some fatigue; This is a spontaneous report from a contactable Physician. A 61-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hemiparesis, hypertension, hyperlipidemia, recurrent UTI. Concomitant medications included AMLODIPINE BESILATE, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for UTI, cefalexin KEFLEX [CEFALEXIN] and nitrofurantoin for UTI. The patient received first dose of BNT162B2 on 29Dec2020. On 02Feb2021 the patient experienced minimal chronic portal inflammation, symptoms of mild decrease appetite, some fatigue and extensive cholestasis. Serologic workup was notable only for ASMA 1:160, including extensive viral and immune workup Liver performed on 24Feb2021: extensive cholestasis, normal reticulin and trichrome stains, minimal chronic portal inflammation; no lobular or interface activity. The patient underwent Sars Cov2 test on 22Feb2021 which resulted negative. At the time of the reporting the patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Hepatitis, cholestasis and other events due to temporal relationship . Additional information is needed to better assess the case, including complete medical history, diagnostics including liver function tests/hepatic enzymes prior to subject drug therapy and during subject drug therapy, abdominal ultrasound, CT/MRI of abdomen, viral hepatitis serology, serum bilirubin, serum alkaline phosphatase, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-03-30 throat irritation, productive cough, malaise, headache Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and ... Read more
Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
61 2021-03-30 throat irritation Patient was given vaccine at 10:45am - Patient reported scratchy throat at 10:48am - at 10:50am we g... Read more
Patient was given vaccine at 10:45am - Patient reported scratchy throat at 10:48am - at 10:50am we gave 50mg of Diphenhydramine orally, patient condition worsened, she described her throat starting to swell up, and had noticeable difficulty breathing and shortness of breath. We administered Epinephrine at 10:55am and within 5 seconds patient reported improvement. Patient remained stable until EMS arrived about 5-10 minutes later. Patient was advised to be taken to the hospital for monitoring and agreed. She remained stable and reported an "itchy back" upon exit.
61 2021-03-31 malaise felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quen... Read more
felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
61 2021-03-31 lethargy, headache received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and v... Read more
received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and vomiting. EMS reports that she was found sitting in her van lethargic and actively vomiting. When EMS arrived they noticed that the patient had her fingers in her throat trying to induce vomiting. EMS reports EKG in sinus rhythm with HR 84, BP 178/106, and O2 sat 99% on RA. EMS did not notice focal weakness. Pt c/o HA and is noted on arrival to not be moving her LUE. I spoke with her daughter, who said she spoke to the pt on the phone at 10:45 am today and that she seemed normal at that time. She reports the pt does not have h/o cancer or heart disease and is unaware of any pt medication allergies. She reportedly received her COVID vaccine yesterday.
61 2021-04-06 fever Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs ac... Read more
Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; temp of 101.6; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 01Mar2021 17:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included end stage renal disease (ESRD), high blood pressure and pulmonary hypertension; all from an unknown date and unknown if ongoing. The patient has no COVID prior vaccination and not tested to COVID post vaccination. There was no other vaccine in four weeks. Concomitant medications (reported as Other medications in two weeks) included clonidine (CLONIDINE), macitentan (OPSUMIT), minoxidil (MINOXIDIL), carvedilol (CARVEDILOL), and tadalafil (ADCIRCA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (lot number: unknown) first dose on 22Jan2021 at 02:45 PM right arm for covid-19 immunization. The patient also previously took Hydralazine and experienced allergies. It was reported that on 01Mar2021 08:00 PM the patient went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs., acting stiff and unusual behavior. The patient's daughter took the patient and had a temp of 101.6 was sent home Tuesday morning. The events resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with sequalae (reported as with lasting effects). No treatment was given for the events. Information on the lot/batch number has been requested.
61 2021-04-07 sleepiness, fatigue The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The... Read more
The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The next day woke up disoriented and weak. Called dr and dr recommended her call the ambulence. Went to ER and admitted to hospital. They said she had an infection and got on antibiotics. In the hospital 2-3 days and dismissed. Continue to have weakness and severe fatigue. Had 3 "MS hug"- muscles severely contract during this time- has to take muscle relaxer.
61 2021-04-08 cough racing heartbeat, breathlessness, coughing, nausea
61 2021-04-10 headache I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood press... Read more
I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before. I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
61 2021-04-11 throat irritation Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard... Read more
Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.
61 2021-04-13 cough, chills, fatigue Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills... Read more
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
61 2021-04-16 fatigue, throat pain, cough test positive for COVID 19; test positive for COVID 19; coughing; Muscle aches; Fatigue; Sore throat... Read more
test positive for COVID 19; test positive for COVID 19; coughing; Muscle aches; Fatigue; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 16Jan2021 10:30 as single dose for covid-19 immunisation. Medical history included high blood pressure, migraines, inflammatory arthritis, penicillin allergy. Concomitant medications included eszopiclone (LUNESTA) (MANUFACTURER UNKNOWN); valsartan (MANUFACTURER UNKNOWN); sumatriptan succinate (IMITREX) (MANUFACTURER UNKNOWN). On 8Feb2021, the patient experienced coughing, muscle aches, fatigue, sore throat. On 23Feb2021, the patient experienced test positive for covid 19. There was no direct adverse reaction from the vaccine, but I did test positive for COVID 19 on 23Feb2021 (yesterday) with symptoms of coughing, muscle aches, fatigue and sore throat. The patient underwent lab tests which included sars-cov-2 test: negative on 19Feb2021 and sars-cov-2 test: positive on 23Feb2021. The patient did not receive any treatment for the events. The clinical outcomes of the coughing, muscle aches, fatigue, sore throat, test positive for covid 19. No follow-up attempts are possible.
61 2021-04-17 fatigue Extreme weakness & Fatique Dizziness Fainting Death 04/09/2021
61 2021-04-17 chills My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super water... Read more
My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
61 2021-04-17 fever, productive cough, sneezing, chills, nasopharyngitis This is a spontaneous report from received from contactable consumer. A 61-year-old female patient r... Read more
This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in. On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club. Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.
61 2021-04-17 fever, cough, headache dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache;... Read more
dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
61 2021-04-18 fatigue having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, lef... Read more
having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
61 2021-04-18 headache, malaise tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light a... Read more
tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
61 2021-04-21 headache After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the ... Read more
After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.
61 2021-04-24 headache Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient... Read more
Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:00 (at the age of 61years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 06Mar2021 12:00 (at the age of 61years) for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Bell's Palsy 10 days later. It was further reported that the patient had a persistent headache from date of second vaccine to now (pending clarification), including onset of Bell's Palsy. The onset date of adverse events was 07Apr2021 (11:00 AM) (as reported). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with steroids and anti-viral. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information on the lot/batch number has been requested.
61 2021-04-24 headache Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headach... Read more
Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; It is extremely irritating; Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; This is a spontaneous report from a contactable consumer (patient). This 61- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 01Mar2021 at 12:00 AM (at the age of 61-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was reported as "other" and anatomically located on the left arm. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EL9265,) dose 1 on 08Feb2021, for covid-19 immunization. No allergies to medications, food, or other products. The medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, she experienced Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing thou is still present 24/7. It is extremely irritating and there is nothing i can do to make it better. Treatment was not received for the adverse event. The clinical outcome of the events was not recovered. On 05Apr2021, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result. No follow-up attempts are possible. No further information is expected.
61 2021-04-24 fatigue, headache Mild headache and moderate fatigue exacerbated with activity; Mild headache and moderate fatigue exa... Read more
Mild headache and moderate fatigue exacerbated with activity; Mild headache and moderate fatigue exacerbated with activity; This is a spontaneous report received from a contactable nurse (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via unspecified route of administration in left arm on 12Feb2021, (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient was non-pregnant at the time of vaccination. The patient medical history included stage 1 hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19, undergone Nasal Swab on 21Feb2021 and resulted in negative. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient concomitant medication included multivitamin. The patient previously took Keflex and experienced allergy. On 13Feb2021, the patient experienced mild headache and moderate fatigue exacerbated with activity. The patient visited physician office for the events. The patient did not receive treatment for the events. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) in left arm on 09Mar2021 for COVID-19 immunisation. The seriousness of the events was reported as disability. The outcome of the events was not resolved. Information on Lot/Batch number was available. Additional information has been requested.
61 2021-04-24 headache felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Heada... Read more
felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
61 2021-04-27 fatigue, throat pain, body temperature increased I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pai... Read more
I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
62 2020-12-31 sweating REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77... Read more
REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77. 25MG BENADRYL GIVEN.
62 2021-01-01 headache Headache
62 2021-01-01 fatigue Severe left upper extremity pain and fatigue for two days after that I took two Tylenol?s and all t... Read more
Severe left upper extremity pain and fatigue for two days after that I took two Tylenol?s and all the symptoms subsided
62 2021-01-02 cough, throat pain, influenza like illness, chills 9 DAYS POST VACCINATION EXPERIENCED SORE THROAT, MILD DRY COUGH, CHILLS W/O FEVER, GENERALIZED FLU L... Read more
9 DAYS POST VACCINATION EXPERIENCED SORE THROAT, MILD DRY COUGH, CHILLS W/O FEVER, GENERALIZED FLU LIKE MUSCLE ACHES.
62 2021-01-02 fever, headache, fatigue, malaise Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours l... Read more
Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite
62 2021-01-03 fatigue, nasal congestion, headache Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe ... Read more
Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.
62 2021-01-04 influenza like illness 6 to 7 minutes after vaccine felt flu like symptoms then could taste medicine. Breathing seemed to ... Read more
6 to 7 minutes after vaccine felt flu like symptoms then could taste medicine. Breathing seemed to slow down, blood pressure went to 140/90 and always have low blood pressure then tongue felt numb. I work at a hospital so they took me to the ER
62 2021-01-04 headache By 1400 had low grade HA, by 1600 more severe. Managed with Tylenol. 1800 no appetite, and nauseat... Read more
By 1400 had low grade HA, by 1600 more severe. Managed with Tylenol. 1800 no appetite, and nauseated. Continued through night.
62 2021-01-04 chills, fever, headache Chills, headache, fever, achey
62 2021-01-04 throat irritation Five minutes after vaccine patient had itchiness around eyes, itchy throat and mild shortness of bre... Read more
Five minutes after vaccine patient had itchiness around eyes, itchy throat and mild shortness of breath. Later, patient reported swelling around eyes and lips.
62 2021-01-04 headache Had gotten a headache within 1/2 hour of getting the injection. Within 2 hours after receiving the i... Read more
Had gotten a headache within 1/2 hour of getting the injection. Within 2 hours after receiving the injection my arms started to itch and upper back areas. Within 4 hours I noticed rash like redness with tiny little spots/bumps all up and down both arms and the itching was getting worse with both arms and upper back areas. This went away by Friday evening. I had the headache until the following Monday evening.
62 2021-01-04 headache Headache, dizziness, earache
62 2021-01-04 fever, fatigue, chills, headache Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue.... Read more
Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue. Slept most of the day. Took acetaminophen when able to drink. Drank ginger tea and ate dry toast in the evening. Tuesday, HA controlled with Acetaminophen and Ibuprofen. Able to eat and increase fluids. Consulted with my PCP who suggested I enter my information. Feeling stronger as time passes. I believe another nights sleep will help.
62 2021-01-04 fatigue, headache Severe headache from 12/30 0400 to 1/3/21, extreme fatigue, and excessive thirst
62 2021-01-04 fever, chills, fatigue, headache, malaise fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore ... Read more
fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore arm /arm soreness; tired; felt like she had a flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included Diabetes, allergies, heart (Heart disorder). Concomitant medications included irbesartan (AVAPRO) for heart, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies, metoprolol for heart, metformin for Diabetes, all were ongoing. The patient (Hospital scheduler/employee) had been experiencing side effects of the vaccine. She took the vaccine on 18Dec2020 and still experiencing nausea, headaches, and chills. She asked how long she would experience these side effects and if she needed to take anything. Patient reported she was exposed to someone who had COVID, her son's girlfriend had direct exposure to COVID and wanted to know how it would affect her. The patient further stated she was a hospital scheduler, she had the Pfizer Covid vaccine on 18Dec2020. She had a sore arm/arm soreness and was tired immediately after (18Dec2020), stated by Saturday 19Dec2020, she started having a low-grade fever, chills, headache, nausea, and still had the soreness in the arm. This went on for 2-3 days. Patient stated that up until now, she still had nauseous feeling that happened intermittently around early morning or mid-day, the chills were midday to early evening, it was like she didn't feel good, had to leave early from work. The fever only lasted a couple of days. She also had one isolated episode of fast heart rate that woke her up in the early hours of Sunday 20Dec2020. Caller stated she expected some of these effects to only last a couple of days but wanted to know if this was normal. She tried working 2 days last week and by mid-day she was just really tired, like she was about to get the flu, she felt like she had a flu just with no respiratory symptoms (De2020). She knew of one other coworker who was experiencing similar symptoms. No patient identifiers were provided, no further information provided. Patient did have history of allergies from when she was a child and was on medication, she was on over the counter medication Zyrtec for years, she didn't know if there could be a conflict between them. She received her vaccine part of the hospital. She also called because her son and his girlfriend live in her house and his girlfriend was exposed to someone who tested positive for Covid, she wanted to know how this may affect her since she had the vaccine. Investigation assessment was no. The outcome of the event "sore arm /arm soreness" was recovered in Dec2020, of "low grade fever" was recovered on 21Dec2020, of the events "tired", "nausea", "headache" and "chills" was not recovered, of the other events was unknown. Information about Lot/Batch number has been requested.
62 2021-01-04 chills, fatigue fatigue chills arm soreness
62 2021-01-05 fatigue, chills, fever 1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white no... Read more
1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED
62 2021-01-05 sleepiness, headache, chills, fatigue, malaise Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asle... Read more
Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asleep most of the whole day; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Arp2021), via an unspecified route of administration on 30Dec2020 at single dose at right arm for Covid virus. Medical history included blood thinner treatment. Concomitant medication included ongoing apixaban (ELIQUIS) for blood thinner treatment. The patient previously took coumadin, warfarin. Patient received the Covid-19 vaccine yesterday. She had been asleep most of the whole day (Dec2020). She had injection site pain, headache, tiredness, muscle pain and chills. She thought she was going to work but that didn't work. She was currently taking Eliquis. She had been on coumadin and warfarin before. She looked at the different medications that needed to be reported. She would also call her physician and make her aware. The start date for "Injection site pain" was 30Dec2020. The start dates for headache, tiredness, muscle pain and chills all were 31Dec2020. The patient also experienced nausea, feeling unwell on 31Dec2020. Investigation assessment was no. The outcome of the event "Injection site pain" was not recovered. The outcome of the other events was unknown.
62 2021-01-05 chills, fever, throat pain, headache Fever,body aches,chills,heada he body aches,light sensitivity,,sore throatpain at site
62 2021-01-05 headache Headache for 7 days then resolved
62 2021-01-05 chills, fatigue, malaise, fever I got my shot on the 19th and that evening it was like a light switch and I was so tired I went to s... Read more
I got my shot on the 19th and that evening it was like a light switch and I was so tired I went to sleep at 730pm I had severe chills and fever and had to go to bed. The next day I still wasn't feeling well and I was called in to get covid tested and I went to the ER on the 21st and took a rapid covid test that was positive. I was stable and had good oxygenation and was discharged. I have fever nausea vomiting I also had problems with O2 stat i was in the 80s and realized I was having respiratory failure so I was admitted on the 27th and I've been here ever since. I had kinetic storm and infusions my O2 stats were bad and I was sent to the covid unit and put on high flow oxygen and negative for a PE, I'm still on the covid unit but I feel much better today
62 2021-01-06 cough CoughWheeze
62 2021-01-06 headache, fever Patient report HA and fever. Treatment include Tylenol .
62 2021-01-06 chills, fever chills, fever, joint pain, muscle aches
62 2021-01-07 malaise, headache, sleepiness 10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on r... Read more
10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on road, my tongue started to tingle and then my lips started to tingle and both sides of face felt numb. This started around 10:50pm? Went to bed and woke up Sat with same tongue, lip tingleling and face numbness. Lips felt very swollen. Felt that way throughout the weekend. On Monday, went back to work place injection area and requested someone talk to me. Nurse practioner came out and spoke to me, asked about balance of facial features, no problem breathing or swallowing and gave me 25mg benadryl to take 3 times a day. Did nothing but make me sleepy. She calls me Tue am and told me to make an appt with PCP. Made phone appt for Wed. Dr calls me Wed am and gives me presciption for 60mg Prednisone to take for a week (at this time symptoms are the same). the first 3 days taking Prednisone the intensity of tingleling seems to lessen day by day. But on 4th day, the symptoms stopped lessening. Finished the meds anyway. Last 3 days, i've also had that mild headache back in addition to the numbness from face traveling up to my ears. Past few days the tingling in tongue isn't confined to just the edges of the tongue. It started with the first 1/4 of whole tongue and is today tingleling in the front half of whole tongue. One good thing so far is the past few days, my lips feel way less swollen and tingleling is lessening. So, riding this out, hoping it will end sometime this year. Will not be getting the second shot. Just so you know.
62 2021-01-07 headache 46 hours after receiving vaccine, experiencing twinges of moderate to severe headache and/or ear pai... Read more
46 hours after receiving vaccine, experiencing twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020; 46 hours after receiving vaccine, experiencing twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection in the left arm on 30Dec2020 at 13:15 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included COVID-19 in Mar2020. Concomitant medications included atorvastatin, colecalciferol (VITAMIN D) and cetirizine. The patient no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 in Mar2020. On 01Jan2021 at 10:30 (about 46 hours after receiving vaccine), the patient experienced twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020. No treatment was provided for the events ear pain and headache. The outcome of the events ear pain and headache was unknown. Since the vaccination, the patient has not been tested for COVID-19.
62 2021-01-07 chills, headache, fatigue At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe bod... Read more
At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe body aches for an hour. 18 hrs after injection was mild-moderate headache and moderate tiredness and confusion for another 4-6 hrs.
62 2021-01-07 fatigue, headache Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day... Read more
Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint); slight nausea/nausea; slight fatigue; slight headache; slightly stiff neck; right arm pain; The muscles knot up under her rib cage/muscle tightness; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscularly in the left arm on 29Dec2020 at 06:30 at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VIT D), levothyroxine (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy from an unspecified date to an unspecified date, influenza vaccine (FLU VACCINE) for an immunization on an unspecified date (received within two weeks of vaccination). The patient experienced the following events and outcomes: muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint) (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight nausea/nausea (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight fatigue (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight headache (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slightly stiff neck (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, right arm pain (non-serious) on 30Dec2020 with outcome of unknown, back pain (non-serious) on 31Dec2020 with outcome of unknown, the muscles knot up under her rib cage/muscle tightness (non-serious) in Dec2020 with outcome of unknown. The patient received the COVID-19 vaccine on 29Dec2020 at work, and she had been experiencing adverse events since. The worst side effect she was experiencing was muscle tightness. At the time of the report, the patient got up at 09:00, and her "back was killing her." The patient was achy. The patient would tighten up really tight under both rib cages, and it made her nauseous. The patient had been taking ibuprofen (ADVIL) and ibuprofen (MANUFACTURER UNKNOWN since she received the vaccination. The patient received the vaccine in her left arm, but her right arm hurt the next day. The next day after that (30Dec2020) she woke up and the right side of her back around the kidney area hurt. It was the right side lumbar. The next morning after that, "her entire back was killing her down the middle of her spine. From her head all the way down." Since then, it came and went. The patient could not say if it was persisting, improving or worsening for any of the symptoms. "It just grabs her." The day before the report, the patient thought she was doing better. The patient cleaned the house, and then sat down to eat. The past two nights, it had "hit her really hard during supper time." Both of her sides of her back would tighten up; "tense up like waiting for an impact before a wreck." The patient's back would seize up. The patient could not get comfortable; and would start pacing. Then, she would try to lay down. Last night, it took a half an hour to loosen back up. "It knots up like crazy. It was bad enough, she thought she was going to pass out." The patient did not know if it was the combination of eating supper or what. The patient thought if she got up that maybe she would feel better. The patient started pacing around. The patient went outside because she thought maybe fresh air would help. When it would tighten up under her rib cage, it made her nauseous. The patient did not know if it was a "vagus nerve thing or what." The patient was close to throwing up. The muscles knot up under her rib cage. The patient's back felt like she fell off a horse. It was weird to her that her left arm never bothered her. "Nothing stays the same." Sometimes it was her entire arm or part of the arm that hurt. Like on top of her forearm. The patient thought she was doing good and then it would come back. When she moved her arm upward, she felt it. The patient said she could deal with the arm pain. It was the knotting up pains that were the worst. The patient tried calling an institute (name withheld) because it happened while eating dinner the other night. The institute (name withheld) "nurse was useless." The pain was across her sacroiliac area. The patient had been "living on Advil and ibuprofen for her back pain." The patient had been taking them together. The patient worked nights, and she was planning on going to work the night before the report, but she had to text her boss and tell her she could not come in. The patient was in good health; had perfect blood pressure and her sugar was normal. The patient was not diabetic. The patient's labs were always normal. The patient was really dreading that second shot. "The flu shot kicked her butt for a couple of days, but this was way worse." The patient started reading up on the COVID vaccine, and it said usually younger people had severe side effects. That old people have less of a response. The patient did not know why she was experiencing such side effects. At the time of the report, it was day 7 or 8, and she was still feeling bad. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
62 2021-01-07 headache, fatigue, chills Chills, headache, muscle pain, tiredness, and nausea.
62 2021-01-07 fever, headache, chills Fever 100.6 F , chill, headache, pain
62 2021-01-07 malaise, headache, fatigue Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upp... Read more
Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upper back,upper chest and bend of both arms.Benadryl 25 mg OTC 1/6/21 and 1/7/21.Itching. Itching decreasing 1/8/21. Having copious side effects also of injection site pain,tiredness,headache,joint and muscle pain,nausea,lymphadenopathy and feeling unwell.1/6/21,1/7/21 but feeing better when tylenol 500mg ing system to relieve aches and pains
62 2021-01-07 chills, headache Headache, Myalgia chills
62 2021-01-07 fever, headache Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She ha... Read more
Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She has not had history of reaction before. Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing. She has a history of afib and last night she had two runs of it and took metoprolol.
62 2021-01-07 headache, fatigue Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and h... Read more
Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and headaches which seemed to move around my body for about 24 hrs. At one point it seemed to settle into my hand. Knuckles swelled arthritis like. When walking up stairs I had significant muscle weakness in my legs and exertional dyspnea. Eyes felt "feverish" but had no fever. The next morning while trying to do a routine workout the same thing happened. It was a significant change to my normal condition. The dyspnea was the most concerning. The body aches settled into my lower back. Fatigue was moderate-moderately severe. As the day went on things waxed and waned. By the end of 72 hrs. most symptoms subsided. Friday 01/08/2021 I had a completely normal workout, no exertional dyspnea, fatigue subsided, no body aches. Back to normal. I would consider the symptoms to have been Moderate+.
62 2021-01-07 cough, throat pain Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore th... Read more
Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
62 2021-01-07 fatigue, fever body aches, low grad temp, nausea that led to one episode of dry heave vomiting, weakness & fatigue
62 2021-01-07 fever, chills chills, fever, muscle ache, joint pain
62 2021-01-08 chills, headache Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially.... Read more
Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially. Over 3 day period developed varying degrees of chills, headache, muscle aches. Fatigue on first day.
62 2021-01-08 headache, chills, fever Fever, chills, muscle aches, headache
62 2021-01-08 fever, fatigue, chills High fever, fatigued, chills
62 2021-01-08 chills Myalgia, NauseaVomiting, chills
62 2021-01-09 chills About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the... Read more
About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.
62 2021-01-09 throat pain, chills, fatigue, headache Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading i... Read more
Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading into work. Then @ 1030 feeling tired, neck & shoulder pain, chills, headache, right ear pain, slight sore throat, PO Motrin, 400mg moderate relief. Total of 30 hrs of recurring symptoms, alternating Tylenol & Motrin throughout. Started to feel better Saturday afternoon 4-4:30p
62 2021-01-09 chills, fever Fever 100.4 at 0100 am Chills, Body aches Took Motrin two hours later still chills and body aches To... Read more
Fever 100.4 at 0100 am Chills, Body aches Took Motrin two hours later still chills and body aches Took Tylenol. Two hours later , fever gone and chills stopped, body aches a little. Not much!!
62 2021-01-09 chills, fever Fever, chills, nausea, vomiting, dizziness, generalized ache for 24 hours. Tylenol, Zoran, Pepcid
62 2021-01-10 headache Arm pain @ injection site, able to sleep on right side; relieved with Ibuprofen. Headache, mild, nex... Read more
Arm pain @ injection site, able to sleep on right side; relieved with Ibuprofen. Headache, mild, next afternoon, relieved with Ibuprofen.
62 2021-01-10 headache Body aches and headache the morning following vaccination. Headache continued next day, but lesser. ... Read more
Body aches and headache the morning following vaccination. Headache continued next day, but lesser. Relieved by Ibuprofen both days.
62 2021-01-10 chills, fatigue, fever Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The ... Read more
Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The pain was terrible as was the fatigue and fever . I used Ibuprofen. 48 hours later I felt almost completely normal- no pain etc . Then 56 hours later resumption of chills fever for 4 hours . At 64 hours and after ibuprofen feeling better
62 2021-01-10 fatigue, headache, sweating, chills Excessive sweating, body aches intense,chills,fatigue,headaches stating after falling asleep and inc... Read more
Excessive sweating, body aches intense,chills,fatigue,headaches stating after falling asleep and increase all night and throughout the day.
62 2021-01-10 headache, fever Headache Fever, resolved after 24 hrs
62 2021-01-10 headache ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATI... Read more
ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATIONS. LASTED 48-72 HOURS. ALSO HAD HEADACHE, WHICH WAS PRESUMED TO BE SINUS HEADACHE, BUT DID NOT RESPOND TO SINUS MEDICATION. HEADACHE CONTINUED THRU 1/1/21 WITH NAUSEA ALSO NOTED. SYMPTOMS SUBSIDED BY 1/2/21
62 2021-01-10 headache On 1/6/21, I received the initial COVID vaccination. Later that evening, I started to experience pai... Read more
On 1/6/21, I received the initial COVID vaccination. Later that evening, I started to experience pain, swelling and redness at the injection site (right arm). I also had a severe headache with nausea. I was directed to get a COVID test, at the hospital on 1/7/21. I continued to experience these side effects of the vaccine for the next 2 days.
62 2021-01-10 runny nose Red rash and itching in 4 inch circumference around injection site that lasted 4 days. Sudden onset... Read more
Red rash and itching in 4 inch circumference around injection site that lasted 4 days. Sudden onset of runny nose and itching of eyes.
62 2021-01-10 chills Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tinglin... Read more
Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tingling in r hand, dizziness and chills throughout the day They would come and go. Late afternoon, Biceps went into spasms all fingers aching. After nap at 06:00 woke up and all symptoms gone. On 01/10/2021, woke up with tingling and burning from bilateral knees to toes. Lasted 2 hours and then gone. In afternoon 1 episode of dizziness and hot flashes followed by chills. 01/11/2021 Slight headaches. No bodyaches or other symptoms.
62 2021-01-10 chills, headache chill, headache
62 2021-01-10 fever, cough, chills shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever... Read more
shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
62 2021-01-11 headache 2nd dose- Headache, bodyaches pain at injection site and bruising; symptoms lasted for 24hrs then re... Read more
2nd dose- Headache, bodyaches pain at injection site and bruising; symptoms lasted for 24hrs then resolved. Pain and tenderness persist at injection site. 1st dose - no reported adverse events
62 2021-01-11 cough, headache A chest x-ray showed some inflammation on the lungs; Slight pain in her arms after taking the vaccin... Read more
A chest x-ray showed some inflammation on the lungs; Slight pain in her arms after taking the vaccine; Bad headache; She started to develop a cough after the injection that did not improve and had worsened by the end of the second week; This is a spontaneous report from a contactable Nurse (reporting for herself). A 62-year-old female patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on 18Dec2020 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. As reported, patient asked, "should I get the second injection of the COVID-19 vaccine since I have this cough that will not go away?." This female nurse, who was also the patient, reported receiving her first injection of the PFIZER COVID-19 VACCINE on 18Dec2020. She started to develop a cough after the injection that did not improve and had worsened by the end of the second week. Treatment has included cetirizine (ZYRTEC), dextromethorphan (ROBITUSSIN),Guaifenesin (MUCINEX) and albuterol inhaler. A chest x-ray showed some inflammation on the lungs and she was given a steroid inhaler, which has helped. She has received two COVID-19 tests at different time intervals, and both were negative. She was scheduled to receive the second COVID-19 vaccination on Friday but was uncertain if she should receive it given her cough was not improving. She had a bad cough, and other symptoms just before her injection (pending clarification). But her general practitioner (GP) put her in a steroid inhaler. She talked to her GP but can't give her complete advice as to whether she can still take the 2nd dose or not due to her situation. She said she had very slight pain in her arms after taking the vaccine, and felt a really bad headache on 18Dec2020. She would like to know if she still needs to continue the 2nd dose of vaccine or not since she still has a cough. Patient asked if there was any guidance on getting a second dose and what if test was a false positive and she really did have COVID-19?. Outcome of the event "She started to develop a cough after the injection that did not improve and had worsened by the end of the second week" was not recovered while "A chest x-ray showed some inflammation on the lungs", Slight pain in her arms and Bad headache were unknown. Information on the Batch/Lot number has been requested.
62 2021-01-11 nasopharyngitis, headache, chills About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then ach... Read more
About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then aches, uncomfortable to touch skin. Took 2 acetaminophen, lots of blankets, able to sleep. No fever, woke up with same symptoms but milder.
62 2021-01-11 malaise Atrial fibrillation; Was not feeling well; Warm sensation in chest; This is a spontaneous report fro... Read more
Atrial fibrillation; Was not feeling well; Warm sensation in chest; This is a spontaneous report from a contactable nurse (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EJ 1685), intramuscular, on 21Dec2020 at 09:30 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 62-years-old. The patient received also varicella zoster vaccine RGE (CHO) (SHINGRIX) on 19Nov2020. Medical history included gastrooesophageal reflux disease (GERD) and high cholesterol. Concomitant medications included omeprazole, colestyramine (QUESTRAN), and vitamins. On 22Dec2020, the patient was not feeling well intermittently starting the day after the injection with warm sensation in chest that would go away until 31Dec2020 when the warm sensation of chest would not go away. The patient was sent for EKG that showed atrial fibrillation that she is now being treated for. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. Outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported atrial fibrillation and the administration of COVID 19 vaccine, BNT162B2. More information regarding the clinical course, the patient's underlying concurrent medical condition are required for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
62 2021-01-11 chills, headache Chills, Headache, Nausea, Body Aches
62 2021-01-11 headache, chills Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately... Read more
Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately 21 hours after injection
62 2021-01-11 runny nose, runny nose, throat irritation, throat irritation During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation are... Read more
During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation area, waited approximately 15 mins and then reported chest tightness, dizziness, rash and itching on her arms, fast heart rate, watery eyes, runny nose, and throat irritant. Vitals were obtained and pt was requested to wait another 15 mins for monitoring. During monitoring period, patient became to complain of increased throat irritation and new tongue swelling. Response team was contacted. During reassessment patient's symptoms decreased. Team decided patient was stable and did not require transport to the ED. Patient was monitored for another 15-20 minutes with symptoms resolving. Patient was advised to discuss reaction with her PCP prior to getting second dose of the vaccine.
62 2021-01-11 malaise, headache Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any att... Read more
Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
62 2021-01-11 body temperature increased Swollen lips, increased heart rate, temp at 101
62 2021-01-11 headache, fatigue, lethargy approximately 2 hours after my vaccination, I started with a very severe headache and felt extremel... Read more
approximately 2 hours after my vaccination, I started with a very severe headache and felt extremely tired. I had difficulty staying awake. I slept about 2 hours. When I woke up my headache was gone and I was no longer tired. I went to bed and slept well until a headache woke me up the next morning however it was not as severe as the previous night. I was a bit lethargic but not too bad. My headache continued until the evening of 1.11.21 however I was not lethargic and was able to work. Today is 11.12.21 and I feel fine. I had no injection site discomfort to speak of.
62 2021-01-11 fatigue, respiratory tract congestion, cough some congestion that just came on; her arm was really aching after the injection; she started coughi... Read more
some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
62 2021-01-12 chills, fatigue 1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itch... Read more
1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills
62 2021-01-12 headache, fatigue, chills, fever Chills, fever, severe muscle aches, headache, fatigue
62 2021-01-12 headache, fatigue Day after receiving vaccine: fatigue, fever, headache, body aches, shortness of breath, Two days af... Read more
Day after receiving vaccine: fatigue, fever, headache, body aches, shortness of breath, Two days after receiving vaccine: extreme fatigue, racing pulse, high blood pressure
62 2021-01-12 headache Dizziness, Headache, Palpitations, HYPERtension, anxiety and stated SOB Narrative:
62 2021-01-12 chills, fever, headache Fever. Chills. Headache. All my joints hurt.
62 2021-01-12 body temperature increased Tight sensation in her throat, tongue felt tingling. Temp increased to 99, blood pressure increased... Read more
Tight sensation in her throat, tongue felt tingling. Temp increased to 99, blood pressure increased to 179/99
62 2021-01-13 fatigue, headache, fever, chills Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous re... Read more
Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous report from a contactable other HCP (patient). This 62--year-old female HCP reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021at 02:00 PM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included chronic Fatigue. The patient have known allergies to Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included liothyronine sodium (T3), levothyroxine sodium (T4), progesterone, estradiol, estriol (BIESTROGEN), testosterone, colecalciferol (VITAMIN D), calcium, zinc sulfate (XINC), ascorbic acid (Vitamin C), magnesium. The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on 17Dec2020 at 10:30 AM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 10:00 PM, after the second dose, the patient experienced body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. No treatment was received for the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. The outcome of the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
62 2021-01-13 fatigue, headache I had to leave work as I was achy, fatigued and had a headache
62 2021-01-13 fatigue, chills, headache Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night af... Read more
Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night after shot. All gone by next morning with the exception of the headache, which is not as severe now.
62 2021-01-13 chills, headache, throat pain, fatigue Sore Throat , Fatigue, Chills, Pain at the injection site, headache
62 2021-01-13 fever, chills, headache, throat pain Soreness at the injection site. Chills, sore throat. slight fever. headache
62 2021-01-13 headache, throat pain, fever Soreness in the arm , sore throat Mild fever, Pain at the injection site. Headache that
62 2021-01-13 fatigue Soreness of the site then was sick 6 days later positive for COVID -19. Fatage
62 2021-01-13 chills, fatigue, headache nausea, HA, chills , fatigue after second shot
62 2021-01-13 fatigue, chills, malaise was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was f... Read more
was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was freezing; felt chills/chill became a bone chill, and she was freezing; randomly felt miserable/she felt like her body was purging/feeling "blah"; she wasn't really eating; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration in her right upper arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Vaccination Facility Type is hospital and which was not a facility. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing and it was maybe 10 years ago that she was diagnosed, and she was treated for her diabetes. There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine (within 4 weeks) or additional vaccines administered on Same Date of the Pfizer Suspect. The patient received the first dose of the COVID-19 vaccine 22Dec2020 and is due for her second dose this upcoming Tuesday, 12Jan2021. She asked if it would be safe to receive the second dose at a different time, due to personal plans. She said after she received the first dose of the COVID-19 Vaccine on 22Dec2020, she was feeling sick in Dec2020. She said she had vomiting, chills, and randomly felt miserable, fatigue from 23Dec2020. She said she was nervous about getting the second dose of the COVID-19 Vaccine on Tuesday, 12Jan2021. She said she had plans around that time period and she was afraid she was going to be sick after she receives the second COVID-19 Vaccine dose. She asked if the second COVID-19 Vaccine dose had to be administered in the timeframe that was scheduled. The patient reported she felt chilled when she woke up the next morning, 23Dec2020. She said at first she thought she felt chilled because it was cold outside. She said after she arrived at work on 23Dec2020, the chill became a bone chill, and she was freezing. She said she realized the chill was not a normal cold feeling. She said by mid-morning on 23Dec2020, she began to vomit, and went home and went to bed. She said she got sick 2 more times that day. She said she went to work on Thursday, 24Dec2020, and randomly got sick. She said she wasn't really eating at that point (Dec2020), so it was not like she got sick before or after she ate something. She said she continued to get randomly sick through holiday, 25Dec2020. She said she felt like her body was purging. She said she was feeling "blah", but she was not bedridden or out of commission. She said she had no fever that she knew of. She said her symptoms resolved right after holiday, clarifying she started to feel like herself, saying she felt good. The patient declined any treatment and reported she didn't think her symptoms were that severe, though her family wanted her to go to the doctor. There was nothing had changed in her routine prior to receiving the first dose of the COVID-19 Vaccine. Reported she had blood work every 4 months, and her last blood work was probably done in Oct2020 or Nov2020. The events did not require a visit to emergency room or physician office. The outcome of the event feeling sick, she wasn't really eating, were resolved in Dec2020, outcome of fatigue, felt chills/chill became a bone chill, and she was freezing were resolved on 23Dec2020, outcome of vomiting, randomly felt miserable/she felt like her body was purging/feeling "blah" were resolved on 25Dec2020, outcome of fear and nervous were unknown.
62 2021-01-14 fever "100.1 fever by that night, aches, pains"
62 2021-01-14 chills 2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm ... Read more
2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm site present @ this time.
62 2021-01-14 fatigue, throat irritation, nasal congestion, headache, chills Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. ... Read more
Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--
62 2021-01-14 chills, fever, malaise As per Emergency Dept note of 23 Dec 2020: "Syncope, related to getting the vaccine. Normal ECG, no... Read more
As per Emergency Dept note of 23 Dec 2020: "Syncope, related to getting the vaccine. Normal ECG, no evidence of arrhythmia, normal H/H, no evidence of ACS, CHF clinically. Normal nonfocal exam. Symptoms resolved. Home with reassurance." As per follow-up note of 04 Jan 2021: "62yo female s/p first dose of Pfizer-BioNTech vaccine on 12/23/2020 who experienced syncope, hypertension (200/100) within minutes after receiving the vaccine. She was then transported to the ED where she was given IV fluids, anti-emetic and discharged a few hours later. She reports the onset of fever, chills, anorexia, malaise, and emesis 4 hours after receiving the vaccine. The malaise, chills and anorexia persisted for 4 days at which point she started feeling better. COVID test was reportedly negative. She wants to decline 2nd dose of vaccine."
62 2021-01-14 chills, headache, cough Body aches, chills, cough, headache, nausea, soreness and swelling of L arm pit.
62 2021-01-14 fatigue Fatigue, body aches, nausea. Resolved.
62 2021-01-14 chills, fever, fatigue On the evening of the vaccine day, recipient woke up with Fever, Chills, Body aches, and Fatigue. Ca... Read more
On the evening of the vaccine day, recipient woke up with Fever, Chills, Body aches, and Fatigue. Called off of work.
62 2021-01-14 chills, fatigue, headache Patient describes chills, body aches, headache and fatigue.
62 2021-01-14 chills, headache Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due t... Read more
Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due to heart rate.
62 2021-01-14 headache, fever Second dose of Pfizer vaccine was administered too early, at day 15. Individual is reporting muscle... Read more
Second dose of Pfizer vaccine was administered too early, at day 15. Individual is reporting muscle pain, fever, and headache
62 2021-01-14 headache Severe headache lasting over 34 hours
62 2021-01-14 body temperature increased, chills She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that e... Read more
She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that evening and started having severe pain in calf of her left leg no redness ,no heat, just hurt to work 1/8/2021 She had surgery on her left leg. 2nd Covid Vaccine received on 1/12/2021 She said she had PT on her right leg with severe pain in her left calf She said she did not have any therapy on her left leg. Two ? three hours later she developed chills, temp 100.1 took temp again later is was 99. She had ultrasound that showed a large blood clot She said the PA told her the blood clot could be from receiving the Covid vaccine
62 2021-01-14 chills, fatigue Soreness with swelling and heat at injections site. Chills, Body Aches & Fatigue lasting 48hrs.
62 2021-01-14 chills, cough, headache body aches, chills, cough, headache, nausea--soreness/swelling left armpit
62 2021-01-14 headache, chills, fever chills; fever; intense body pain all over; headache; nausea; This is a spontaneous report from a con... Read more
chills; fever; intense body pain all over; headache; nausea; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 05Jan2021 17:30 in right arm at single dose for COVID-19 immunization. Medical history included hypopituitarism from an unknown date and unknown if ongoing. The patient received first dose of BNT162B2 (lot number: EJ1685), on 18Dec2020 10:45 in left arm at single dose. Concomitant medication included second dose of varicella zoster vaccine rge (cho) (SHINGRIX) for immunization, hydrocortisone acetate (CORTEF), levothyroxine sodium (SYNTHROID), desmopressin acetate (DDAVP), simvastatin, estrogens conjugated, medroxyprogesterone acetate (PREMPRO) and losartan potassium (LO). On 06Jan2021 08:00, the patient experienced chills, fever, intense body pain all over, headache and nausea. No treatment was given to the patient for the events. The patient recovered from the events in Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient received SHINGRIX within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
62 2021-01-15 headache, fever Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = ... Read more
Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.
62 2021-01-16 fatigue, malaise, headache Left sided facial numbness mildly affecting left lip, cheek and area around left eye. Lasted le... Read more
Left sided facial numbness mildly affecting left lip, cheek and area around left eye. Lasted less than an hour. Continued symptoms 48 hours after vaccine are moderate persistent headache, moderate fatigue. Feeling of not well. taking tylenol.
62 2021-01-16 chills, fatigue, headache, respiratory tract congestion, fever chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fa... Read more
chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fatigue, congestion
62 2021-01-17 headache 12/21/20 - SYMPTOMS STARTED ONE HOUR AFTER RECEIVING THE VACCINE. DIZZINESS, HEADACHES FOR 24 HRS. P... Read more
12/21/20 - SYMPTOMS STARTED ONE HOUR AFTER RECEIVING THE VACCINE. DIZZINESS, HEADACHES FOR 24 HRS. PAIN ON INJECTION SITE. TOOK TYLENOL.
62 2021-01-17 sneezing, body temperature increased, fatigue At 8:00-8:45 - started sneezing uncontrollably -it lasted until I went to bed - for about an hour - ... Read more
At 8:00-8:45 - started sneezing uncontrollably -it lasted until I went to bed - for about an hour - couldn't stop; about 8:30 I felt like I had hit a wall. Totally exhausted. Went to bed. 1:00 am woke up with a temp of 99.8. My baseline temp is 96. It lasted about 24 hours. I had temp and fatigue until 24 hours later - Friday morning. Went to work on Friday morning - so I felt better. So about 30 some hours of symptoms. Did not treat symptoms.
62 2021-01-17 headache, fever, chills, fatigue EVENING OF 12/28/20, DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, FATIGUE, AND INJECTION SITE PAIN... Read more
EVENING OF 12/28/20, DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, FATIGUE, AND INJECTION SITE PAIN. RESOLVED BY 12/30/20.
62 2021-01-17 nasopharyngitis Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right a... Read more
Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right after vaccine Full body pain daily mostly in the lower back
62 2021-01-17 headache, chills Had second injection 10 am on 1/16/21 . Woke up at 1:30 am during night on 1/17 with rigors, took ... Read more
Had second injection 10 am on 1/16/21 . Woke up at 1:30 am during night on 1/17 with rigors, took tylenol, temp in am 99.6. Had headache next day, Ok with tylenol. Woke up in am of 1/18/21, itchy all over. Looked in mirror and had hives over right side of torso in back, and on chest and abdominal area in front. Very itchy. No shortness of breath. O2 sat 96%. Took 10 mg of Atarax I had at home for allergy itching. Called our Occupational Health office, instructed to call back if worsens or unresolves in next 24 hours.
62 2021-01-17 fever I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflam... Read more
I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflammed arm over deltoid muscle that resolved after 3 days. Second dose given 21 days later- some swelling and soreness, low grade fever. Then 3 days later, I awoke, turned in bed and experienced an intense shearing pain in my neck and arm. The pain was the worst ever felt, and was not improved with NSAIDS, Acetaminophen, Hydrocodone, or Tramadol. I went to an urgent care center on 1/16 where a tentative diagnosis of sprained neck was made. The sypmptoms continue with slight improvement with steroids, and a muscle relaxant. I am concerned because I understand that covid itself can impact the nervous system considerably. I am awaiting improvement in symptoms and if none seen then I will see my primary care MD
62 2021-01-17 fever, fatigue I started running a low grade temp about 9 pm on 1/6/2021. Woke in a.m. (early) with 100.9 temp and ... Read more
I started running a low grade temp about 9 pm on 1/6/2021. Woke in a.m. (early) with 100.9 temp and swollen lymph nodes under my arm and along the side of my breast and a tingly right hand. Fever broke early am on friday (1/8/2021). I was very fatigued and tired and still had a very tingly hand on 8th. Tingly slowly got better and I didn't notice it anymore on Wednesday ,13th. Fatigue was better by Sunday the 1/9th. I felt pretty much back to normal by 11th except for my hand. No treatment.
62 2021-01-17 fever, headache, chills, fatigue ON 1/7; CHILLS, LOW GRADE FEVER (100F), BODY ACHES, HEADACHE, AND FATIGUE X 14 HRS. TOOK ADVIL - 2 T... Read more
ON 1/7; CHILLS, LOW GRADE FEVER (100F), BODY ACHES, HEADACHE, AND FATIGUE X 14 HRS. TOOK ADVIL - 2 TABS AND REST.
62 2021-01-17 fatigue, fever, headache PT received second injection on 1/13/2021 and had significant side effects following the second vacc... Read more
PT received second injection on 1/13/2021 and had significant side effects following the second vaccine. 24 - 48 hours of low grade fever, severe nausea, headache, fatigue and body aches.
62 2021-01-17 fever, headache Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:0... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:00pm (shot was at 215pm). Upon awakening 1/19 at 6:00am, arm continued to be sore and I had fever registering at 102.5. I took two Tylenol then and again at 3:00pm. Headache appeared around 9:00am and was gone by 7:00pm. Temp began to decrease at 10am, to 101.1 and was 99.3 at 2:30pm. Sunday morning woke up with no soreness in arm or fever/headache.
62 2021-01-17 throat irritation Swelling, itching, in the throat. One hive
62 2021-01-18 fatigue Body aches, fatigue, left arm soreness
62 2021-01-18 fever, chills Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going... Read more
Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going over the top half of arm around the injected area. chills , body aches, fever. stayed in bed the next 3 days. 4 day sweating, and low grade fever , fatigue very weak.
62 2021-01-18 fever, headache Pfizer -BioNTech Covid-19 Vaccine EUA After the vaccine I developed headache, low grade fever, muscl... Read more
Pfizer -BioNTech Covid-19 Vaccine EUA After the vaccine I developed headache, low grade fever, muscle ache, stiffness and nausea. This felt positive for the first 3 days until the symptoms did not leave and remained for 9 days post vaccination.
62 2021-01-18 fever, fatigue, headache, malaise, chills Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ... Read more
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
62 2021-01-18 headache Severe headache joint pain about 12-14 hts
62 2021-01-18 cough, chills fever(99), and chills,, stomach upset and diarrhea--also reporting a new cough that developed after ... Read more
fever(99), and chills,, stomach upset and diarrhea--also reporting a new cough that developed after the vaccine HX of Multiple Sclerosis
62 2021-01-19 chills, headache, throat pain, fatigue Headache, dizziness, swollen glands chin/throat sore throat and chills. Extreme fatigue. Covid tes... Read more
Headache, dizziness, swollen glands chin/throat sore throat and chills. Extreme fatigue. Covid test and ruled out.
62 2021-01-19 chills, fever, fatigue, malaise, headache Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ... Read more
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
62 2021-01-20 headache, fatigue 2 hours after receiving the COVID vaccine, I experienced the following: light headedness, dizziness... Read more
2 hours after receiving the COVID vaccine, I experienced the following: light headedness, dizziness, severe headache, rapid heart rate, high blood pressure, tightness in chest and fatigue
62 2021-01-20 headache 30 minutes after being vaccinated with Pfizer vaccine (second dose) in her right arm, employee devel... Read more
30 minutes after being vaccinated with Pfizer vaccine (second dose) in her right arm, employee developed itching and red splotching (not elevated) on her left arm. She had no difficulty breathing, no swelling and said she "felt fine" except for the itching. She took Allegra about 1:30 pm. We recommended she call her husband to come and take her home and to go to ER if symptoms progressed. She declined. At about 3:00 pm redness was improving on upper arm but had spread down to the palm of her hand. Again she stated she felt fine. Patient drove home on her own about 4 pm but agreed to text Nursing Supervisor when she got home. She reported at about 7 pm that she was greatly improved. Follow up today (1/21) itching/redness is gone but does have body aches and headache. Her only known past allergy is to Sulfa drugs. No issues with first dose. Let employee know that if there is ever a reason for another covid vaccine that she would have to have it done in the care of a doctor's office.
62 2021-01-20 chills Chills. Bodyaches
62 2021-01-20 fatigue, headache Fatigue, headache. Resolved.
62 2021-01-20 headache Since shortly after the injection she has experienced a low grade headache over her eyes and on the ... Read more
Since shortly after the injection she has experienced a low grade headache over her eyes and on the top of her head, similar to a sinus headache.
62 2021-01-20 fever, headache fever of 100.5; severe muscle and joint aches for about 24 hours; severe muscle and joint aches for ... Read more
fever of 100.5; severe muscle and joint aches for about 24 hours; severe muscle and joint aches for about 24 hours; severe headache; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: E11283), via an unspecified route of administration on 07Jan2021 06:30 at a single dose for covid-19 immunization. The patient's medical history included osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]), famotidine (FAMOTIDINE), hydroxychloroquine (HYDROXYCHLOROQUINE), escitalopram oxalate (LEXAPRO), rosuvastatin calcium (ROSUVAST) , cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took cipro [ciprofloxacin hydrochloride monohydrate] and experienced drug hypersensitivity, vioxx and experienced drug hypersensitivity, ees and experienced drug hypersensitivity. On 07Jan2021 at 18:30, 12 hours after the injection, the patient experienced fever of 100.5 with severe muscle and joint aches for about 24 hours. Then the fever subsided and had severe headache for 24 hours. All the events recovered in Jan2021.
62 2021-01-20 headache headache
62 2021-01-20 headache headache - treated with advil
62 2021-01-20 headache headache treated with advil
62 2021-01-21 throat pain, throat irritation, fatigue A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm t... Read more
A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.
62 2021-01-21 sleepiness, fatigue Extreme fatigue-unable to function-head congestion lasted approximately 48 hours slept approximately... Read more
Extreme fatigue-unable to function-head congestion lasted approximately 48 hours slept approximately 36 of those hours
62 2021-01-21 fatigue HAD FATIGUE AND NAUSEA
62 2021-01-22 chills, fever Insomnia, body aches, chills, low grade fever. I was okay by noon on Thursday.
62 2021-01-22 fever SEVERE abdominal pain, fever, nausea,
62 2021-01-23 chills, fever Starting on the 16th of Jan I became very sick to my stomach.This lasted the the AM on the 18th no o... Read more
Starting on the 16th of Jan I became very sick to my stomach.This lasted the the AM on the 18th no other syptoms present. I left work at 8:00am on the 18th with no fever ( I checked three times during the midnight shift ) I went home to bed and woke up at 6:00pm with 100.8 fever ( I never run a fever ) had fever chills and joint pain in the upper body no respiratory issues .Within 48 hours the fever was gone as well as the chills but I continued to be sick to my stomach for another two days.I wanted to report this delayed reaction because of my underlying HIV and given the fact no individuals with HIV were included in the initial study. I tested negative with the nasal swab test on the 20th.
62 2021-01-24 malaise, sneezing, fatigue, headache, fever, cough 1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing... Read more
1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing for last 10 days Still low grade fever 99.8 and cough headache body aches weakness fatigue short of breath
62 2021-01-24 body temperature increased BP at 179/99; Tongue felt tingly; felt a tight sensation in her throat; Temp elevated at 99; This is... Read more
BP at 179/99; Tongue felt tingly; felt a tight sensation in her throat; Temp elevated at 99; This is a spontaneous report from a contactable other HCP. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9231), intramuscular in left arm on 13Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. The patient had no covid-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unknown date COVID-19 immunization. On 13Jan2021 10:15, the patient experienced tongue felt tingly, felt a tight sensation in her throat, temp elevated at 99, BP at 179/99, and HR 62. No hives, no wheezing, and no angioedema. The events recovered on an unknown date in Jan2021. The patient received Benadryl 50 mg as treatment and had ice pack behind neck, laid down for 30 mins. The patient was not tested for COVID-19 post vaccination. Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
62 2021-01-24 fatigue, headache Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; ... Read more
Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
62 2021-01-24 headache Diarrhea, headache, and body aches next day, 1/15/21.
62 2021-01-24 malaise Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal f... Read more
Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal flu coming on, weak and dizzy. I felt that way for approximately 20 minutes and went lie down but began to feel more dizzy and then very nauseated. I then vomited several times and afterward began to feel steadily better. The whole even was approximately 2 hour before I felt back to normal.
62 2021-01-24 headache, chills Systemic: Rash (other than injection site), Systemic: Chills, Systemic: Generalized Body Aches , Sys... Read more
Systemic: Rash (other than injection site), Systemic: Chills, Systemic: Generalized Body Aches , Systemic: Headache.
62 2021-01-24 sleepiness, fatigue, chills Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulenc... Read more
Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
62 2021-01-24 headache, fatigue, chills arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten wo... Read more
arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten worse on day 3 post vaccine and not relieved by acetaminophen
62 2021-01-24 sweating joint pain; bad back spasms in the middle of the back radiating up through right should to right arm... Read more
joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No. Information on the Lot/Batch number has been requested.
62 2021-01-24 headache neck pain that ran up to head
62 2021-01-25 chills, fatigue, headache, fever Fever; Chills; Headache; Body aches; Extreme fatigue; This is a spontaneous report from a contactabl... Read more
Fever; Chills; Headache; Body aches; Extreme fatigue; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 10:00 in the left arm, at a single dose, for COVID-19 immunization. Relevant medical history included rheumatoid arthritis, allergic rhinitis, sulfonamide allergy, and allergy to capsicum. Concomitant medications included adalimumab (HUMIRA), hydroxychloroquine, leflunomide and other unspecified medications. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FL0140; expiry date: unknown) on 22Dec2020 at 15:00 in the left arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 12Jan2021, at 23:00 (on the same day after the injection), the patient experienced fever, chills, headache, body aches, and extreme fatigue. The patient did not receive treatment for the events. The patient was recovering from the events. The patient has not been tested for COVID-19 since vaccination.
62 2021-01-25 chills, fever Fever; Chills; This is a spontaneous report from a contactable pharmacist. A 62-year-old female pati... Read more
Fever; Chills; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient (reporter's sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Medical history included virus 3-4 weeks ago in 2020 prior to getting the vaccine. The patient's concomitant medications were not reported. The patient had the virus 3-4 weeks ago and received the vaccine yesterday (11Jan2021). She experienced fever and chills for a short time after the vaccine. The reporter wanted to know "Is that more prominent after you have had the virus? Are we getting reports of patients who had Covid 19 prior to getting the vaccine having more side effects? If since his sister got those reactions, can she be more contagious." The outcome of events was unknown. Information on the lot/batch number has been requested.
62 2021-01-25 fever, cough, headache, fatigue HA; Fatigue; DOE; Chest pressure; Fever 100.2; Sudden coughing spell; This is a spontaneous report f... Read more
HA; Fatigue; DOE; Chest pressure; Fever 100.2; Sudden coughing spell; This is a spontaneous report from a contactable Nurse (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EL3248) on 12Jan2021 18:00 at SINGLE DOSE on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history included essential hypertension (Essential HTN), cardiac output (PLR). Concomitant medication received within 2 weeks of vaccination included lisinopril. The patient previously received first dose of BNT162B2 (Lot number=EL1284) on 23Dec2020 07:00 PM at SINGLE DOSE on Left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Headache (HA), Fatigue, Dyspnea on effort (DOE), chest pressure, fever 100.2, sudden coughing spell that lasted hours during the night on 13Jan2021 06:30 AM. The outcome was Recovering. No treatment received for the adverse events. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
62 2021-01-25 fatigue ON 1/20/21 DEVELOPED FATIGUE, CONFUSION, AND VOMITING. FOLLOWED UP WITH PCP.
62 2021-01-25 chills, cough, fatigue, lethargy, runny nose, fever runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my ly... Read more
runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my lymph nodes under my injection arm became swollen and sore; my lymph nodes under my injection arm became swollen and sore; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: 0140) intramuscular in right arm on 11Jan2021 15:30 at single dose for COVID-19 immunization. She received the first dose of BNT162B2 (lot number: 0140) intramuscular in left arm on 21Dec2020 16:15 for COVID-19 immunization. Medical history included Sulfa and PCN allergy. There was no other medical history. There was no concomitant medications. There were no other medications in two weeks, no other vaccine in four weeks. The patient experienced severe body aches, chills, and fever starting approximately 8-10 hours after vaccine on 11Jan2021. These symptoms were accompanied by a runny nose and slight cough on 12Jan2021 08:00. Lethargy, very tired, no appetite also on 12Jan2021 08:00. Symptoms resolved with Tylenol, Nyquil, and one day of deep sleep. On the second day (Jan2021), her lymph nodes under her injection arm became swollen and sore. Patient is not pregnant. Events were recovered on Jan2021.
62 2021-01-26 headache, fever, fatigue Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs.... Read more
Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs. Finally back to bed to continue with violent shakes. fever, aches and head aches lasting until late Thursday afternoon. Exhausted feeling still remaining through Saturday. Felt myself on Sunday 1/24
62 2021-01-26 body temperature increased, fatigue, headache Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph ... Read more
Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph nodes left axillary area. Fatigued. Headache became debilitating around noon. Extra strength Tylenol decreased temperature and body aches but did not help with headache. Fatigued all day. 1/27/21 10amFatigued, headache, body aches gone.
62 2021-01-26 fever, chills, headache body pain/ Soreness; Headache; Fever up to 101.7; Shivers; This is a spontaneous report from a conta... Read more
body pain/ Soreness; Headache; Fever up to 101.7; Shivers; This is a spontaneous report from a contactable consumer (patient's husband). A 62-year-old female patient received first dose BNT162B2 of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on left arm on 14Jan2021 10:00 at SINGLE DOSE for COVID-19 immunization (patient is a medical worker). There were no medical history and concomitant medication. The patient noticed about 21:00 on 14Jan2021, she was having body pain and a headache. The patient's husband took her upstairs and took her temperature and she had a fever and then she got the shivers which went on for quite a while. The hot bath seemed to help. She has had no other treatment. The patient's husband stated that his wife and he both got inoculated at the local hospital. He was fine but his wife has a fever up to 101.7 and he was asking if she take ibuprofen as she has a roaring headache and she was sore. The patient has been taking baths to relieve the soreness. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer vaccine. No event required a visit to physician or emergency room. There were currently no vaccines available for the second dose, but she is planning to get the second dose 31Jan2021. The outcome of the event Shivers was recovered on 14Jan2021 and the outcome of the other events were not recovered.
62 2021-01-26 headache, nasopharyngitis, cough, nasal congestion pt states she woke up next after vax she woke up with cold symptoms, ie; stuffy nose, coughing, body... Read more
pt states she woke up next after vax she woke up with cold symptoms, ie; stuffy nose, coughing, body aches and headache. Pt states she has intermittent dizziness.
62 2021-01-27 body temperature increased, chills, fatigue Very sore arm at injection site, aching joints, 101 degree temperature with chills starting at hour ... Read more
Very sore arm at injection site, aching joints, 101 degree temperature with chills starting at hour 12 and ending at hour 23 post shot and fatigue the entire next day. 48 hours after vaccine all symptoms are gone.
62 2021-01-27 headache, fatigue approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 ... Read more
approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 97, p=101, pt reports that this bp is "normal for her", she remained alert aned oriented, progressed to feeling "flushed from head to waist", at 5:05 pm, pt feels that these s/s r/t "very busy all day,this is the first time I have sat down all day", bp 168/95, 103, spo2 96, cool pack applied to back of neck, pt reports increase in feeling , "flushed", 1720- pt c/o "my neck feels swollen, my jaw hurts", denies shortness of breath, or chest pain, no hives observed on head, or abd, pt agrees to more advanced eval at ER, husband notified, 1730, pt experiences dry heaves, no emesis, bp 179/109, Ambulance called to transport to ER, IV initiated by EMT, 1740, pt to stretcher, with ambulance crew, report given, pt continues to deny shortness of breath, and chest pain, she remains alert and oriented.
62 2021-01-27 chills, fever, malaise, headache migraines; arm is sore where the injection; she could hear like blood going through her, and if she ... Read more
migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.
62 2021-01-28 fever, chills Chills; fever; This is a spontaneous report from a contactable nurse (patient). A 62-year-old femal... Read more
Chills; fever; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date unknown) via an unspecified route of administration in the right arm on 07Jan2021 at 8:30 AM at a single dose for for COVID-19 immunization. The patient medical history was not reported. The patient has not had COVID prior to vaccination. Concomitant medications included doxycycline, lisinopril, thyroid, ubidecarenone (COQ10 [UBIDECARENONE]) on unspecified dates for unspecified indications. The patient previously took EES (erythromycin ethylsuccinate) and experienced allergies, and previously received the first dose of BNT162B2 on 17Dec2020 for COVID-19 immunization. The patient had no other vaccines in four weeks. 07Jan2021 at 20:00, the patient experienced chills and fever. It was reported that patient missed three days of work. It was unknown if treatment was received for the adverse events. The outcome of events was recovered on unspecified date in Jan2021.
62 2021-01-28 fatigue, headache Headache, HYPERtension, FATIGUE Narrative: PATIENT HOSPITALIZED OVERNOC w/HTN urgency. patient late... Read more
Headache, HYPERtension, FATIGUE Narrative: PATIENT HOSPITALIZED OVERNOC w/HTN urgency. patient later seen by PCP endorsing improvement of symptoms. pt further endorsed feeling lightheaded with vaccination # 1. pt also with c/o increased burping.
62 2021-01-28 chills, headache When she woke up at 1/28/21 had the general body aches, headache, and chills. Then today that has r... Read more
When she woke up at 1/28/21 had the general body aches, headache, and chills. Then today that has resolved, but is having a stabbing, throbbing head pain in one spot. Had been taking regular Tylenol but took Tylenol with Codeine as it is limiting her to what she can do. Had trouble sleeping last night due to it. Just hoping that it goes away.
62 2021-01-28 chills, fever, malaise, headache headache, chills, fever 101, malaise
62 2021-01-28 malaise shaking, dizziness, felt bad right after injection
62 2021-01-29 throat irritation Patient is a 60-year-old female with past medical history of HTN, SLE presents emergency department ... Read more
Patient is a 60-year-old female with past medical history of HTN, SLE presents emergency department with throat itching after receiving the COVID-19 vaccination. Patient states that she previously had allergic reaction to contrast dye in the past and is having a similar sensation in her throat. She admits to nausea but denies any voice changes, difficulty swallowing, wheezing, rash. Patient denies requiring admission recommendation from allergic reaction past. Patient received Allegra prior to receiving the vaccination. This is her first dose of the vaccination.
62 2021-01-29 headache, fatigue, fever, chills injection side pain, tiredness, headache, muscle pain, chills, joint pain, fever
62 2021-01-30 headache, chills Chills with uncontrollable shivering, headache, body aches and joint pain
62 2021-01-30 fever, nasal congestion, fatigue Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose... Read more
Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose Later in evening - hives Next morning - swollen lip on left side (had derm filler on 1/21/2021) Took Tylenol and Benadryl
62 2021-01-31 chills, influenza like illness, headache, fatigue (Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point... Read more
(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.
62 2021-01-31 headache Body aches and Headache
62 2021-01-31 throat irritation I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy his... Read more
I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy history. I was advised by the allergist to take Allegra an hour before receiving the vaccine. About 10 minutes after receiving the vaccine, I started to throat my started to feel dry and tickling, it felt like it swelling starting from the left side to the center, I started having difficulties swallowing my salvia and any fluid. My blood pressure was checked and it was elevated. I started to have difficulty breathing. They transferred me over to the ER. They gave me IV medicines Benadryl, Prednisone, Pepcid (I think). After 6 hours I was able to go home. Everything went back to normal besides the pain in the left arm at injection site. I had a telemedicine visit today with my primary care physician to follow up.
62 2021-01-31 fatigue, headache Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tired... Read more
Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tiredness
62 2021-01-31 fatigue Systemic: Anaphylaxis-Severe, Systemic: Exhaustion, Systemic: Nausea
62 2021-01-31 fever, chills, headache chills, aching, headache, slightly nauseous, low grade fever
62 2021-02-01 headache, chills Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection s... Read more
Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection site. Along with a severe headache, nausea, and chills. The symptoms lingered over the next couple of days. Contacted Employee Heath and manger the following day. Stayed out of work on 1/29/21.
62 2021-02-01 fever fever and facial swelling
62 2021-02-01 chills racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60)... Read more
racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60); Very weak; chills; whole body achiness; This is a spontaneous report from a non-contactable nurse (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176) via an unspecified route of administration on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included coronavirus and allergies: sensitive to milk protein and gluten sensitivity. Concomitant medication included St John's Wort, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium carbonate (TUMS [CALCIUM CARBONATE]) and multivitamin. The patient previously took casein and experienced allergies. On 19Jan2021 05:00 AM, the patient experienced racing pounding heart rate 110-126 (normal is 60), very weak, chills, whole body achiness. Work the night shift, 11p-7a and symptoms started around 5am. No treatment was received for the events. Patient was not pregnant. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
62 2021-02-03 fatigue, fever, headache 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headac... Read more
101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
62 2021-02-03 headache, throat pain, runny nose, fatigue Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye a... Read more
Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye and nose; burning eye and nose; weakness; tiredness; sore lips and throat; sore lips and throat; sore on tongue; chest tightness; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, high cholesterol, diabetes mellitus, allergies penicillin. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included atenolol (manufacturer unknown), losartan (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazid (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 07:00 the patient experienced dizziness, nausea, headache, constant eye and nose drain, burning eye and nose, weakness, tiredness, sore lips and throat, sore on tongue, chest tightness. The patient underwent lab tests and procedures which included Sars-cov-2 nasal swab test: negative on 19Jan2021. The outcome of all events was not recovered as all ongoing now for 1 week. The events were considered non serious. Information on the lot/batch number has been requested.
62 2021-02-03 fever PER MD: HIGH FEVER, TACHYCARDIA, HALUCINATIONS, CHANGE IN MENTAL STATUS
62 2021-02-03 headache Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexert... Read more
Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexertional chest ache for several hours resolved with fluids and Tylenol/motrin.
62 2021-02-03 chills, malaise, headache, fatigue chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weaknes... Read more
chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.
62 2021-02-03 headache headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consume... Read more
headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on the right arm on 10Jan2021 at 09:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730 on 20Dec2020 at 09:00 AM on the right arm for COVID-19 immunization, and Benadryl. The patient took Benadryl before the second dose and throughout the day, and it somewhat helped with the constant skin irritation. On 10Jan2021, the patient experienced headache, itchy and prickly skin all over her body. No admission to hospital involved and no treatment was received. The events resolved on an unspecified date in 2021.
62 2021-02-04 cough, productive cough Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible... Read more
Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21
62 2021-02-04 fever, headache Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, hea... Read more
Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, headache x 3 days (frontal) on Sunday developed a baseball size red, hard and warm to touch raised area around injection site. This lasted for 3 days
62 2021-02-04 throat irritation Pt stated she felt like she had a "tickle" in her throat. She was given a bottle of water. She felt... Read more
Pt stated she felt like she had a "tickle" in her throat. She was given a bottle of water. She felt as though that was helpful. She denied itchiness, shortness of breath, dizziness, lightheadedness, tachypnea, dysphagia, facial, tongue or lip swelling. She denies feeling like her throat is closing. No visible rash or urticaria noted.
62 2021-02-04 headache soreness in arm, bad headache, nausea, itching on head, face and upper body.
62 2021-02-04 headache soreness in arm, headache
62 2021-02-05 headache, malaise, fatigue Body Aches, headache, nausea, dizzy ness, feeling unwell, fatigue Pfizer-BioNTech COVID-19 Vaccine E... Read more
Body Aches, headache, nausea, dizzy ness, feeling unwell, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA
62 2021-02-05 chills, fever Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus heada... Read more
Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus headache for a couple of days, low grade fever for about 12 hours , achy all over felt like pin pricks up and down my body to the bottoms of my feet. At one point my air passage felt blocked possibly by something that I threw up.. had trouble regaining my breath. I was surprised at how fast and furious this came on.
62 2021-02-05 fever, fatigue Fever x 3 days Weakness, fatigued, achy Urinary Incontinence day 1 Brain fog
62 2021-02-05 fever fever the day after the vaccine op to 100° Fahrenheit
62 2021-02-06 throat irritation SENSATION OF BURNING OF TONGUE, LIPDS, THROAT AND NOSE WITH PAIN. EXAM FAIRLY BENIGN, NO OBVIOUS AB... Read more
SENSATION OF BURNING OF TONGUE, LIPDS, THROAT AND NOSE WITH PAIN. EXAM FAIRLY BENIGN, NO OBVIOUS ABNORMALITIES OTHER THAN MILD GLOSSITIS. TREATED WITH ANTIFUNGAL AND ANALGESICS
62 2021-02-07 headache Patient developed headache within 24 hours of the vaccination. The headache has persisted. She the... Read more
Patient developed headache within 24 hours of the vaccination. The headache has persisted. She then developed a mild erythema, mild edema, and pruritus of the palms of both hands 3 days after the vaccination. Also has pruritus of both feet but no erythema. No vesicles, ulcerations, or papules have developed.
62 2021-02-07 lethargy lethargic underarm itchy 20 minutes after injection underarm on left side developed a rash
62 2021-02-08 fatigue heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This i... Read more
heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 62 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) administered on 30Dec2020 at 01:00PM and the patient said she did not have a reaction after the first vaccine. The patient received no concomitant medications. She stated that she had no other recent vaccinations or new medications. One thing that may be important is that she did do a 7 day detox that ended the Sunday before her second vaccine dose, so her body was pretty much having no impurities in it, and she has been eating clean since then, maybe having something foreign put into her body set it off after detox. The patient experienced arm soreness and general fatigue on 21Jan2021, and on 22Jan2021 at 01:00 she experienced severe nausea and heart rate of 160 (which was reported serious as medically significant). Patient reported that after her second dose of the COVID-19 vaccine she had a significant side effect that didn't happen until 10-12 hours after getting the vaccine. She did not have a reaction after the first vaccine. After the second injection her arm was sore, and she had general fatigue. She had the second dose injected Thursday at around 01:00PM, then at one in the morning her heart rate was 160, and she had severe nausea. She was that way until 08:00AM. Her heart rate was 120 probably by 09:00AM, then came down to 100, she has never had anything like that before. Her arm soreness was a deep muscle soreness to her left arm. The fatigue was a couple hours later after she got the second dose of the vaccine. The nausea started at 01:00AM, and lasted until six to eight, she did no treatment, and it improved and is still gone now. For her heart rate of 160, she had no treatment, though she probably should have gone to the hospital, but it came down. She usually runs a heart rate of 60-70, it went back to normal Friday, probably in the afternoon on the 22nd, about 12 hours after that started. The patient stated that she feels this is medically significant for her heart rate to be that high. She had contacted her primary care physician (PCP), but they didn't call her back for 4-5 hours, by then she was fine. She doesn't think that this was treated well by her PCP, and that they should have done an electrocardiogram (EKG) and follow up labs, she is changing her PCP as a result of this. She is concerned about the people who will be getting their second dose, she has been helping with these, they have patients that are over 100, they wouldn't survive that rapid heartbeat. The outcome of arm soreness/muscle soreness and fatigue was unknown.; Sender's Comments: The reported event of heart rate increased was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
62 2021-02-09 headache, chills, fatigue Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date... Read more
Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.
62 2021-02-10 sweating, chills collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and s... Read more
collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats. After coming too, drank electrolytes and water. The patient got the chills after sweating. It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.
62 2021-02-17 headache, fever The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperatu... Read more
The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
62 2021-02-21 sweating 01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Calle... Read more
01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.
62 2021-02-21 headache RECEIVED 1ST DOSE OF PFIZER COVID 19 VACCINE ON 02/13/21. ON 02/22/21 WENT TO PROVIDER WITH COMPLAIN... Read more
RECEIVED 1ST DOSE OF PFIZER COVID 19 VACCINE ON 02/13/21. ON 02/22/21 WENT TO PROVIDER WITH COMPLAINT OF SEVERE HEADACHE AND WAS INSTRUCTED TO GO TO ER. ON 02/22/21 WENT TO ER WITH COMPLAINT OF SEVERE HEADACHE. DISCHARGE TO HOME SELF CARE IN REGARD TO FOLLOW UP WITH PCP FOR FURTHER EVALUATION SINCE DID NOT AGREE TO CT SCAN.
62 2021-02-21 throat pain The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teet... Read more
The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.
62 2021-02-22 headache, chills, sweating, fatigue, fever Fever (103+), vomiting, chills, headache, nausea, sweating, fatigue for 36+ hours.
62 2021-02-22 fatigue, headache Soreness at injection site and fatigue within several hours; headache next morning with slight dizzi... Read more
Soreness at injection site and fatigue within several hours; headache next morning with slight dizziness
62 2021-02-23 fever, headache 2/3/21: c/o Fever, headache and vomiting; 2/3/21 at 7am: Fever escalated; 2/4/21: Temp: 104; admit... Read more
2/3/21: c/o Fever, headache and vomiting; 2/3/21 at 7am: Fever escalated; 2/4/21: Temp: 104; admitted to hospital; Dx: HSV-1, Encephalitis; Tx: Acyclovir IV TID x 3 weeks, completes tx on 2/25/21 Admitted total of 6 days 2/10/21: discharged home, continues to have difficulty with computation of numbers and naming objects
62 2021-02-23 influenza like illness, headache severe headache, general flu-like symptoms started 4 hours after vaccine and lasted 36 hours
62 2021-02-24 influenza like illness I have chronic left lower quadrant pain/inflammation due to prior abdominal surgeries. My doctors ha... Read more
I have chronic left lower quadrant pain/inflammation due to prior abdominal surgeries. My doctors have told me it is scar tissue/adhesions. I have flare ups periodically. This has been going on for more than 15 years. I have not had a major flare up in more than 2 years. I received the second dose on 2.10. I had mild flu like symptoms in the next 24 hrs. On 2/16 I began to feel like I was going to have a flare up. The pain progressed to constant. It was the worst flare up of this left lower quadrant pain I have had in YEARS! I had to call my MD and ask for pain medications. I was nauseous as well. The pain slowly began to subside and by 2/23 I was back to normal. The ONLY thing different in my life has been the vaccine.
62 2021-02-24 fever low grade fever first 2 days, continued off and on nausea, dizziness and confusion
62 2021-02-24 fatigue persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat no... Read more
persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat normally; lost much weight; This is a spontaneous report from a contactable consumer reported for herself. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EM980) , on 04Feb2021 at 16:00 (at 62 years) at single dose in left arm for covid-19 immunisation . Medical history included glucose intolerance. Patient was not pregnant.Concomitant medication included atenolol and calcium/ergocalciferol (CALCIUM/VITAMIN D). The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergy. On 08Feb2021 at 08:00 (as reported) the patient experienced persistent nausea, fatigue, slight appetite loss, unable to eat normally and lost much weight, all non serious. Events were described as follows: patient had persistent nausea. The first few days she had the expected side effects of fatigue and slight appetite loss. The fatigue resolved on the second day, but the nausea become much worse on day 4. She had been unable to eat normally since then and had lost much weight that she cannot afford to lose. She kept hoping that it will go away, but it was 8 days after her shot and she still had nausea (as reported). Anti nausea medicine was administered, no treatment given for the other events. Patient recovered from fatigue in Feb2021; outcome of the other events was not recovered.
62 2021-02-25 headache body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, t... Read more
body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, thirst, shaking, feeling of crawling out of body. Lasted 3 1/2 days. Last 2 days shaking and crawling out of body feeling was not present. Diarrhea only day 1. Nausea lasted 1 1/2 days. Day 4 no adverse effects remained. Not certain if the above was related to vaccine but timing seemed to match.
62 2021-02-26 sweating For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my ... Read more
For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my temperature dropped to 93 degrees. When I finished with these symptoms my temperature climbed back up to 97.7. I have been having intermittent belly pains since then but they are nothing like they were last night and they are getting more mild and far between as I write this.
62 2021-02-27 chills, headache, fever Chills, fever, nausea, vomiting, and severe headache
62 2021-02-27 throat irritation, sneezing, nasal congestion Sneezed. Nose got stuffy. Throat felt irritated, but didn't close up. Was irritated all day. Sam... Read more
Sneezed. Nose got stuffy. Throat felt irritated, but didn't close up. Was irritated all day. Same as when I have allergic reaction to certain foods.
62 2021-02-27 fever Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with... Read more
Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with Tylenol
62 2021-02-28 fever, fatigue 4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. R... Read more
4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. Rash and itch on abdomen. Itch at injection site. Symptoms slowly decreasing over time, but not yet gone.
62 2021-02-28 fatigue, headache Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoar... Read more
Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.
62 2021-02-28 malaise, sweating, headache, chills mild headache at waking up and during the day on and off sweats on and off chills on and off feelin... Read more
mild headache at waking up and during the day on and off sweats on and off chills on and off feeling unwell as if I will get a flu or heavy cold
62 2021-02-28 sleepiness nightmares; difficulty waking up; This is a spontaneous report from a contactable pharmacist (patien... Read more
nightmares; difficulty waking up; This is a spontaneous report from a contactable pharmacist (patient). A 62-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8292), via an unspecified route of administration in the right arm on 27Jan2021 07:15 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) on 09Jan2021 04:45 PM in the left arm for covid-19 immunisation. The patient experienced nightmares and difficulty waking up on 28Jan2021 14:00 with outcome of recovered in 2021. This was very unusual for patient. Events assessed as non-serious. No treatment was received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications that patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.
62 2021-03-02 headache, fever, lethargy Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like... Read more
Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like I had a hangover; Lethargic all day; Fever 99.5-100.2; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of BNT162B2 (lot number: El9265), via an unspecified route of administration on 29Jan2021 13:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included levothyroxine sodium (UNITHROID). The patient previously took first dose of BNT162B2 (lot number: El324) at the age of 62 year-old on 08Jan2021 13:00 in the left arm and experienced minor injection site soreness. On 30Jan2021 07:00, the patient experienced headache upon waking Saturday morning and felt like she had a hangover. She felt lethargic all day. She had fever 99.5-100.2 from 7pm- 9pm on Saturday night. She experienced body aches on Sunday morning, 31Jan2021. Puttered around the house, then lost energy around noon. She felt ok but not back to normal energy level yet. Stated she is going to work tomorrow. The patient was not pregnant at the time of vaccination. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 99.5-100.2 on 30Jan2021. The outcome of the events was recovered in Jan2021.
62 2021-03-03 chills, fever 0430 AM WOKE WITH BURNING FEELING AND CHILLS. AT 0730 TEMP DONE SEVERAL TIMES. 104.9 ORALLY. CALL... Read more
0430 AM WOKE WITH BURNING FEELING AND CHILLS. AT 0730 TEMP DONE SEVERAL TIMES. 104.9 ORALLY. CALLS MADE TO CLINIC AND PCP. I REFUSED TO GO TO EMERGENCY DEPT (HOSPITAL WAS TOTALLY FULL AND SOME). ALL DAY FEVER, NEVER BROKE. SAT. 102-103 SUN. WOKE FEELING FINE.
62 2021-03-03 headache About the 11th or 12th, I noticed that the pain in my forehead- felt like little mice going up my h... Read more
About the 11th or 12th, I noticed that the pain in my forehead- felt like little mice going up my hairline into my scalp (no more into my forehead) - then over the course of the next week it moved further back onto my head. At about 05:00 am 1/21/2021, I was feeling my hairline right by the forehead and I thought I might have a lump there (there wasn't a lump there just felt like one) and I pressed on it a little bit and all of a sudden it exploded with pain and that pain lasted 23 hours. I went to regular doctor on 13th and he said it wasn't shingles and didn't know what it was. I went again on the 22nd - and she made a quick call to neurologist who said to go to ER. I wasn't in excruciating pain at this time. They diagnosed me with Trigeminal Neuralgia (1-22-2021). They gave me migraine medicine - a shot - and a prescription for anti-convulsant - Carbamazepine 200 mg twice daily.
62 2021-03-03 chills, headache, fever Chills, slight fever, back ache - lower and upper back, headache
62 2021-03-03 headache On or around December 22, I noticed pain in my left forehead as though someone had hit me with a bas... Read more
On or around December 22, I noticed pain in my left forehead as though someone had hit me with a baseball. The next week around the 29th, it got very noticeable - pain to the touch but no swelling. It continued. Between the first dose and second dose I didn't recover, it just stayed.
62 2021-03-03 fatigue, headache Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm coul... Read more
Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm. Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
62 2021-03-03 throat irritation, fever, influenza like illness, chills, headache WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, IT... Read more
WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES. ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS. THE NEXT DAY HAD A VERY BAD HEADACHE. ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS. HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION. ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.
62 2021-03-03 cough Within an hour, I started getting a dry throat and had a dry cough for a few days. A little breathin... Read more
Within an hour, I started getting a dry throat and had a dry cough for a few days. A little breathing problem - it was almost like my reaction to bees that I had before - where my throat was closing up but that was just for about an hour. The second day, I had also (three days) of really bad diarrhea.
62 2021-03-03 throat pain blue/purple/black tongue and sore throat
62 2021-03-04 headache 62 year old female complained of a headache after receiving vaccine. Onsite EMS was called vritals ... Read more
62 year old female complained of a headache after receiving vaccine. Onsite EMS was called vritals BP 166/98 100%O2 HR 98. She refused further eval and care.
62 2021-03-04 fatigue, headache, fever Developed the following approx 15-17 hours after injection: Low grade fever 100.2 Muscle and joint a... Read more
Developed the following approx 15-17 hours after injection: Low grade fever 100.2 Muscle and joint ache Fatigue Headache Took two Tylenol which brought fever down and slept. Took two more Tylenol at bedtime and felt normal the following morning.
62 2021-03-04 fatigue I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day... Read more
I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.
62 2021-03-06 malaise pt. presented to the ED at hospital with SOB, that didn't resolve with inhaler, and generally not fe... Read more
pt. presented to the ED at hospital with SOB, that didn't resolve with inhaler, and generally not feeling well. ED note attributed to the COVID vaccine
62 2021-03-07 fatigue About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and ... Read more
About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and noticed numbness/tingling in my right little finger. I went to bed and woke up at around 2:30 AM, I had very hot, stabbing, shooting pain running up and down my arm into my neck and upper shoulder. I also had pain running down my arm. This pain was a 9/10 and lasted for 3-4 hours non stop. I was up most of the night and considered going to the ED. The following day, I still had numbness/tingling in my right little finger. I was able to move my arm a little more but not enough. The numbness/tingling took 3-4 days to go away and the arm soreness took 5-6 days to go away. I received the shot from a Pharmacy Intern. I do have shoulder problems but this was not normal. I am a RN. I am very thin, weighing around 107 lbs. I wondered about the technique used or the length of the needle, or the possibility that I was allergic to something in the vaccine. I was also very, very tired for 2-3 days. I do have a sore arm after the flu vaccine but not like this. I will not be receiving the second vaccine, even though I am immunocompromised. I did call my MD office but did not go in.
62 2021-03-07 fatigue Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable he... Read more
Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6201), via an unspecified route of administration on 05Feb2021 at 08:15 on the left arm at a single dose for COVID-19 immunization. Medical history included sleep apnea from an unknown date and unknown if ongoing and meningioma removal on an unspecified date, 3 years ago. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rapid heart beat, jitteriness, fatigue and sore arm on 05Feb2021 at 10:00. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
62 2021-03-07 headache, chills, fatigue Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chil... Read more
Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chills, muscle and joint pain, headache, tiredness
62 2021-03-08 fatigue, chills Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my ... Read more
Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.
62 2021-03-08 sneezing Next day repeated sneezing all day every 5 minutes 2 sneezes; This is a spontaneous report from a co... Read more
Next day repeated sneezing all day every 5 minutes 2 sneezes; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration, in the right arm on 05Feb2021 at 10:00 AM (at the age of 62-years) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included liraglutide (VICTOZA), metformin, lisinopril, bupropion hydrochloride (WELLBUTRIN), rosuvastatin calcium (COLESTRAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021, the next day after vaccination, at 2:30 PM, the patient had repeated sneezing all day every 5 minutes 2 sneezes. No treatment was given. The clinical outcome of the sneezing was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
62 2021-03-09 chills, fever, headache fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 62-ye... Read more
fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. El3428, via an unspecified route of administration (right arm) on 03Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included acid reflux and known allergies to erythromycin and azithromycin (ZITHROMAX). No covid prior to vaccination. Concomitant medication included lansoprazole. The patient previously first dose of BNT162B2 (brand=Pfizer) for COVID-19 immunization on 15Jan2021 03:15 PM (lot no. El3428, right arm). No other vaccine in four weeks. On 04Feb2021 09:00 AM, the patient had fever and chills and headache on Thursday and Friday after her vaccine. No treatment received for the events. No covid test post vaccination. The patient recovered from all events on 05Feb2021.
62 2021-03-11 headache, cough Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeli... Read more
Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeling of bugs crawling in her lungs, bugs front and back/ painful cough; itching; This is a spontaneous report from a contactable nurse. This case was also received from Pfizer sponsored program. A 62-year-old female patient received the 2nd dose (at the age of 62-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration in Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included lung and back problems (back pain). It was reported that the patient normally took an inhaler (not steroid inhaler because she didn't want to interfere with immune response), and other things. The patient previously took prednisone which started at 40mg for 2 days, 30 for 2 days, 20 for 2 days then goes down to zero for back pain (stopped taking 4 days before the second dose of the vaccine). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot# not provided) on 29Jan2021 (at the age of 62-years-old) for COVID-19 immunization. The patient's 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE was administered a week ago (Feb2021) Friday. It was reported that she got very ill initially which she said joint pain in hands and headache noted in Feb2021 (Saturday) which wasn't so bad. On Saturday afternoon, she reported shortness of breath, coughing with extreme pain (painful cough) and described a feeling of bugs crawling in her lungs, bugs front and back, and itching, and no one else reported it. The patient kept sleeping and waking up, thinking she was alright, but the coughing and lasted until Sunday evening, it was a very painful cough, and a creeping sensation in lungs front and back. She missed work on Monday. The events (joint pain in hands, headache, shortness of breath, coughing with extreme pain (painful cough) and itching) were medically significant as she was unable to go to work. It was also mentioned that since the patient stopped taking the Prednisone 4 days before the second dose of the vaccine. The patient had an exacerbation of pain (it came back). The patient was also wondering when can she start the inhaler and steroid for the back as she has lung and back problems. Outcome of the events were unknown. Information on lot number/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reviewed upon receipt of further information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
62 2021-03-13 influenza like illness, throat pain 2 weeks after receiving the 2nd dose, do you feel loved left neck had an apathy and sore throat, ha... Read more
2 weeks after receiving the 2nd dose, do you feel loved left neck had an apathy and sore throat, had pharyngitis laryngitis was seen by knee urgent care hand emergency room hand tested negative for Covid and strep. Developed left vocal cord paralysis and constant flu like symptoms that have lasted for six weeks. My vocal cords will mean to me injected need to paralysis
62 2021-03-17 fever tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertip... Read more
tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
62 2021-03-18 body temperature increased Patient was found in house by EMS with agonal respirations. Patient was intubated on scene and broug... Read more
Patient was found in house by EMS with agonal respirations. Patient was intubated on scene and brought to ER. At ER, patient presented with a HR of 55, BP of 80/43, O2 of 99%, and a rectal temperature of 107.3F. Further work-up revealed thrombocytopenia with a platelet count of 63, WBC of 13.7, and an elevated lactate of 2.2. Imaging shows a kidney stone obstruction of the right ureter. Diagnosis of sepsis was made with patient admitted to the hospital. Repeat rectal temp after acetaminophen suppository and external cooling continues to be 107. Care is ongoing at time of this report.
62 2021-03-21 fever cellulitis; lymphadenitis; Fever 103; Still swollen from groin area down to knee; This is a spontane... Read more
cellulitis; lymphadenitis; Fever 103; Still swollen from groin area down to knee; This is a spontaneous report from a contactable other HCP (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: not reported), via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 PM at a single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications were none. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient experienced fever 103 white posture on knee that turned into cellulitis and lymphadenitis. The patient had IV antibiotics twice within 5 days of vaccine as treatment for events. The patient still had swollen from groin area down to knee. AE resulted in emergency room/department or urgent care. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was not recovered. Information on the batch/lot number has been requested.; Sender's Comments: The event cellulitis is assessed as unrelated to BNT162B2 based on the information provided. The event onset date is not reported, therefore the drug-event temporal relationship is not clear. In addition, the BNT162B2 vaccine was administered in the arm but the reported cellulitis was at knee area. It is very unlikely that the cellulitis was related to BNT162B2.
62 2021-03-23 throat irritation, lethargy Within 30 min of shot, starting feeling itchy tongue and throat. Drank water and within a few minut... Read more
Within 30 min of shot, starting feeling itchy tongue and throat. Drank water and within a few minutes got a full body heat flush and starting shaking all over. Heart beating fast and having some pain in chest. Drove to her work place and was assessed by MD and RN on staff. BP was 220/120, pulse over 100. She took a Claritin and was monitored in the work place. She became lethargic and chest pain continued so she went to the closest Emergency Room.
62 2021-03-24 nasal congestion rash; hives; swollen face; congestion; This is a spontaneous report from a contactable consumer (pat... Read more
rash; hives; swollen face; congestion; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an specified route administered in Arm Left on 14Feb2021 10:30 AM at single dose, second dose via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Batch/Lot Number: ENG199) as SINGLE DOSE for covid-19 immunisation. Medical history included avn (left hip and both knees replaced), Known allergies: Bee stings, Cats. No covid prior vaccination. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT). No other vaccine in four weeks. The patient experienced Slight reaction from first shot: Rash, hives, swollen face, congestion. 10Mar2021 10:00 PM, the patient experienced same events after the second dose, resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalized for 1 day. The patient tested Covid post vaccination on 11Mar2021: Nasal Swab with Negative result. The outcome was recovering.
62 2021-03-25 malaise Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; l... Read more
Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; little pain in her left arm where the vaccination was given; pain in her elbow; seems like her left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (lot number: EN6202 and expiration date: 30Jun2021) as 0.3 mL, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Vaccine last Friday (05Mar2021) and on an unknown date, she had little stiffness in her arm and she was "not feeling very" (incomplete sentence), you know she was just felt little off but other than that, not too bad. The patient also had a little pain in her left arm where the vaccination was given and some stiffness on unknown date. Since then, she had pain in her elbow on left arm and today (10Mar2021), the pain was pretty persistent and seems like her left arm was swollen. The patient also stated "I guess I should say, I have rheumatoid arthritis" (pending clarification)". The patient received treatment for the events, stated "The only thing I took in this morning is Tylenol." Outcome of the events was unknown.
62 2021-03-29 body temperature increased diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 ... Read more
diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 - 99.4; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Mar2021 09:30 (lot number: EN6204) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, migraines, and thyroid disorder. The patient's concomitant medications included cyclobenzaprine, levothyroxine, telmisartan (TELMI), and topiramate (TROKENDI XR). The patient previously took erythromycin and morniflumate (FLOMAX) and experienced allergies to both. The patient experienced severe stomach cramping, diarrhea with bright red blood, extreme nausea, back cramps, temperature range 97.4 - 99.4, so sick and she had to lay on bathroom floor throughout night on 10Mar2021 20:00. There was no other vaccine in four weeks. The patient was not pregnant at the time of report. Prior to vaccination, patient has no COVID and patient was not tested for COVID post vaccination. The vaccination facility type was Health Department. The outcome of the events were recovering.
62 2021-04-05 headache patient had headache within the first 15 minutes after administration and was found to be positive f... Read more
patient had headache within the first 15 minutes after administration and was found to be positive for dural venous sinus thrombosis with unknown etiology
62 2021-04-06 headache On 2nd day after 2nd vaccine, I felt bad and began to have headaches. On about day 8, I began to hav... Read more
On 2nd day after 2nd vaccine, I felt bad and began to have headaches. On about day 8, I began to have ear ringing along with headaches. It has been 36 days now. The headaches are still present but somedays not as severe. The ear ringing is 24/7 now and extremely annoying. Nothing I do will make it better.
62 2021-04-09 malaise I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; F... Read more
I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
62 2021-04-09 headache, fever fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pi... Read more
fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pictures that were kind of ridiculous and seeing things; Severe headaches; Heard a lot of noises in head; body hurting severely where she couldn't walk; body hurting severely where she couldn't walk; no appetite; nauseas; This is a spontaneous report from a contactable healthcare professional (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left, at the age of 62-year-old, on 18Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Oct2020. The patient's concomitant medications were not reported. The patient previously received flu shot as immunization and did not get any reactions and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) on 28Feb2021, single dose for covid-19 immunisation and experienced very achy, some fever, some diarrhea, one episode and a big headache, difficulty Sleeping, and intense sensations. The patient experienced severe side effects/ bad reactions three weeks after receiving the second dose of vaccine. The patient experienced visual pictures that were kind of ridiculous and seeing things (medically significant) on 19Mar2021 with outcome of recovered on 21Mar2021, severe headaches (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, heard a lot of noises in head (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, body hurting severely where she couldn't walk (non-serious) on 18Mar2021 with outcome of recovered on 21Mar2021, fever (non-serious) on an unspecified date with outcome of recovered on 21Mar2021, diarrhea (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, in tears from intensity of the sensation second half of the day after receiving Pfizer Covid Vaccine (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, no appetite (non-serious) on 18Mar2021 with outcome of unknown, nauseas (non-serious) on 18Mar2021 with outcome of unknown, feeling out of body experience (non-serious) on an unspecified date with outcome of unknown. The diarrhea was reported as much more intense. The patient doesn't know how else to describe it, except it was very intense and severe. No appetite and nauseas which lasted 2-3 days, it's almost like feeling out of body experience. The events did not require a visit to Emergency room or Physician office. The patient did not receive vaccination within 4 weeks prior vaccination. No relevant tests performed.; Sender's Comments: Based on the close temporal relationship, the association between the event "seeing thingis" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
62 2021-04-10 chills 2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days... Read more
2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days also then had chills hand tremors loss of appetite nausea this continued for 2 more months. I went to Urgent care and on March 26 then found a clot in my right lung. I am on warfin now and none of these symptoms did I have prior to the vaccine. I had 5 covid tests to see if I had COVID but all the tests were negative.
62 2021-04-11 malaise Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19... Read more
Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19, then found obtunded due to pulmonary embolus resulting in death within 24 hours of receiving 2nd dose
62 2021-04-13 headache Slight headache that day (4/1). The next day (4/2), weakness in left leg and arm. On 4/3 went to ER... Read more
Slight headache that day (4/1). The next day (4/2), weakness in left leg and arm. On 4/3 went to ER, admitted to NeuroScience ICU. Diagnosed with small blood clot and small bleed in brain--- dural venous sinus thrombosis. The neurology team said this was very unusual and very rare in this part of brain--where the blood flows back to the heart from the brain. They did alot of tests on every part of my body looking for the cause and found nothing. They think it was vacine induced and repoted it to the CDC. Left leg and arm weakness remains with no changes yet. Now taking blood thinner and doing physical therapy
62 2021-04-15 fatigue fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis sy... Read more
fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis symptoms and GERD
62 2021-04-17 throat pain, fever, headache eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy ... Read more
eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
62 2021-04-17 nasopharyngitis passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs... Read more
passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.
62 2021-04-19 fatigue, malaise Information obtained from the Hospital. Began to not feel well the next day, SOB, diarrhea and fatig... Read more
Information obtained from the Hospital. Began to not feel well the next day, SOB, diarrhea and fatigue. Was admitted to hospital on 4/9/21, diagnosed with COVID, placed on a vent and died on 4/19/21.
62 2021-04-23 fatigue, headache -Patient died unexpectedly on Thursday, April 22, 2021 at her home (found unresponsive by spouse) -N... Read more
-Patient died unexpectedly on Thursday, April 22, 2021 at her home (found unresponsive by spouse) -No reactions were observed at the pharmacy (within 15 min waiting period) following either covid-19 vaccine (1st dose administered 8am on 3/26/21 -Left Deltoid) -When asked (4-16-21) how she tolerated the 1st dose, Patient reported minor side effects (mild Headache, tiredness) but had no reservations about receiving the 2nd dose. No additional information.
62 2021-04-23 fatigue, headache Tiredness; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient)... Read more
Tiredness; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6201), via an unspecified route of administration in left arm on 11Feb2021 at 17:45 as single dose for COVID-19 immunization. The medical history of patient was included asthma, high blood pressure, obesity, allergies from Penicillin. Patient did not receive any other vaccine in four weeks. The concomitant medications of patient included triamterene, trazodone, citalopram and potassium (Other medications in two weeks). On 12Feb2021 at 06:00 AM, patient experienced tiredness, headache, muscle ache. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient did not receive any treatment. The outcome of event was recovering.
62 2021-04-24 fever, fatigue, chills She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking,... Read more
She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking, she thought she was having a seizure with how bad she was shaking; Chills; Fever; sore hands and wrists; sore hands and wrists; totally exhausted; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 15:00 (Lot Number: EPT533) as single dose for covid-19 immunisation. The patient previously took flu shot. Medical history included diabeticc, thyroid is done, real bad psoriasis, high blood pressure, triglycerides, cholesterol , anxiety, to replenish potassium. Concomitant medications included metoprolol taken for hypertension; acetylsalicylic acid (ASPIRIN (E.C.)); citalopram taken for anxiety; amlodipine taken for blood pressure; hydrochlorothiazide; fenofibrate taken for blood triglycerides; atorvastatin taken for blood cholesterol; losartan potassium to replenish potassium; colecalciferol (VITAMIN D3); metformin taken for diabetes mellitus; levothyroxine; hydroxyzine; guselkumab (TREMFYA) taken for psoriasis,. The patient was shaking, she thought she was having a seizure with how bad she was shaking, chills, fever, sore hands and wrists, totally exhausted, diarrhea on 01Apr2021. The outcome of events chills, Wrist pain, Pain in hand was recovered on 05Apr2021; The outcome of event Fever and Diarrhea was recovered on 06Apr2021; outcome of other events was recovering.
62 2021-04-24 chills, sweating, dehydration cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose;... Read more
cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose; cold sores on lips after second dose; threw up after second dose; soreness after second dose; dizzy and weak after second dose; dizzy and weak after second dose; chills after second dose; sweating after second dose; dry heaving after second dose; nauseated after second dose; dehydrated after second dose; hasn't eaten for 5 days after second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FR8737and expiry date was not provided), via an unspecified route of administration, in left arm, on 07Apr2021, as a single dose (at the age of 62-years) for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection, lot number: EN6201 and expiry date was unknown), via an unspecified route of administration, in left upper arm, on 05Mar2021, as a single dose for COVID-19 immunization. The patient arm hurt after first dose (began immediately and lasted for about 4 days) which was resolved on 09Mar2021. Patient second dose was scheduled on 27Mar2021, but she did not get it till 07Apr2021. It was reported that on 08Apr2021, patient had such an awful reaction to the second dose of the vaccine. She started to get dizzy and weak, chills, everything was a blur, sweating, could not drink threw up if she tried dry heave went back to sleep and slept for 48 hours had just chills the whole time. She was in bed sleeping trying to drink, getting up to go to the bathroom and feeling like she was going to die for the next three days. She was nauseated and is still nauseated and could not drive. She took Tylenol an antiemetic at urgent care that stopped. She took Zofran with the saline solution infusion and she went home and slept. She was dehydrated and had soreness all over. On 09Apr2021, she could not roll over and had a sore on her left butt cheek that was still there cold sores on lips. She thought the sore on her left butt cheek came from laying in bed so much, and it was not in any other space but that one spot almost like she would have gotten the shot there, but she didn't. On 10Apr2021, patient felt like she was going to die, and went to urgent care and asked if they could give her fluids. They gave her fluids and Zofran and that helped a lot. This one shocked the hell out her, she thinks it was her gums that started to bleed on 11Apr2021. She had the best oral hygiene and went to the dentist all the time. She was flosses like crazy. She started to drink a ton of water and has not seen it since. She cannot guess what the reason was. On 11Apr2021, she could function a little and had chills again last night and sweating. She did not have a fever. She ate chicken noodle soup water and a little bit of ginger ale. She started to feel better, but not 100% better not even 90%, not even 80%, but was heading towards the right direction. Patient also hasn't eaten for 5 days after second dose. She experienced cold and hot. She was not complaining at all and she has been sick for days and cannot eat and will throw up but will gain it right back. The dizziness and weakness were subsided. She feels like she is getting beat up but is recovering. Patient thought that vaccine pulled out with a syringe and that's the problem everyone gets the same dose. Patient's weight was 136 or 138 lbs. Outcome of the events nauseated after second dose was resolved on 10Apr2021, and dizzy and weak after second dose was resolved on an unknown date in Apr 2021, and for the events chills and sweating it was recovering, and for all other events, it was unknown.
62 2021-04-26 headache had a stroke after getting the Pfizer vaccine; weakness left arm and left leg; Headache; Dural venou... Read more
had a stroke after getting the Pfizer vaccine; weakness left arm and left leg; Headache; Dural venous sinus thrombosis; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 62-years of age) dose 2 via an unspecified route of administration, administered in arm right on 01Apr2021 10:20 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation (to not get Covid). Medical history included ongoing multiple sclerosis which was diagnosed back in the early 90's and the doctors saw no new reasons on any part of the MRI of the brain, neck, and spine, there were no new lesion and she has had no problems for 30 years; and she had sinus pressure. There were no concomitant medications. Historical vaccine included BNT162B2 (Batch/lot number: EN6208) dose 1 in her left arm on 11Mar2021 (at 61 years of age) for COVID-19 immunisation. It was reported that the patient had a stroke after getting the Pfizer vaccine. She stated that she was in the ICU for 3 days. They tested every part of her body and couldn't find a reason. She added that she had a clot in her brain with a small bleed and they told her it was highly unusual to happen in that part of the brain. It was stated that it was where the blood goes from the brain to the heart. She mentioned that it was a dural venous sinus thrombosis. She was in the neuroscience ICU for 3 days and her left leg and left arm are still weak and she will start PT. She wanted to talk about reporting and let us know this was happening and that the neuroscience team reported it to the CDC online while she was in the hospital. She wanted to talk about her concerns and see if we are seeing this with other people. She added that she was tested, and they found nothing. She mentioned that she got the vaccine in a Thursday morning and by Friday she had weakness in her left arm and left leg and a headache. She added that there was a high probability that it was related, that it was a new vaccine and it was hard to say it definitely happened from that but it was a high probability. She had other questions, she has heard from other people with other vaccines and people with Covid experience blood clots. She stated that she was wondering what if it was with the vaccine that is reacting to what it thinks is Covid, or is it the body's response. She was wondering if Pfizer comes out with a booster with the variant, should she not take the booster. She stated that it could have killed her if they had not caught the blood clot in her brain and had she not gone to the ER it could have killed her and she was concerned about taking a booster. She provided that she had the Pfizer vaccine on 01Apr2021 in the morning and had a headache that same day and who knows when on Friday morning she had weakness in her left leg and left arm, so within 24 hours. She provided that she went to the ER Saturday 03Apr2021, that she wasn't sure about it and you don't go running for everything. Stated she was admitted 03Apr2021 and was discharged 05Apr2021 or 06Apr2021. She clarified that her headache was totally gone, that she had sinus pressure that was not related and had it as a constant in her life, it was normal for her and happens with changes with the weather. The patient was hospitalized for had a stroke after getting the pfizer vaccine (cerebrovascular accident) from 03Apr2021 to 06Apr2021. The patient underwent lab tests and procedures which included blood work constantly, CAT scan of her torso, several CAT scans of her brain, had MRI's and CAT scans constantly, brain MRI, MRV of the brain all on an unknown date with unknown results. The events resulted from Emergency Room Visit. The outcome of headache was recovered on an unknown date while not recovered for weakness left arm and left leg. The outcome of other events was unknown. Information on the lot/batch number has been requested.
62 2021-04-27 cough I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got li... Read more
I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine.; she can't talk, it's closing up her throat,; she can't talk, it's closing up her throat,; taste sodium in my mouth constantly; coughing; got home and I've been sick ever since.; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration administered on right arm on 07Apr2021 at 13:30 (at the age of 62-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing Allergies with This was under control, ongoing asthma with This was under control, meniere's disease from 1989 and ongoing with This was under control, have 2 broken knees. Patient knows how to control this condition, she didn't need Prednisone prior to onset of these adverse events, Low immune system with She has an immune deficiency so her immune system very low, like 300., Respiratory illness, Genetic/chromosomal abnormalities, Endocrine abnormalities with endocrine abnormalities (including diabetes) and obesity. Family Medical History Relevant to AE reported as None. History of all previous immunization with the Pfizer vaccine considered as suspect reported as Both doses of product documented in Pfizer Suspect Vaccine and Vaccination fields. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207; Expiry date: 31Jul2021) via an unspecified route of administration to the right arm on 13Mar2021 at 13:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine other than dose 1 of 2 of the Pfizer-BioNTech Covid-19 Vaccine. Regarding concomitant products and other medical conditions patient reported none other than just her inhalers which doses of had to be increased in response to symptoms after first and second doses of Pfizer-BioNTech Covid-19 Vaccine. Concomitant medication included tiotropium bromide (SPIRIVA) taken as Dose increased to twice in the morning daily for an unspecified indication from an unspecified start date and ongoing, (Lot number: 0014678, ; Expiration Date: Jan20230); fluticasone propionate, salmeterol xinafoate (ADVAIR) 500 taken as Dose increased from once daily to twice daily an unspecified indication from an unspecified start date and ongoing; azelastine hydrochloride (Lot Number: 3N2E, Expiration Date: Feb2022), fluticasone propionate (DYMISTA) taken for an unspecified indication from an unspecified start date and ongoing (Lot number: GA00510, Expiration date: May2022); prednisone (PREDNISONE) taken for an unspecified indication with quantity of 27, Dose: 3-20mg daily for 7 days, then 2-20mg daily for 2 days, then 1-20mg daily for 3 days and Ongoing therapy. She also used a nose spray that didn't work so they switched her back to Dymista nose spray. Consumer stated that she received both doses of Pfizer's COVID vaccine and had reactions to both of them. Consumer stated that, "The second dose was even worse. They put her on Prednisone. She did not know if she should be tested again or not? She was sitting up but she could not walk around anywhere. She had 2 broken knees. She could not walk anywhere. After the second dose, they had to bring her to the hospital because she couldn't even walk to her car. She got home and she had been sick ever since. She had allergies too. She could not do anything. she had a hard time breathing. she was hesitant to get the 2nd one, but everybody said to get it. Her IgG level was down to 300 something. She was also tapering off of prednisone and she did not want to be tapering off it because it was worked well for her. She could tell by her breathing that it was helped her. She could taste sodium in her mouth constantly since she had got the vaccination." Second dose completed her prescribed therapy. Dates for Symptoms From 15Mar2021 to Ongoing Reported seriousness for Symptoms reported as Unspecified and the Symptoms was reported as worsened. Patient's doctor dropped her last week, told her she didn't know what to do with her, and that this was too stressful. Onset of symptoms following first dose of Pfizer-BioNTech Covid-19 Vaccine was on 17Mar2021. She couldn't breathe very well when she went in for the first dose of Pfizer-BioNTech Covid-19 Vaccine. She was ok the first day after the first dose of Pfizer-BioNTech Covid-19 Vaccine, seemed ok, arm didn't hurt; but then had onset of symptoms. She has been in bed the whole time since onset of symptoms, was in bed for over 2 weeks. She slept for 2 days straight, only got up for water and the bathroom. It was bad, getting hard to breathe. She had to use her emergency inhaler. The Pfizer-BioNTech Covid-19 Vaccine messed up her Meniere's disease. Doctor started patient on Prednisone for these symptoms, and Prednisone is really the only thing that clears up Meniere's disease because her ears was full and she could not get up. Prednisone helped her and I relayed in her 'rescue' inhalers (treatment) because she did 2 in the morning, two inhalers anyway when she started to feel better, she got her second one and it made her worst. She did not eat anything salty or anything, the barometric pressure was not bad. It was really funny because she had just finished everything and it was a few days before she had to go get her second dose of Pfizer-BioNTech Covid-19 Vaccine shot. She was just starting to feel normal, at least normal for her, she could get up normal and drive. They gave her the second shot of Pfizer-BioNTech and it was like a double. She clarified as she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tasting sodium in her mouth from the Pfizer-BioNTech Covid-19 Vaccine. She can't have much sodium which struck up the Meniere's disease really bad the second day after the second dose of the Pfizer-BioNTech Covid-19 Vaccine; her allergies in her head went bonkers. She could not talk, it was closing up her throat, she was coughing every time she eats or dinks, and she's having a "really bad" adverse reaction to the Pfizer COVID-19 vaccine after the second dose. They had to take her out of the hospital to her car in a wheelchair "right after" getting the second shot. She could not get more than 1000 mg of sodium a day, she tastes it in her mouth constantly, she could not get rid of it and it was "going through her system". She wanted to know what to do, since her doctor told her to contact Pfizer. She wanted to know what part of the vaccine is doing that, she assures it is sodium, because sodium is in her mouth 24/7 and she could not get it out, she could not have that much sodium in her body. It was still getting really hard to breathe. She is still taking the Prednisone she was initially prescribed and started on for the symptoms that started after her first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tapering off of Prednisone, and she shouldn't be tapering off, she thinks she needs to be Prednisone for some more days, maybe 3 more days, then she would be ok. It was prescribed as a 7-day burst of Prednisone. She mentioned that the only Prednisone that works on her is the Actavis manufactured Prednisone; her pharmacy orders it for her because they know that. She called the emergency room Saturday when she was really bad. They said they had a line there and it was going to be at least a 4 hour wait. With patient's low immune system, Meniere's disease and that she could hardly breathe she did not go to the emergency room because she could catch something and die while waiting. She decided she would just stay at home and rest. She has not had any Physician's office visit relative to event; she has a telephone appointment tomorrow to see if the doctor is going to be her doctor. She had to cancel her appointment with the doctor today because if she has something she doesn't want to spread it, she feels worse now and with the Meniere's she is tasting sodium in her mouth constantly from the Pfizer-BioNTech Covid-19 Vaccine, she does not eat a lot of salt. The flu shot takes her a couple of days, then she is right back up and Vaccination Last dose on Oct2020. Consumer stated that she has 'Meniere's' disease (History) and it made her worse. The patient underwent lab tests and procedures which included IgG level: 300. Reporter stated the seriousness for the events was Unspecified. Seriousness of event Meniere's disease aggravated was medically significant. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
62 2021-04-27 malaise, influenza like illness, headache, chills My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. T... Read more
My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. The following morning at 7:00 am, Patient said that she felt real sick. She also, complained of having a real bad Headache, Not long after that, she felt like throwing up. She tried to throw up. Except, nothing came out and she felt very nauseous because of the vaccine. When she came call to bed, I offered to make her some breakfast to help her feel better. Unfortunately, she felt, too, I'll to try and eat an food because of the way she felt. So, I laid next to her with the hope that all would be well. Because, the pharmacist who administered the second dose. Assured my partner, that it was normal to feel flu like symptoms the next day. So, we never doubted what the pharmacist advised. All of sudden, she suffered a cardiac arrest in my presence and died in front of me.
63 2021-01-01 throat irritation Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively... Read more
Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively got worse and I felt throat swelling and my voice was effected. No itchy throat like my anaphylaxis reaction to shellfish only swelling. I mildly panicked and wanted to take Benadryl. About 1/2 hour later by the time I got home reaction was over. No repeat of symptoms ever again.
63 2021-01-04 chills, fever 6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she start... Read more
6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she started to have abdominal pain which worsened over the course of the day to excruciating. She went to the Emergency Room where a CT scan revealed a perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening of 1/3/2021.
63 2021-01-04 fever, headache, chills Fever of 99.7 on 12/30/2020 Fever of 100.3 on 12/31/2020 Debilitating headache Chills
63 2021-01-04 body temperature increased, fatigue significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized i... Read more
significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.
63 2021-01-05 body temperature increased, headache Temperature 101, headache, ears hurt, body aches , nauseated
63 2021-01-05 fever low grade fever/fever; 100 degrees Fahrenheit/99.2 degrees Fahrenheit/99.8 degrees Fahrenheit; This ... Read more
low grade fever/fever; 100 degrees Fahrenheit/99.2 degrees Fahrenheit/99.8 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) at the public health department via unspecified route of administration at right arm on 28Dec2020 12:30 as single dose to prevent getting the Covid virus. Medical history included medication allergies (allergic to like 3 to 4 medications), allergic to sulfur/sulfa, allergic to penicillin, allergic to "-mycins", allergic to dye (for a CT scan). The patient informed that she was given the Pfizer shot, clarified to Pfizer-BioNTech COVID-19 vaccine on Monday (verified to be the 28th). The patient informed that since then she has had a low grade fever and the patient would like to talk to someone to see if that was normal, since it was still not gone. The patient got her first dose of the vaccine injected into her right arm around 12:30 PM Monday (28Dec2020), and her fever started Monday night and got to 100 degrees Fahrenheit and since then she has been running 99.2 degrees Fahrenheit (Dec2020), it was 99.8 degrees Fahrenheit now (30Dec2020). The patient stated "it didn't say on the vaccine card, but the sheet they gave with it says it is the Pfizer-BioNTech COVID-19 vaccine. All that is on there is the date she got it, 18Nov2020 and the healthcare girl put her initials on it" (unable to clarify discrepancy between the dates provided as caller continued speaking). The patient informed that she was supposed to have turned around on the 18th to get the second shot (unable to clarify statement and the caller may have meant that she was supposed to get the second dose of the shot on 18Jan2021, and misread the card as she seemed to have difficulty reading the nurse's handwriting on it). The reporter informed that the LOT number was written with an E and then either a V or a K, it looks like a V but the girl put a leg on there so maybe it was a K then 9231, or EV or 9231 or 9731. The outcome of the event "pyrexia" was not recovered.
63 2021-01-06 fatigue, fever, headache Extreme fatigue, low grade temp for 2.5 days, intermittent headaches that shifted and moved to diffe... Read more
Extreme fatigue, low grade temp for 2.5 days, intermittent headaches that shifted and moved to different areas and intensity
63 2021-01-06 headache Headache tingling hands and lips, tongue felt thick/swollen Narrative: 12/30 given vaccine in the E... Read more
Headache tingling hands and lips, tongue felt thick/swollen Narrative: 12/30 given vaccine in the ED due to a shellfish allergy for which she carries an epipen. Pt experienced mild symptoms c/w allergic reaction after receiving Pfizer COVID vaccine #1. Symptoms included tingling lips and sensation of swollen tongue. She was given Diphenhydramine 50mg PO. Condition did not progress and her symptoms resolved within about one hour of oral Diphenhydramine. She was observed for 3 hours and discharged to home with prescriptions for an epipen and benadryl. Employee states - "15 min after the vaccination my hands got tingly on the palms. 5-10 min after that the front of my lips were tingly then my tongue felt thick. I also got a headache They gave me benadryl pills in the ED and within 10 min tingling on my lips went away and my tongue felt normal. My headache also went away." She was discharged from the ED back to work and reports no other symptoms.
63 2021-01-06 chills, cough, fatigue, headache Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, c... Read more
Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency. Tested + for COVID on 1/4/21 Narrative: Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency, sees hematology. Currently taking prn tylenol, scheduled to see hematology. Tested positive for COVID on 1/4/21.
63 2021-01-06 fatigue, throat pain, headache Headache, NauseaVomiting, Sore throat,fatigue Narrative:
63 2021-01-06 body temperature increased, chills Temp of 102 with chills and body aches and pains, incision site of left ORIF became red and inflamed... Read more
Temp of 102 with chills and body aches and pains, incision site of left ORIF became red and inflamed and I had to go to the emergency room where I was given doxycycline b.i.d. for seven days.
63 2021-01-06 fatigue, malaise, body temperature increased This is a self report: two days after the vaccine I developed severe heart burn ( something I have ... Read more
This is a self report: two days after the vaccine I developed severe heart burn ( something I have never experienced). Several over the counter medication were used without relief. . The heart burn was followed by a horrible gastric disturbance. I experienced abdominal pain, cramping and rectal pain. During this time my temperature remand between 100.0 - 101.0 with fatigue and malaise. I have also noticed several welts on my body. I?m typically a very health person and have never experienced any of these experiences before.
63 2021-01-06 chills, fever, fatigue Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vacci... Read more
Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vaccination; I experienced muscle soreness at the site of injection; mild fatigue the next day (12/14/2020). After the second vaccine, I experienced increased muscle pain, with decreased ROM of the left shoulder due to pain. Within 12 hours, I experienced diffuse myalgias. After 16 hours, I experienced a fever (101F) with chills (resolved within 24 hours). There was significant fatigue the first 36 hours after the second vaccine administration. I took two doses of Tylenol on the first day. No rash.
63 2021-01-07 head discomfort, headache 20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness... Read more
20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness. BP 151/93, 10 minutes later BP 130/83. Severe Dizziness and intense anxiety attacks commenced within 24 hours and lasted for 7-8 days. These were accompanied by sensation of pressure in brain and headache. Treatment with hydroxyzine 25mg once or twice a day reduced intensity of anxiety attacks but did nothing to help with the dizziness. Headaches were intermittent during this period. Almost all dizziness subsided by day 12 post vaccine. Headaches subsided by day 5.
63 2021-01-07 headache 24 hours after receiving the first dose of covid vaccine, I started having a really bad headache tha... Read more
24 hours after receiving the first dose of covid vaccine, I started having a really bad headache that I could not get rid of even with taking 1000mg of tylenol
63 2021-01-07 headache Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: Is taking Ibuprofen/ Advil, also took Zof... Read more
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: Is taking Ibuprofen/ Advil, also took Zofran for nausea. Body aches are 10/10, sometimes improve down to 8/10.
63 2021-01-07 headache, fever, chills Her temp got up to, she think it was to '38.7'; Muscle ache but at the injection site for sure; Neck... Read more
Her temp got up to, she think it was to '38.7'; Muscle ache but at the injection site for sure; Neck pain; Chills; headache; This is a spontaneous report from a contactable nurse (patient). This 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK4176), via an unspecified route of administration, on 02Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 63-years-old. Medical history was none. Concomitant medications were unknown. Nurse stated she got her shot yesterday in the morning on 02Jan2021. So, she had had just muscle ache but at the injection site for sure and headache, neck pain and then last night starting around 6 O'clock fever and chills. Her temp got up to, she think it was to 38.7 (not clarified further) was when she finally tried to get out of bed to take it. So, she is taking Tylenol a 1000 mg around the clock every 6 hours. The patient is feeling much better but she doesn't want to go through another night like that. Outcome was unknown. For the reporting nurse fever and chills were related to the vaccine.
63 2021-01-07 headache Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the i... Read more
Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the injection arm; Her arm was stiff feeling; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), intramuscular on 18Dec2020 15:00 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The transferring agent stated that she has a caller on the line that received the first dose of the Covid-19 vaccine on 18Dec2020. She is supposed to get the second dose tomorrow 06Jan2021. She developed a urinary tract infection over new years and was put on antibiotics. She wanted to know if she could get the second dose while on antibiotics. The transferring agent stated that the caller reported that she started feeling achy and had a headache, but did not think it was related to the shot. She stated that she had injection site pain and was sore on the injection arm. She had the shot late in the afternoon around 15:00 on 18Dec2020. She said that she was sore later on that evening at the injection site and her arm was stiff feeling the next day, but it was resolved by the day after. She said that the headache came and went. She treated it with Tylenol. She said that she did not feel real good most of the day on Saturday 19Dec2020, but by Sunday she was back to normal again. The outcome of the event Urinary tract infection was unknown while the outcome of the other events was resolved on 20Dec2020.
63 2021-01-07 headache, fever fever, muscle aches,headache
63 2021-01-07 headache headache
63 2021-01-08 fever, headache, chills Chills, body aches, headache, fever. Took OTC Tylenol for fever. Naproxen for body aches. Lasted ab... Read more
Chills, body aches, headache, fever. Took OTC Tylenol for fever. Naproxen for body aches. Lasted about 12 hours
63 2021-01-08 fever, chills, headache Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki... Read more
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. I am awaiting an appointment with my primary care physician and will know then if more treatment will be recommended. Incident Report filed at the hospital.
63 2021-01-09 fatigue, headache Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine... Read more
Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine was administered. The tachycardia resolved without medical intervention within 2 minutes. The remainder of the symptoms remained the rest of the day, along with profound fatigue and intermittent self limited tachycardia. The headache was managed with Tylenol. I slept most of the day and through the night. The following day, I had a headache, which was mild. Fatigue remained. I also noted intermittent tachycardia with mild exertion, self limited, less than 1 minute. Mild soreness at injection site.
63 2021-01-09 chills, sweating, fever, fatigue chills, fever, sweating and tired started at 5:00 pm the night after receiving the vaccine, in the m... Read more
chills, fever, sweating and tired started at 5:00 pm the night after receiving the vaccine, in the morning felt much better
63 2021-01-10 fatigue Extreme fatigue/weakness body aches, especially hips
63 2021-01-10 runny nose, throat pain, cough I had a sore throat, runny nose, and coughing. Happened four days after my vaccine.
63 2021-01-10 fever severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is ... Read more
severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is - should I get the #2 dose in light of the robust antibody response to #1. Could it be even worse?? Any information on this?
63 2021-01-10 fever, cough weakness, fever, cough
63 2021-01-11 headache, fever, runny nose After receiving second covid vaccine, injection site is red with a circle larger than 2 inches (4 by... Read more
After receiving second covid vaccine, injection site is red with a circle larger than 2 inches (4 by 6 inches). Symptoms include runny nose, headache, fever and are ongoing since vaccine. Have not visited healthcare professional yet.
63 2021-01-11 headache I felt ok right after the injection but about 2 hours later I started experiencing a pressure headac... Read more
I felt ok right after the injection but about 2 hours later I started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking I felt ok but after walk; weakness; felt very poorly; This is a spontaneous report from a contactable other health care professional. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL1284), intramuscular on 04Jan2021 11:45 at single dose at left arm for COVID-19 immunization. Medical history included hypothyroidism, psoriasis. Concomitant medications included etanercept (ENBREL), and levothyroxine. The patient felt okay right after the injection but about 2 hours later, on 04Jan2021 14:30, she started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking the patient felt okay but after walking around the house for about 20 minutes, the headache started up again and the same awful feeling of weakness so she laid down and took another 2 hours nap. When the patient woke up the second time she felt as though nothing had happened, was feeling fine. So the patient would say the side effects lasted for about 5 hours. The outcome of the events was recovered on 04Jan2021 17:00.
63 2021-01-11 malaise, fever Large Erythematous area at injection site. Tender and bruising noted Low grade fever. General not fe... Read more
Large Erythematous area at injection site. Tender and bruising noted Low grade fever. General not feeling well
63 2021-01-11 chills, headache patient developed aches, chills and headache 12 hours post vaccine. Symptoms resolved within 24-48 ... Read more
patient developed aches, chills and headache 12 hours post vaccine. Symptoms resolved within 24-48 hours
63 2021-01-12 headache, throat pain Baseline tinnitus got much louder, headaches, intermittent nausea, sore throat
63 2021-01-12 malaise, chills Chills, malaise, dizziness, diarrhea, nausea
63 2021-01-12 fatigue, sleepiness Extreme fatigue. Had to sleep. Slept 2 hour nap, 9 hour night, then two more two hour naps. (6-7 ... Read more
Extreme fatigue. Had to sleep. Slept 2 hour nap, 9 hour night, then two more two hour naps. (6-7 hours is normal sleep time for me) Groggy and dizzy during that same time when awake. Resolved within 32 hours.
63 2021-01-12 fever, chills, headache Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors ... Read more
Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors to all extremities (for about 10 mins) and chills the night after getting the vaccine. tongue numbness happens to her at baseline at times, this has subsided The tremors started after stretching her arms, they stopped shaking after about 10 mins after she laid in bed. Temp was about 100-101.2 through the night Has not taken any medications for this.
63 2021-01-12 headache Starting on 1/8 she began having headaches and weakness in her legs. On 1/9 the headache got worse, ... Read more
Starting on 1/8 she began having headaches and weakness in her legs. On 1/9 the headache got worse, she had a COVID test which was negative. On 1/11 she had vomiting for hours after taking Tylenol. On 1/13 she still has a headache, but also SOB and body aches
63 2021-01-12 body temperature increased, chills Temp 101.4 body aches chills
63 2021-01-12 headache, fatigue, body temperature increased temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both leg... Read more
temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both legs; aching all over and headache and body aches ; fatigue and extreme muscle tenderness in left arm (site of injection) Temp remained at above 100.0 even with Tylenol and headache and body aches until 9:00pm. Woke up on 1/13/2021 with only symptoms being sore arm; slight headache and muscle tightness in neck.
63 2021-01-12 body temperature increased up a lot during the night after vaccination, lots of body ache, temp 100.2 dizziness during the d... Read more
up a lot during the night after vaccination, lots of body ache, temp 100.2 dizziness during the day on 1/12
63 2021-01-13 chills, headache Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee tas... Read more
Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee taste; This is a spontaneous report from a contactable Nurse (patient). A 63-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 05Jan2021 14:30 on right arm at a single dose for COVID-19 immunization. The patient known allergy included Penicillin allergy and other medical history included Diabetes 2, Hypertension, Reynauds and obesity. There is no other vaccine in the four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications in two weeks included losaeten, metformin, hydrochlorthiazide, duloxetine hydrochloride (CYMBALTA). The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 14:30 on left arm at a single dose for COVID-19 immunization. The patient experienced chills, headache, nausea, diarrhea, muscle and joint pain, strange coffee taste on 06Jan2021 02:00 and result in doctor or other healthcare professional office/clinic visit. No treatment received for these adverse events. The patient did covid test post vaccination via Nasal Swab on 07Jan2021 and result negative. The outcome of the events was not recovered. Information on lot/batch number has been requested.
63 2021-01-13 headache, fever Developed fever and headache then later developed hives, itching, and bruising. Already taking Zyrte... Read more
Developed fever and headache then later developed hives, itching, and bruising. Already taking Zyrtec daily. Began taking famotidine daily. Required Benadryl on 1/11/21 but still has hives as of 1/11/21.
63 2021-01-13 fatigue, chills, headache, fever Fever of 100.1, chills, body aches (Lower half of body only), headache, extreme fatigue. Missed work... Read more
Fever of 100.1, chills, body aches (Lower half of body only), headache, extreme fatigue. Missed work. Started at 4 am, about 18 hrs after vaccine given. Lasted 24 hrs.
63 2021-01-13 headache Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches... Read more
Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches and restless sleep, bad dreams. Next day headache, significant fatigue and body aches. Emotional feelings like I wanted to fry ( I am not a crier). 2 Nd night restless sleep, bad dreams, headache. Next day brain fog and significant dizziness and vertigo.
63 2021-01-13 chills, fever chills; fever up to 102; diarrhea; This is a spontaneous report from a contactable other healthcare ... Read more
chills; fever up to 102; diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: ek5730, expiration date: unknown), intramuscularly on the right arm on 18Dec2020 at 16:15 at a single dose for COVID-19 immunization administered at the hospital. The patient's medical history and concomitant medications were not reported. The patient previously took codeine, for which she had known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Dec2020 at 19:00, the patient experienced chills, fever up to 102, and diarrhea. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of chills, fever up to 102, and diarrhea as she talked to her family physician. The patient recovered from all the events on an unspecified date.
63 2021-01-14 chills, fever, headache Fever, chills, headache, body aches, nausea, generalized weakness
63 2021-01-14 fever, malaise, headache malaise; headache; low grade fever; dizziness; overall body aches; This is a spontaneous report from... Read more
malaise; headache; low grade fever; dizziness; overall body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided as unable to locate or read the details), intramuscularly on 08Jan2021 at 10:30 AM on Left arm at single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided) intramuscularly on 18Dec2020 at 10:15 AM on Left arm at single dose for COVID-19 immunization at age of 63-year-old. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced malaise, headache, low grade fever, dizziness, overall body aches on 08Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the Lot/batch number has been requested.
63 2021-01-14 chills, fever mid-grade fever with a temperature of 100.4 degrees F. The temperature peaked 101.4 degrees F last n... Read more
mid-grade fever with a temperature of 100.4 degrees F. The temperature peaked 101.4 degrees F last night.; Chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration in the left arm on 28Dec2020 11:45 at a single dose for COVID-19 immunization. The patient's medical history included asthma, sulfur/sulfameds allergies, and iodine dye allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included estradiol (ESTROGEN), progesterone, colecalciferol (VITAMIN D), allergy shots, and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jan2021 18:00, the patient experienced chills and were continuing today. She was experiencing a mid-grade fever with a temperature of 100.4 degrees Fahrenheit on 04Jan2021. The temperature peaked 101.4 degrees Fahrenheit last night (07Jan2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included rapid nasal pharyngeal COVID test which showed unknown results on 07Jan2021. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
63 2021-01-14 fever, chills within 24 hours vaccination shots, I had intermittent low grade fever, constant chills, and mild VER... Read more
within 24 hours vaccination shots, I had intermittent low grade fever, constant chills, and mild VERTIGO (that was the worst). Re the Vertigo, I didn't fall but experienced it whenever moving. I was bumping into walls and was dizzy whenever I moved position (e.g. sitting to standing & vice versus). These symptoms lasted 5-7 days after they began (both shots).
63 2021-01-15 headache Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I w... Read more
Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I was taken to the Emergency Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed prednisone and Benadryl. I was diagnosed with Anaphylaxis.
63 2021-01-16 malaise 2.5 hours after receiving vaccine, I started getting dizzy and vomiting. I vomited 6 or 7 times. I w... Read more
2.5 hours after receiving vaccine, I started getting dizzy and vomiting. I vomited 6 or 7 times. I was so dizzy I couldn't open my eyes without getting sick. We called ER and explained that we thought I was having a reaction to the vaccine, and their response was they had never heard of that type of reaction. I was sick all night, called my primary Dr in the am and they told me to go to ER. We had to call ambulance to take me there because I was so sick and couldn't open my eyes without having to vomit. Room spun in circles. My arrival at ER, they did MRI, EKG, blood work. My blood pressure was very high, so they connected me to a heart monitor. I had low Magnesium due to vomiting so much. I was treated with Valium and anti-vert medication and fluids. I stayed overnight in hospital- had PT Jan 13th for DX of Vertigo. Then referred to Outpatient PT for Vertigo. Dr's felt it was a "coincident" that I got Vertigo shortly after vaccine, and strongly felt it was not related. . Today is Jan 17th, and I am still dizzy, but feeling better. I have an appointment with my primary Jan 18th and not sure if I should take the 2nd dose. That is the question.
63 2021-01-16 fever, headache, chills Low grade fever, chills, body aches, headache, nausea
63 2021-01-17 fever, chills, headache 1/6 THROUGH 1/10: SEVERE HEADACHE, NAUSEA, CHILLS (OVERWHELMING), JOINT PAIN, FEVER (100), MUSCLE AC... Read more
1/6 THROUGH 1/10: SEVERE HEADACHE, NAUSEA, CHILLS (OVERWHELMING), JOINT PAIN, FEVER (100), MUSCLE ACHES. TOOK TYLENOL.
63 2021-01-17 cough 12/22 Vaccine 12/23 ER. Admitted to hospital for 7 days. Dr stated was due to fluid. Radiology state... Read more
12/22 Vaccine 12/23 ER. Admitted to hospital for 7 days. Dr stated was due to fluid. Radiology stated no fluid present. Couldn't breath. Pulmonologist put on 2nd inhaler. Coughing a lot. Not able to walk more then 6 steps without stopping to catch breath. *Has had 2nd vaccination on 1/13/2020
63 2021-01-17 fever, fatigue Fatigue; low grade fever; reddening on her face on the nasal labial area or smile line area; a very ... Read more
Fatigue; low grade fever; reddening on her face on the nasal labial area or smile line area; a very sore left arm for a day; a very sore left arm for a day and swelled up a little; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 19Dec2020 16:15 at SINGLE DOSE for COVID-19 immunization at the hospital. It was reported that the patient was menopausal. Ongoing medical histories included gastrooesophageal reflux disease (GERD), iron deficiency (reported as iron supplementation), sinus disorder, hypersensitivity; and hair disorder, nail disorder and immune system disorder (reported as help with hair and nail and immune system). Ongoing concomitant medications included fexofenadine hydrochloride (ALLEGRA) since unknown date (reported as taking for a year) for sinus and allergies, calcium (CALCIUM) since unknown date (reported as taking for a year) for menopause, famotidine (FAMOTIDINE) since unknown date (reported as taking for a year) for GERD, cyanocobalamin (VITAMIN B12) since unknown date (reported as taking for a year) to help with hair and nail and immune system, colecalciferol (VITAMIN D 3) since unknown date (reported as taking for a year or two) for menopause and multivitamin since unknown date (taking for 5 years at least). The patient received the first dose of the Pfizer COVID 19 vaccine on 19Dec2020 at 1615PM in the left arm. She then reported of a very sore left arm for a day and it swelled up a little on that same day. She then felt some fatigue a little the next day (20Dec2020) on Sunday but it didn't prevent her from going to work. On 20Dec2020 to 21Dec2020 (Sunday to Monday), she noticed a low-grade fever for a maybe 12 hours but she couldn't find a thermometer and doesn't know her temperature. She also developed a reddening on her face on the nasal labial area or smile line area but not very pronounced on 20Dec2020 (noticed it for about 8 to 12 hours). All of her symptoms resolved by the 21Dec2020. The events does require a visit to physician office or emergency room (ER).
63 2021-01-17 fever, malaise fever 99.4; muscle and bone aches; muscle and bone aches; wasn't feeling good; This is a spontaneous... Read more
fever 99.4; muscle and bone aches; muscle and bone aches; wasn't feeling good; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: unknown), via an unspecified route of administration on 09Jan2021 15:50 at a single dose for COVID-19 immunization. Medical history included menopausal, GERD, sinus disorder, and allergies. Concomitant medications included colecalciferol (VITAMIN D 3) taking for a year or two for menopausal, cyanocobalamin (VITAMIN B12) taking for a year to help with hair, nail, and immune system, calcium taking for a year for supplementation and menopausal, famotidine taking for a year for GERD, fexofenadine hydrochloride (ALLEGRA) taking for a year for sinus and alllergies, and unspecified multivitamin taking for 5 years at least for iron supplementation. The patient received the first dose of bnt162b2 (lot number: EJ1685) on 19Dec2020 at 16:15PM in the left arm. She had a very sore left arm for a day and it swelled up a little. She felt some fatigue a little the next day on 20Dec2020 Sunday but it didn't prevent her from going to work. 20Dec2020 to 21Dec2020 (Sunday to Monday), she noticed a low grade fever for maybe 12 hours but she couldn't find a thermometer and did not know her temperature. She developed a reddening on her face, but it was not very pronounced, on the nasal labial area or smile line area. It was more pronounced on the first dose, she noticed it for about 8 to 12 hours Sunday 20Dec2020. All of her symptoms resolved by 21Dec2020. She received the second dose 9Jan2021 at 15:50PM in the left arm. She noticed nothing right away but maybe 6 hours later, her left arm was very sore. She had more of a fever which she measured at 99.4 Fahrenheit on 10Jan2021. Her normal is 97.1 to 97.5 Fahrenheit which she knew because she had to get screened at work. This time, after the second dose, she also noticed she had bone and muscle aches but was all short lived on 10Jan2021. She went to church and wasn't feeling good from about 10:00AM to about 19:00PM. She did treat the fever and muscle/bone aches with Tylenol extra strength rapid relief 500mg each. She took two by mouth once 3 hours before the vaccine and again once during the night and once yesterday 10Jan2021 afternoon for a total of three times and it did help. She also rested on Sunday 10Jan2021 afternoon, took extra fluids so by the time she had to go to work she felt normal. The vaccine was not administered at military facility. No additional vaccines were administered on same date of bnt162b2. The adverse events did not require a visit to the physician's office or ER. There were no prior vaccinations (within 4 weeks). The patient had no family medical history relevant to the adverse events. Outcome of the event wasn't feeling good was unknown and of the other events was recovered on 10Jan2021.
63 2021-01-18 headache 10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10)... Read more
10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10). BP - 172/85mmHg; Pulse - 94). 10:18am - BP - 176/93mmHg; Pulse - 104 10:20am - BP - 186/93mmHg; Pulse - 105, client reports the pain and nausea symptoms are the same. Client taken to an exam room and placed lying down on her left side, head slightly elevated. Client reported feeling a bit cold, covered with disposable gowns for warmth. Temperature taken at 10:34am - Temperature: 37 degrees Celsius. 10:43am - BP 130/60mmHg, Pulse - 92. Client reported that feelings of nausea is gone, however is still experiencing slight headache 4/10 pain scale. 10:57am - BP 124/64mmHg; Pulse - 88 10:59am - BP 174/89mmHg; Pulse - 99. Client reports that she feels a sharp pain on her abdominal area by the belly button (6/10). Also reports a mid-back pain (9/10 pain scale). 11:10am - BP 162/86mmHg; Pulse - 101 11:15am - BP 147/78mmHg; Pulse - 89. Client reports abdominal pain at 5/10, mid-back pain 8/10. 11:25am - BP 155/82mmHg; Pulse - 90. Client reports abdominal pain is aching at 5/10 pain scale, mid-back pain 7/10 pain scale.
63 2021-01-18 body temperature increased, fatigue, headache Aching, HA and temp of 101.8, fatigue beginning night of 1/15. On 1/16, was fatigued, had swelling ... Read more
Aching, HA and temp of 101.8, fatigue beginning night of 1/15. On 1/16, was fatigued, had swelling of hands and face. Now resolved.
63 2021-01-18 fever, fatigue, headache, chills Fever (100.2 degrees), fatigue, headache, joint pain, chills
63 2021-01-18 fever, fatigue, headache Fever, fatigue, joint pain, dizziness, headache
63 2021-01-18 malaise Injection was administered very high on left arm(at joint level). It felt like a nail went in, and t... Read more
Injection was administered very high on left arm(at joint level). It felt like a nail went in, and then she pushed in the medicine. Just the injection process alone made me feel ill. So I waited the 15 minutes before I left, until I felt safe to drive. At noon the meds started affecting me, which is what I expected. I've continued to experience arm pain, weakness, armpit swelling and tenderness, arm not wanting to work and posturing. This is day four and its just starting to feel like its coming back "online." Monday I reported to Colleague Health, who advised me to contact my physician, who I consulted via phone this morning. Physician requested I fill out Adverse Event form.
63 2021-01-18 fatigue fatigue; This is a spontaneous report from a contactable consumer reported a 63-years-old female pa... Read more
fatigue; This is a spontaneous report from a contactable consumer reported a 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Dec2020 at a single dose for Covid-19 immunization. Medical history included ongoing chronic fatigue and Epstein Barr. The patient's concomitant medications were not reported. The patient works in a nursing home, she received her first vaccine on 29Dec2020, she said since then has had fatigue. Inquiring if this is normal and if anyone else has reported this and asking if others have reported. She is due for second dose 19Jan2021. Outcome of the event was unknown. Information on the Lot/Batch number has been requested.
63 2021-01-18 headache, fever, chills fever 102 F; headache; chills; body aches; This is a spontaneous report from a contactable Nurse rep... Read more
fever 102 F; headache; chills; body aches; This is a spontaneous report from a contactable Nurse reported for herself. A 63-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Dec2020 14:30 and the second dose single dose (lot number=EK9231) on 09Jan2021 19:15 for COVID-19 immunization. Vaccine location=Left arm, dose number 1 and dose number 2. Facility-type-vaccine: Hospital. Medical history included asthma. The patient's concomitant medications were not reported. On 10Jan2021 at 14:00 the patient experienced headache with outcome of not recovered, fever 102 °F with outcome of not recovered, chills with outcome of not recovered and body aches with outcome of not recovered. The action taken was not applicable. Tylenol was received as therapeutic measures for fever.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-01-18 headache, fever, chills from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade f... Read more
from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade fever (99 degrees) treatment taken at 0515 am --1 dramamine, 2 tylenol 0800 am- headache, temp 98.3 0915 am- headache treatment- 1 advil pm 0815 pm- temp 99, chills treatment- tylenol 3 days post vaccine- headache, nausea (treatment advil pm, dramamine) 6 days post vaccine- headache, nausea (treatment advil pm, dramamine) 9 days post vaccine--headache, nausea (treatment advil pm, dramamine)
63 2021-01-19 fatigue, fever, chills, malaise 1/15 FELT TIRED DURING THE DAY, CHILLS AND NOT FEELING WELL. STARTED APPRX 6PM. CHILLS, FATIGUE AND ... Read more
1/15 FELT TIRED DURING THE DAY, CHILLS AND NOT FEELING WELL. STARTED APPRX 6PM. CHILLS, FATIGUE AND LOW GRADE FEVER (100.1) STARTED IN THE EVENING OF TH 15TH, CHILLS AND FEVER WERE GONE IN THE MORNING, FATIGUE AND NOT FEELING WELL LAST ALL DAY SATURDAY. WOKE UP FEELING FINE ON SUNDAY THE 17TH. TOOK A TYLENOL ON SATURDAY.
63 2021-01-19 fever, headache, chills 12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,hea... Read more
12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,headache,body aches,very sore arm 36 hrs after vaccine swollen lymph nodes under rt arm, temp 99.8
63 2021-01-19 fatigue, fever, chills Chills and fever (38.8 centigrade) starting 10 hours after injection. Also body aches, joint pain, f... Read more
Chills and fever (38.8 centigrade) starting 10 hours after injection. Also body aches, joint pain, fatigue. Lasted 36 hours
63 2021-01-19 throat pain, headache Muscle pain throughout torso; Sore throat; Head ache that comes and goes; This is a spontaneous repo... Read more
Muscle pain throughout torso; Sore throat; Head ache that comes and goes; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL3246), via an unspecified route of administration, on 06Jan2021 at 12:00 AM, at single dose, for COVID-19 immunisation. Medical history included allergy to some antibiotics. Concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced muscle pain throughout torso, sore throat and head ache that comes and goes all on 09Jan2021 at 07:00 PM with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative on 07Jan2021.
63 2021-01-19 fatigue, headache dizziness, faitgue, headache, feeling tightness in throat
63 2021-01-19 headache, fever felt warm, slight fever, headache, very sore arm. Dizzy.
63 2021-01-19 chills, malaise, fever first night had chills, and didn't feel well, got off sofa and crawled into bed. had chills. around ... Read more
first night had chills, and didn't feel well, got off sofa and crawled into bed. had chills. around 9:00 pm. took Tylenol and around 4:30Am still has chills and ran fever of 103.1 and took more Tylenol. woke up about 6:30Am and felt better. chills were gone but still didn't feel well. Called Dr. but have not heard back. currently 3:00 pm starting to feel chilled again.
63 2021-01-19 fatigue redness, itching swelling, warmth at site, muscle aches, fatigue evaluated by MD, tx with pepcid, Ty... Read more
redness, itching swelling, warmth at site, muscle aches, fatigue evaluated by MD, tx with pepcid, Tylenol, Claritin,Zyrtec began 01/19/2021 with mild relief
63 2021-01-20 fatigue, headache, chills Chills-blankets and heater. 5 hours Headache-slept, 8 + hours fatigue-slept and felt run down 2 da... Read more
Chills-blankets and heater. 5 hours Headache-slept, 8 + hours fatigue-slept and felt run down 2 days
63 2021-01-20 malaise, sneezing, runny nose, fatigue, cough Coughing/cough has worsened; Tiredness; Sinus congestion; Runny nose; Dizzy; Didn't feel well; Sneez... Read more
Coughing/cough has worsened; Tiredness; Sinus congestion; Runny nose; Dizzy; Didn't feel well; Sneezing; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 09Jan2021 (11:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at a clinic (not a military facility). Medical history included ongoing rhinosinusitis from 2019; ongoing allergy multiple; bronchitis from Mar2020; upper respiratory tract infection from Mar2020; sleep apnea; bipolar depression; and post-traumatic stress disorder (PTSD). There were no concomitant medications. On 09Jan2021 (06:00), the patient had sinus congestion and runny nose. On 09Jan2021, the patient was dizzy. On 10Jan2021, the patient was coughing, and then cough was reported to have worsened; and had tiredness. In Jan2021, the patient did not feel well; and was sneezing. The patient had used a nose rinse with an alcohol rub, and took and Epsom salt bath, and had some soup as treatment for the sinus congestion and runny nose. The patient had two COVID-19 virus tests on unspecified dates, and both were labeled as inconclusive. The outcome of the events was not recovered for 'sinus congestion', 'runny nose' and 'cough/cough has worsened'; and was unknown for 'dizzy', 'tiredness', 'did not feel well' and 'sneezing'.
63 2021-01-20 fever, chills Fever, chills, body aches, nausea/vomiting
63 2021-01-20 headache Pain at injection site, headache, chills muscle aches, joint pain, restless
63 2021-01-20 chills itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight ... Read more
itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.
63 2021-01-20 fatigue severe cramps/bunch of spasms with legs and arms; quick stools; Wake up probably about an hour, hour... Read more
severe cramps/bunch of spasms with legs and arms; quick stools; Wake up probably about an hour, hour and a half then I still feel tired I ended up going back to sleep for another 4 hours; almost like pin pricking; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included blood pressure, thyroid disorder and hormone level abnormal. Previous vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation, with no side effects. The concomitant medications was reported Levothyroxine at 5 ug 1x/day for thyroid; atenolol, chlorthalidone (ATENOLOL AND CHLORTHALIDONE) 50/ 25 for Blood pressure; estradiol (ESTRACE) at once a day For hormones. blood pressure management. Patient had second shot on Friday (08Jan2021), she was fine until about 09Jan2021 2:30 in the morning then patient woke up with severe cramps and quick stools, she had about 4 dumps throughout the day she was trying to work and then by 4:30, 5 O'clock patient was having enough drinking water and a whole lot of fluids, stools along with a lot of severe cramping, so she ended up calling in today for work which was definitely not her. Then patient went ahead and she have slept 'many parts of today' (not clarified), she slept like, wake up probably about an hour, hour and a half then she still feel tired ended up going back to sleep for another 4 hours. Patient worked only 3, 3 and a half hours a day because of her health, she had 7 or 8 round so don't normally sleep long but she was healthy. 'Problem is' (voice feeble), now that patient had gotten herself a little more relaxed patient was having a bunch of spasms with legs and arms and almost like pin pricking, so said just to call and let you know she tried but couldn't do it online." Treatment was received for events, took the Tylenol 500 (unit not probed) 1 tablet, took that at 4 O'clock.. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
63 2021-01-21 headache, chills, fatigue As I was sitting at my computer and suddenly I could barely keep my eyes open, I was so tired I coul... Read more
As I was sitting at my computer and suddenly I could barely keep my eyes open, I was so tired I couldn't lift my arms and once I closed my eyes, I could not muster the strength to open them. I felt like I was going to faint and then I got nauseated and I knew I was going to throw up. With my husband's help, I did manage to get to the bathroom (about 6 steps away). I threw up and immediately sat down in the nearest chair. I threw up a second time into a vessel after that. I then got a massive headache and chills. I could barely walk with assistance up the stairs to go to bed. I have never been more fatigued. After going to bed, I slept all night and woke the next day still fatigued, but nothing like the night before. I was able to work, even though I felt really tired. I did not have much of an appetite all day and two days later, I still feel fatigued.
63 2021-01-21 fever, headache, sleepiness, fatigue, chills Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, cou... Read more
Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, couldn?t get warm. Got worse during the night. Couldn?t go to work the next day due to body aches, arm soreness, extreme tiredness. Slept almost all day 1-19-21. Spiked low grade fever during the night. Worked 1-20-21, but extremely sleepy. Injection site got hot and red. Slept 12 hours that night. Went to work 1-21-21 feeling good, just still a little arm soreness.
63 2021-01-21 fever, chills Fever, body aches, chills, nausea
63 2021-01-21 runny nose, cough I was okay during the 30 minute observation period, and was discharged. Between 1 and 1:30 am, abou... Read more
I was okay during the 30 minute observation period, and was discharged. Between 1 and 1:30 am, about 15 hours after receiving the vaccine, I woke up from my sleep suddenly, with an acute episode of chest tightness, cough, severe running nose and lacrimation. I did not have hives or lip/throat itching or swelling. I felt a little warm in the face. I took Ventolin inhaler two puffs twice 30 minutes apart + Aller-flo nasal sprays. I began to feel a bit better and then took Benadryl 25 mgms (because of my history of Angioedema) around 2:30 am. I feel better now, which is 12 hours after onset of episode, but had to take Ventolin inhaler this morning for a bit of chest tightness. I do not have a history of asthma, but have had seasonal allergies in past years. But if this is seasonal allergy, it is very unusual, since I have never had an acute episode like this without any early milder symptoms. And I haven't needed Ventolin in a couple of years. I am now concerned about taking the second dose.
63 2021-01-21 headache Nausea, headache, body aches
63 2021-01-21 headache, fatigue hives covering entire body including soft palate, headache, body aches, stiff joints, fatigue Depo ... Read more
hives covering entire body including soft palate, headache, body aches, stiff joints, fatigue Depo medrol injection, Prednisone 20 mg/day X 4 days; Zyrtec X 12 days, Benadryl X 12 days
63 2021-01-21 fever respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous ... Read more
respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad), neuroleptic malignant syndrome (broad), anticholinergic syndrome (broad), acute central respiratory depression (broad), hypersensitivity (broad), respiratory failure (narrow), drug reaction with eosinophilia and systemic symptoms (broad), hypoglycaemia (broad), COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine, the patient experienced fever, respiratory distress, and anxiety developed requiring oxygen, morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal, while of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a
63 2021-01-22 chills Chills for 3 hours and than abnormal gait which got so bad that became unable to walk for 10 hours w... Read more
Chills for 3 hours and than abnormal gait which got so bad that became unable to walk for 10 hours without falling down. At first had to hang on to things to walk and than unable to stand or sit up- felt like I was being pushed backwards. Emesis all day
63 2021-01-22 headache, fatigue Evening of both doses I had nausea which went away overnight, (also had very strange dreams with fre... Read more
Evening of both doses I had nausea which went away overnight, (also had very strange dreams with frequent waking up which might have had nothing to do with the vaccine). Second dose nausea the first night, extreme fatigue the second day which was gone by day 3. Headache from day after vaccine until today (5 days later) with more severe headache and dizziness today, but not bad enough to make me not be able to function.
63 2021-01-23 fever, chills, fatigue, headache I am submitting this report because I did not download the app until day three post vaccination. The... Read more
I am submitting this report because I did not download the app until day three post vaccination. The app would not allow me to report my vaccine reaction retroactively to include the previous days. Twelve hours post vaccination: slight chills without fever, severe headache, nausea and fatigue Twenty four hours post vaccination: severe headache, moderate nausea and fatigue Forty eight hours post vaccination: moderate headache, mild nausea and fatigue Seventy two hours post vaccination: symptoms resolved (*Correction: I believe I may have recorded the date for vaccine #1 incorrectly on the form I previously submitted regarding a reaction to my second vaccination. When asked if I had received any previous vaccinations within the past 4 weeks, the correct date for my first Covid-19 vaccination should read 12/28/2020, 10:00 am)
63 2021-01-23 fever, headache, chills Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki... Read more
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. Incident Report filed at the hospital. MRI done on 1/20/2021-saw Doctor on 1/22/2021 who diagnosed adhesive capsulitis.
63 2021-01-23 fever, chills Pfizer-BioNTech Covid-19 Vaccine EUA First developed body aches, chills around 6 pm, 1/18/21. C... Read more
Pfizer-BioNTech Covid-19 Vaccine EUA First developed body aches, chills around 6 pm, 1/18/21. Chills continued overnight and when I took my temp in the morning, it was significant at 101.1. Fever finally broke around 7pm, 1/19/21. Felt completely normal the following morning
63 2021-01-24 fatigue Achy all over and fatigue. Better every day.
63 2021-01-24 lethargy, chills, headache, nasal congestion Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extr... Read more
Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extreme pain lasted from 0140- 0500, but continued with the skin tenderness, chills, headache and joint pain. Took Tylenol. Got up once and thought I would pass out. Started resting some around 7am. Drank plenty of fluids. Drained all day. Saturday morning headache, nasal congestion, joint pain, hard to get out of bed. Drained all day. Sunday feeling better, but lethargic. Monday back to work.
63 2021-01-24 malaise, respiratory tract congestion, fever, headache, cough Had received my first dose of vaccine on 12/18 with some adverse reactions that had gotten better. O... Read more
Had received my first dose of vaccine on 12/18 with some adverse reactions that had gotten better. On 12/31/20 begin to develop drainage, light cough, not feeling all that good. Got up next morning with deeper cough, congestion and slight headache. Went to urgent care clinic as have problem in winter with chronic cough and bronchitis so thought this was the problem. I was tested for COVID and strep of which I was positive for both. As am a healthcare worker was placed in quarantine .and given antibiotic for strep. I did not then or at any time have a sore throat. Ran slight fever a couple of days of 99.8 and was sleeping a lot but never got any worse. Returned to work on 1-11-21. Continue to have a cough at times but this is nothing I haven't experienced before. I did not receive my second dose of vaccine that was scheduled on 01/08/21 as I was still in quarantine .
63 2021-01-24 headache, fatigue, chills, malaise Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, s... Read more
Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.
63 2021-01-24 headache, fever, runny nose Nausea 2 days, headache 3 days, aches 5 days, fever one day (100.2), sniffles with clear drainage, r... Read more
Nausea 2 days, headache 3 days, aches 5 days, fever one day (100.2), sniffles with clear drainage, rash over right eye across inter canthus to lower lid, redness inner right eye, and slight rash right nose.
63 2021-01-24 fatigue body aches and fatigue. better every day
63 2021-01-24 headache lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle cap... Read more
lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle capacity; headache; terrible pain in her right elbow; joint discomfort; feeling achy in her right arm and all over; feeling achy in her right arm and all over; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), via an unspecified route of administration on 06Jan2021 14:30 at single dose for covid-19 immunisation. Medical history included hypothyroidism, cholesterol. Concomitant medication included levothyroxine, atorvastatin. Patient on the line calling about the COVID 19 Vaccine on Wednesday in her right arm. Her right arm lost muscle capacity, she cannot lift, she cannot even lift a gallon of milk in the fridge. This has improved, but she still cannot use it normally. Thursday she was feeling achy; Friday she had a headache. Later that day she had the most terrible pain in her right elbow. It was excruciating pain. The next morning pain subsided. However, she does not have her full arm strength back yet. She confirmed she is a HCP. She also added, she works at the hospital. It is like a centralized monitoring system where she watches monitors connected to the care unit and since she has background as a HCP she alerts the nurses when there is an issue. She clarified her right arm lost muscle capacity was noticed on Friday 08Jan2021. She got the vaccine on 06Jan2021 and was able to drive home and it was fine. The next day, 07Jan2021 she was achy, like flu like, with joint discomfort that she normally does not have even though she is getting older. She was feeling achy in her right arm and all over. The achiness all over resolved Thursday or Friday. She confirmed she has recovered completely. On Friday 08Jan2021 she had a headache that would just not go away. The headache was not in the front, back, or above eyes so she knows it was not sinuses. The headache lasted all day. Stated by the next morning the headache was gone. Her head is fine. She confirmed she has recovered completely. She later added, even though she is getting older and forgets things. No additional details provided. She was supposed to go to work on Friday, but she was not quite miserable, but she just could not bring herself to go into work. She called out because of the headache and the arm pain had started to kick in. The outcome of the event Muscle weakness upper limb was resolving, joint discomfort was unknown, while the outcome of the other events was resolved in Jan2021.
63 2021-01-24 throat pain, headache, fatigue right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, ... Read more
right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, also left hand swelled, with rash and itching. Next day woke up with sore throat and headache, and fatigue. went to primary care doctor was put on prednisone, symptoms lasted for 10 days.
63 2021-01-25 fatigue Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse... Read more
Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse reported for herself. This 63-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Et1685) intramuscular on 11Jan2021 13:15 at single dose for an COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included atenolol Atenolol, Losartan, Calcium, plantago ovata (METAMUCIL), bifidobacterium lactis (PROBIOTIC). Patient received the first dose of BNT162B2 intramuscular in left arm on 21Dec2020 03:30 PM. No other vaccine in four weeks. On 12Jan2021, the patient experienced Arm pain at site, Fatigue, Nausea, Body aches. No treatment received. The outcome of events was not recovered.
63 2021-01-25 nasal congestion, runny nose, sneezing Cold like symptoms such as runny nose, stuffy nose, sneezing,,,,, severe back pain. Cold symptoms... Read more
Cold like symptoms such as runny nose, stuffy nose, sneezing,,,,, severe back pain. Cold symptoms were done morning of the 26th and back pain lessened by that afternoon.
63 2021-01-25 fever, chills GI issues , fever to 99.6, achy everywhere, chills
63 2021-01-25 fever Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days... Read more
Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days; Migraine headache on day 6.; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 30Dec2020 at 11:00 A.M., at a single dose, for COVID-19 immunization. Relevant medical history included high blood pressure (BP), seasonal allergies, migraine, asthma, right sided hearing loss. The patient was taking unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 01Jan2021, at 8:00 A.M., the patient experienced soreness at injection site for 72 hours. On day 3, the patient had low grade fever 99.6. On an unspecified date in Jan2021, the patient had gastrointestinal (GI) upset for 3 days. On day 6, the patient experienced migraine headache. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
63 2021-01-25 fatigue, headache, chills headache, body ache, chills, fatigue, sore arm, Nausea
63 2021-01-25 runny nose, influenza like illness, cough lost a lot of weight, but still plump; tightness in chest; Upper chest tightness with post nasal dri... Read more
lost a lot of weight, but still plump; tightness in chest; Upper chest tightness with post nasal drip, like the flu; got Covid virus/ Covid PCR testing: positive; got Covid virus/ Covid PCR testing: positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EJ1685) via an unspecified route of administration on left arm on 24Dec2020 11:00 at single dose for COVID-19 immunisation. Medical history included ongoing asthma, ongoing allergies. She was asthmatic and believed that the virus would have affected her differently if she didn't get the vaccine. If she was to catch the virus and didn't have the vaccine she may not have come out of it. The patient's concomitant medications were not reported. The patient denied getting any other vaccines that day or 4 weeks prior. No problems with vaccines in past. Received the COVID vaccine at her workplace. The patient got COVID virus on 07Jan2021. It was also reported that the patient lost a lot of weight, but still plump, coughing, tightness in chest, upper chest tightness with post nasal drip, like the flu, body aches, all on an unspecified date. Emergency room visit needed for the events (body aches, runny nose). The patient underwent lab tests and procedures which included Covid PCR testing: negative on 04Jan2021, positive on 07Jan2021, rapid COVID testing: negative on 01Jan2021. The outcome of the event (got COVID virus) was not recovered, of other remain events was unknown. Clinical course: The patient received the first dose of BNT162B2 on 24Dec2020, and a couple weeks later she got the COVID virus (07Jan2021). Mentioned she lost a lot of weight, but still plump. Probably be in the hospital now. Still had some coughing, tightness in chest, but it's not as bad. Upper chest tightness with post nasal drip, like the flu, runny nose in throat that goes down into the lungs and when it goes down she coughs and hacks to get rid of it. Went to the doctor office on the 01Jan2021 and did a rapid test and it was negative. Then on 04Jan2021 she did another PCR Covid test and it was negative. On 07Jan2021 she had symptoms and was insistent on getting another test since having body aches, runny nose. Got the re-test and it came back positive when she went to the emergency room. Got the PCR test. The patient thought that the way they were testing is how it's spreading. Did the testing on the 04Jan2021 and they used a swab bigger than a cue tip, it was huge and couldn't get far up enough instead of the tiny ones. On the 07Jan2021 at her job, emergency room, they had the tiny ones and was able to go further up and that's when she tested positive. Mentioned using salbutamol (ALBUTEROL) nebulizer, over the counter cough syrup, prescription azelastine hydrochloride;fluticasone propionate (DYMISTA) nasal spray, and pseudoephedrine hydrochloride (SUDAFED). When has the dry cough she uses the ALBUTEROL nebulizer with the machine and vials at home and that slows down the coughing a lot and the other stuff with the lungs. Not taking any steroids. Using SUDAFED to stop the runny nose from post nasal drip from going into lungs.
63 2021-01-26 body temperature increased, chills, headache 428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated short... Read more
428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated shortness of breath was another symptom that she had from COVID and is continuing somewhat especially when I was a mask for work - but had not put it in the first report). Chills on Friday morning in the middle of night; woke up and my temp was 101.3 and I was feeling bad all day; had headache and went back to bed. Still have pain in hip/knee and joints and those pains got really bad after the vaccine - increased. Doctor vist told me to use Ibuprofen to 3 times a day for that pain. Shortness of breath continues from Covid symptoms and so does the hip/joint pain - it has decreased.
63 2021-01-26 fever, chills, fatigue, headache : 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning... Read more
: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning neck with stiffness . 2nd day Chills, headache. Joints are in pain along with other body pain, nausea. Now, fever 99.1. 3rd day is today, 01.27.21, voice is affected, fatigued body is very achy.
63 2021-01-26 throat pain, sweating, headache, cough, fatigue, fever About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking ... Read more
About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking for a tums. I didn't have any. I asked a coworker because my chest felt like I had heartburn. It was really bad. Protonic - a coworker gave it to me to see if that would help. And I took it. Diaphoretic - sweating - coworker noticed that I was sweating. I had pain in my jaw. I thought I was showing signs of a heart attack. A doctor came over and we told her what was happening with me. He recommended that I should be seen right away. Next thing I know, nurse is wheeling me down to ER in wheelchair as my chest pains weren't going away but ER told me I had to go through triage and wait. Finally got seen and I had an EKG - which was good. CDU unit - was admitted to and checked Troponin levels and did blood work. Everything came back fine. My EKG was being monitored all night. At one point I was feeling something and they gave me a dose of Nitro. It gave me a headache. There all night and then I did a stress test in the morning. And I was released that day. That was my day off so I was off all work. I went back to the work the day after. My granddaughter came to stay with me over Christmas and she started having symptoms of COVID. She wasn't feeling well. /She tested positive.Symptoms for COVID began for me on December 26th and was tested for COVID on December 27th - cough; sore throat; headache, fever, not got chills or lose my taste or smell (until after those symptoms were finished); belching - lots; diarrhea; upset; nausea. Extremely tired and muscles aches, joint pain - settled in my lower back and my hip. I still struggle with those joint pain and tiredness today. They put me off work until January 12 2021. I was scheduled to get the dose 2 at 9th but didn't get it that day because of COVID illness.
63 2021-01-26 fever, chills Fever, chills, unaware of surrounding, delirium- time frame from approximately 11:15 am to 4:30pm . ... Read more
Fever, chills, unaware of surrounding, delirium- time frame from approximately 11:15 am to 4:30pm . She was by herself, discovered after a phone call to check on her
63 2021-01-26 chills, headache Sudden onset of chills and shakes for about 6 hours, headache, stomach distress, muscle aches,
63 2021-01-26 chills, fever, fatigue shaking chills; temp of 101.4 at 2:00 pm; sudden onset extreme fatigue; This is a spontaneous report... Read more
shaking chills; temp of 101.4 at 2:00 pm; sudden onset extreme fatigue; This is a spontaneous report from a contactable Nurse reported for herself. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), Intramuscular at Left arm on 13Jan2021 10:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at clinic. Medical history included chronic cerebrospinal fluid leakage (CSF) Leak, intraductal papillary mucinous neoplasm (IPMN) pancreatic lesion, chronic thyroiditis with large nodule, mitral valve prolapse, osteoporosis, multiple breast fibroadenomas, timalleolar fracture, ankle, and prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lansoprazole, tramadol, potassium citrate, ASA and "Vi". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sudden onset extreme fatigue at 1:00 pm on 14Jan2021 followed by shaking chills and temperature of 101.4 at 2:00 pm. No treatment received for the events. Since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown.
63 2021-01-27 fatigue, fever, chills Extreme fatigue - throughout the entire day Chills began late afternoon Low Grade Fever 99.7
63 2021-01-27 fatigue Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been ... Read more
Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been experiencing extreme fatigue. On Sat. around 5:00 PM she was standing at her flat-top stove cooking dinner. A wave of very extreme fatigue came over her, so she leaned over to turn off the burner. When she did this, she passed out leaning forward with her hand on the burner and touching the frying pan. When she came to, she went to the couch and laid down - not realizing for 10 minutes that her hand and right breast were burned. The resulting injuries lead to her having to see her PCP on Monday, and then a General Surgeon on Weds 1/27/21. Injuries sustained include a second degree burn on her right breast, On the right arm, laterally above the wrist is a small superficial partially healed burn. On the dorsal aspect of the right fifth finger there is a longitudinal burn that goes from the MCP joint to almost the tip of the finger. She has limited range of motion due to discomfort and swelling. The blister encompasses the entire dorsal lateral aspect of the finger. The fourth right finger has a less extensive blistered area on the PIP joint. The burn on the fifth finger is deep second degree.
63 2021-01-27 fever fever, nausea, vomiting, severe body aches severe left arm pain, all symptoms worse that 1st dose. F... Read more
fever, nausea, vomiting, severe body aches severe left arm pain, all symptoms worse that 1st dose. Fever persisted from 1/7/21 to 1/10/21. Seen in ER 1/9/21 with T 101.9 again & workup (-) for bacterial infection /sepsis , COVID neg, flu neg.
63 2021-01-27 fever, respiratory tract congestion sick with a fever, body aches, congestion, diarrhea
63 2021-01-28 headache, sweating 8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest... Read more
8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-01-28 head discomfort Chest "fullness" going up to neck and head. BP 141/82 Pulse 83 O2 98% R 18 Assessed by APN at time... Read more
Chest "fullness" going up to neck and head. BP 141/82 Pulse 83 O2 98% R 18 Assessed by APN at time of incident. Pt declined ER. Will follow up with PCP
63 2021-01-28 fever, fatigue, chills Intermittent fever; chills; body aches; tiredness; pain and swelling in a axilla area of left arm; p... Read more
Intermittent fever; chills; body aches; tiredness; pain and swelling in a axilla area of left arm; pain and swelling in a axilla area of left arm; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration in left arm on 12Jan2021 at 07:00 at single dose for COVID-19 immunization. Medical history included hypertension and ventricular septal defect. The patient was not pregnant. Patient has no COVID-19 prior to vaccination. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]), docusate sodium (COLACE), losartan, omeprazole and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), via an unspecified route of administration in left arm on 22Dec2020 at 2PM for COVID-19 immunization. On 12Jan2021 at 11:30 PM, the patient experienced intermittent fever and chills, body aches, tiredness, and pain and swelling in the axilla area of left arm. Patient has not tested for COVID-19 post vaccination. The outcome of the events was recovering.
63 2021-01-28 fatigue, chills, headache, fever Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle ac... Read more
Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle aches and weakness, joint pain, severe head ache, nausea, extreme fatigue and slight confusion. Started about 11 hourse post injection and symptoms lasted 20 hours. Acetaminophen and increased water intake. Intermittent bedrest. Missed a day of work. Then suddenly everything cleared and I was wide awake and clear headed, just a little weak in muscles.
63 2021-01-28 fatigue, headache dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency... Read more
dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency, headache, vision changes, loss of appetite, dysphagia and fatigue
63 2021-01-28 nasal congestion, productive cough, chills, fever heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing h... Read more
heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing heaviness in chest/Shortness of breath; difficulty breathing heaviness in chest/ heaviness in chest with right flank pain; Chills; Sensitive skin; Super Thirsty; Fever 100.7/Low grade fever 99.9/ Low grade fever 99.0; Joint Pain; Congestion; Right arm injection site severe pain; This is a spontaneous report from a contactable other healthcare professional (Patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 06Jan2021 10:30 at single dose in Right arm for COVID-19 immunization. Medical history included hypertension. Concomitant medication included benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ, 10-12.5 MG Tablet), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER). The patient previously took codeine and experienced allergy. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient did not have covid-19 tested post vaccination. On 06Jan2021 20:00, the patient experienced Fever 100.7, Joint Pain, Congestion, Right arm injection site severe pain. On 07Jan2021, the patient experienced Chills, Fever 100.7, Sensitive skin, Super Thirsty. On 08Jan2021, the patient had Temperature 98.8, No Chills, Thirsty. On 09Jan2021, the patient was Some relief, no fever, no chills, no joint pain. On 10Jan2021, the patient experienced low grade fever 99.9, Pulse oximeter 89%, difficulty breathing heaviness in chest. On 11Jan2021, oxygen was 92%, Low grade fever 99.0. On 12Jan2021, vital signs stable no fever 97.7, oxygen 96%. On 13Jan2021, Vital Signs stable. On 14Jan2021, the patient experienced Shortness of breath, heaviness in chest with right flank pain, lots of phlegm, Temperature 98.0, Oximeter 96%. Coricidin HBP taken to relieve Congestion. Therapeutic measures were taken as a result of all reported events. The outcome of event chills was recovered on 08Jan2021, outcome of event Fever (event onset date: 06Jan2021 20:00) was recovered on 09Jan2021, outcome of event Low grade fever (event onset date: 10Jan2021) was recovered on 12Jan2021, outcome of event Joint Pain was recovered in Jan2021. The outcome of the other events was recovering.
63 2021-01-28 headache severe Headache, Axillary swelling and pain
63 2021-01-29 runny nose, headache, fatigue, fever Late evening after shot felt like was getting a cold, runny nose, tired. Next day had fever, high o... Read more
Late evening after shot felt like was getting a cold, runny nose, tired. Next day had fever, high of 100.0 F, joint pain, headache, fatigue. Lasted about 24 hours, improved by second day after shot with minor fatigue for another day, by 3rd day felt normal.
63 2021-01-29 fever Pt received her 2nd dose of the pfizer vaccination on 1/29/2021 and 5 hours later, developed a fever... Read more
Pt received her 2nd dose of the pfizer vaccination on 1/29/2021 and 5 hours later, developed a fever of 102F, muscle aches and had a syncopal episode.
63 2021-01-30 chills, headache, fever Chills, fever, headache. Symptoms started 10 hours after injection and lasted 36 hours
63 2021-01-31 fever, headache, chills 2:30 AM 1/30/21 chills, skin sensitive to touch, fever, extreme headaches, dizziness, nausea, redne... Read more
2:30 AM 1/30/21 chills, skin sensitive to touch, fever, extreme headaches, dizziness, nausea, redness at site of injection
63 2021-01-31 fatigue, headache, chills, fever Beginning 24 hours post vaccine I had Fever, headache, body aches, chills for 24 hours. For 36 hours... Read more
Beginning 24 hours post vaccine I had Fever, headache, body aches, chills for 24 hours. For 36 hours fatigue. All resolved at 48 hours when mild asthma began.
63 2021-01-31 chills, fever Fever up to 100 degrees, chills, body aches, lasting 3 days.
63 2021-01-31 headache Headache and Body aches
63 2021-01-31 chills Pfizer-BioNTech COVID 19 vaccine EUA- 7.5 hours after vaccine severe chills for 4 hours. Severe mus... Read more
Pfizer-BioNTech COVID 19 vaccine EUA- 7.5 hours after vaccine severe chills for 4 hours. Severe muscle aches for 22.5 hours.
63 2021-01-31 fever Starting 12 hours after the injection she had a fever of 101.5 degrees F lasting over 20 hours. She ... Read more
Starting 12 hours after the injection she had a fever of 101.5 degrees F lasting over 20 hours. She also experienced severe body aches, flank pain, bilateral groin and axillary nodal pain.
63 2021-01-31 headache, body temperature increased The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions... Read more
The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On 01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.
63 2021-02-03 chills, headache, fatigue 1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,... Read more
1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,nausea,chills 4th day - headache, chills and feeling hot, nausea,skin rash , itching, tired,aches 5th day - headache,chills and feeling hot, nausea,rash and uncontrollable itching, tired.
63 2021-02-03 chills, headache 8:20 pm - Patient received Pfizer COVID-19 dose 2 vaccine at 3:41 pm. Came in to c/o severe headache... Read more
8:20 pm - Patient received Pfizer COVID-19 dose 2 vaccine at 3:41 pm. Came in to c/o severe headache, dizzy, vomiting, and chills. BP high initial 176/81 P: 76, 97.7, O2: 99%. Patient has hx of HTN ans took medicine in the am. IMT called 8:25 pm, assessed vitals retaken (BP: 189/84; P:82 right arm; BP: 188/86, P: 82 left arm, and transported via wheelchair to Emergency Center for evaluation.
63 2021-02-03 fever, headache, fatigue, malaise Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperatu... Read more
Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperature is usually 97; Arm was extremely painful; Joint pain; Headache; Could not work today because I was not feeling good; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot), via an unspecified route of administration, on 13Jan2021 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history includes heart disorder. Concomitant medication included: Simvastatin, Atenolol, and medicine for my "heart". The patient reported that she received the first dose on 23Dec2021 and stated she had no reaction. On an unspecified date, the patient stated "I could not work today because I was not feeling good from the vaccine. I got it on the 13th I had off some work yesterday so I had a temperature aches and pains, fatigue and I had to call out last night. Today I am running still very slight fever, aches and pains - so it is improving." The first day, I was fine. I got it at the end of the day. The second day my arm was not red or anything but it was extremely painful, joint pain, headache, fatigue and my temperature was 99 (my temperature is usually 97). Today the temperature is lower and that does not hurt as much." The clinical outcome of the events malaise, aches and pain, fatigue, pyrexia, pain in arm, joint pain, and headache was unknown. No follow-up attempts are possible. No further information is expected.
63 2021-02-03 fever, headache, fatigue Body aches, fatigue, headache, feverish; lasted about 40 hours; felt like I had COVID again
63 2021-02-03 fever, headache FEVER, BODY ACHES, HEADACHE.
63 2021-02-03 headache Headache; vascular rash on toes; This is a spontaneous report from a contactable consumer (patient).... Read more
Headache; vascular rash on toes; This is a spontaneous report from a contactable consumer (patient). A 63 year-old female patient received first dose of BNT162B2 (lot number: 3246), via an unspecified route of administration on 16Jan2021 14:30 at single dose in the left arm for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia from an unknown date. The patient has no known allergies. Concomitant medication included metformin extended release. On 16Jan2021, the patient experienced headache and vascular rash on toes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any treatment for the events. The patient underwent lab tests and procedures which included PCR and nasal swab: both unknown results on 20Jan2021. The outcome of the events was not recovered.
63 2021-02-03 headache Numb feeling from head all the way to nose; Headache; This is a spontaneous report from a contactabl... Read more
Numb feeling from head all the way to nose; Headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration, injection in upper left arm, on 20Jan2021 at 10:45 at single dose for COVID-19 immunization; administered in a clinic, like the county clinic. The patient's medical history included ongoing over weight (stated she is 100 pounds over weight), ongoing slight heart disease, ongoing thyroid issue, ongoing blood pressure, and feeling like claustrophobic with the mask. The patient previously received swine flu shot in 1976 and experienced odd headache, and received flu shot two months ago (Nov2020). She mentioned that in 1976 she was in the military and had the Swine Flu Shot. The president made it mandatory they get it because they were afraid there was going to be an attack and they all had to get this vaccine. After getting this vaccine she had an odd headache. She also had a headache after getting the COVID 19 Vaccine, but it was not as bad. She had a little headache with the numbness after she got the COVID 19 Vaccine. While in the military when she got the Swine Flu shot they administered it with an air gun. She does not have any details to provide a lot/exp/NDC. They were just hurrying up to administer because afraid of possible biologic attack. She mentioned a lot of people have had bad reactions to the swine flu shot, but no additional details provided. Concomitant medication included metoprolol and ongoing lisinopril; both for blood pressure. There were no additional vaccines administered on same date of BNT162B2, and there were no prior vaccinations within 4 weeks. The patient experienced numb feeling from head all the way to nose on 20Jan2021 10:46, and headache on 20Jan2021. The patient called to report minor adverse reactions that occurred after getting the vaccine. She did not want her HCP contacted because she wants to ensure she gets the second shot. She clarified the reaction was odd. She had her face mask on when she got the shot. Normally she has the feeling like claustrophobic with the mask on which also occurred after she got the shot. After she got the vaccine, she also started to feel numb from her head all the way to her nose. It lasted 45 minutes. She started to feel this numb feeling 1 minute after getting the vaccine. She could tell something was not right. She thought at first it was the face mask, but after she took the mask off after waiting the 15 minutes under observation, she still had the numb feeling as it had not gone away yet. She could touch her face and could feel the numb feeling. The numb feeling was like getting a tooth filled, not that bad, but something like that. The outcome of the event numb feeling from head all the way to nose was recovered on 20Jan2021 at 11:31, and the outcome of the event headache was unknown. She mentioned she has some friends who have passed away from COVID and who were hospitalized from COVID. That is why she is so grateful for the vaccine and putting it out there.
63 2021-02-03 chills, headache, fever delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get... Read more
delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get warm even with multiple blankets; severe body aches; severe headache; fever of 101; nausea; thirsty; Symptoms began to abate today (almost 48 hours later) but still fet some foggy thinking; This is a spontaneous report from a contactable other health care professional (patient) and a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELIZ83), via an unspecified route of administration at arm left on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at arm left on 29Dec2020 at 9:30 at single dose for COVID-19 immunization. On Jan2021, the patient reported that 15 hours after second dose, he experienced extreme chills, so cold that it felt like burning ice cubes on his skin, he couldn't get warm even with multiple blankets, severe body aches, fever of 101 F, severe headache, delirious dreams, nausea, thirsty and feel some foggy thinking. The patient outcome of the event was recovering.
63 2021-02-03 headache, throat pain, malaise, fatigue sinus infection; she had Covid exposure; sinus symptoms, like ear fullness- sinus stuff; sinus sympt... Read more
sinus infection; she had Covid exposure; sinus symptoms, like ear fullness- sinus stuff; sinus symptoms, like ear fullness- sinus stuff; post-nasal drip; not feeling well; really bad headache; Sore throat; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date: unknown), intramuscular left deltoid on 06Jan2021 15:15 at a single dose for covid-19 immunization. Medical history included chronic sinusitis, and allergies to mold and pigweed. She was taking shots up to June but stopped. There were no concomitant medications. The patient did not have prior vaccination within the last 4 weeks. The reporter stated that she had fatigue, a sore throat, and "a really bad headache". She further reported that received her shot 2 weeks ago in a hospital and everything has been fine, however on Sunday (17Jan2021), she started having some fatigue. On Monday (18Jan2021), she started getting a slight sore throat and yesterday (19Jan2021), she has had mild, vague symptoms but she ended up with a really bad headache last night along with a sore throat. She is a school nurse and she has had possible exposure to a student that was positive for COVID. She feels like she has very vague, normal sinus-like symptoms. She added that she had Covid exposure on an unspecified date, as she is a school nurse and had contact with a Covid-positive patient. She stated that the contact with a known-positive Covid patient since receiving her first vaccine. She mentioned that she does have chronic sinusitis, so the sore throat is post-nasal drip, and a headache. However, this headache is worse than the headache she has had in the past. She hasn't had any sinus symptoms for the past 5 months, but she was thinking about getting a COVID test to rule this out. She explained that she is due for her second vaccine one week from today and wanted to know can she still get the second COVID vaccine if she was not feeling well on an unspecified date. She was trying to determine if she does have COVID. She inquired if getting the vaccine automatically turn a COVID test positive if she has already received the first COVID vaccine. The she states on Sunday, her symptoms were very vague. It's mostly just been Monday and Tuesday. Her throat right now is better. The patient stated she did V-safe and did fine with that. She further explained that she was just experiencing sinus symptoms on an unspecified date, like ear fullness- sinus stuff that she normally gets. She doesn't feel like it's a reaction to the vaccine and she doesn't think she is having adverse reactions. She has gone through 12 days without having any symptoms, she doesn't think it's a reaction. She stated she either has been exposed to COVID or she is getting a sinus infection. She just started having these symptoms. It's not abnormal for her, but this time since she is getting the second vaccine, she wanted to know can she go ahead and still get the vaccine if she is still having any residual symptoms. The patient clarified that she got a COVID test (non-rapid test) this morning (20Jan2021) but she has not yet received her results. She mentioned that she has her own regimen, so she doesn't have to take antibiotics. The events did not require an emergency room or physician office. The outcome of the events of the events was unknown.; Sender's Comments: Based on the available information and known product safety profile, the events fatigue, headache and malaise were possibly related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). All other reported events are assessed as Unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
63 2021-02-04 fatigue, headache, chills Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Jo... Read more
Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Joint pain one day after vaccine Fatigue one day after vaccine Foggy, light headed feeling one day after vaccine Headache and fatigue day 2 after vaccine
63 2021-02-05 malaise, fatigue Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hour... Read more
Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hours I began to notice itching. My back, neck, legs, arms. Begins once my zyrtec wears off around 7:30 pm I always take and antihistamine to keep my nose clear for better sleep. All nighttime meds are take at 8- 8:30 pm. Must take ativan to control anxiety and help get to sleep
63 2021-02-05 headache, fever Injection site pain started 6 hours after shot. 18 hrs after shot total body aches, fever, headache ... Read more
Injection site pain started 6 hours after shot. 18 hrs after shot total body aches, fever, headache lasting 16 hrs.
63 2021-02-05 headache its been 7 days now and am just getting sicker from then shot itching has increased and now have hem... Read more
its been 7 days now and am just getting sicker from then shot itching has increased and now have hematomas on my body. lungs fill heavy and headaches gotten more painful and i fell like my brain is not right. and diarrhea with pain in lower abdomen . I do not think i should be getting the second shot. I do not have a doctor and cant afford to go to er. I send you information of the first 5 days but do not have that report number.
63 2021-02-08 chills, fatigue, fever Experienced severe cold chills whereas my body felt like pins and needles all over including body ac... Read more
Experienced severe cold chills whereas my body felt like pins and needles all over including body aches and fatigue. Woke up with night gown damp, so I probably had a low grade fever.
63 2021-02-09 chills, fatigue, fever Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up... Read more
Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up half the night; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: F19262), via an unspecified route of administration at her arm on 23Jan2021 at 0.3 mg (as reported) single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that that she and her 94 year old mother got the COVID-19 vaccine at a drive thru, and her mother did great. After the vaccine she had muscle aches, chills, fever, and was cold. She had side effects that lasted 30 hours, starting that night. She was chilling so bad, she would like to know if they think it was safe for her to get the second dose of the vaccine, they said it was worse for the second. She said she could not hardly work she was so sick after the first dose. She stated that she was really cold, and really sick, and all day, she just could not sleep all night, she was up half the night because she was so cold and just feeling sick. She had joint pain, she had it all. She started taking Aleve on Sunday and she started to get better. The night after she got the vaccine she got her heater and was sitting beside it. She felt tired the whole next day. Her symptoms came quicker than that, she took the Aleve the next day. The outcome of events muscle aches, chills, fever, joint ache was recovered. The outcome of other events was unknown.
63 2021-02-09 throat irritation Patient is a 63 y/o female with itchiness to her back of her throat, tongue tingling and having trou... Read more
Patient is a 63 y/o female with itchiness to her back of her throat, tongue tingling and having trouble swallowing.
63 2021-02-09 headache, malaise left ear ringing; bad headache; nauseous; no energy; I don't feel well; This is a spontaneous report... Read more
left ear ringing; bad headache; nauseous; no energy; I don't feel well; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Elo142), via an unspecified route of administration into the left arm on 14Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included calcium (CALCIUM), vitamin d3 (VITAMIN D3) and monascus purpureus (RED YEAST RICE). On 14Jan2021, patient experienced bad headache, was nauseous, had no energy and was not feeling well. On 15Jan2021, patient also experienced left ear ringing. The patient received no treatment for the events reported. Outcome of events was recovering.
63 2021-02-10 nasal congestion, headache, fever Contracted Covid on 18Jan; Contracted Covid on 18Jan; Nasal congestion; Fever; Headache; Body aches;... Read more
Contracted Covid on 18Jan; Contracted Covid on 18Jan; Nasal congestion; Fever; Headache; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that a 63 years old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL0142 and Expiration Date 31Mar2021) via an unspecified route of administration on 14Jan2021 around 8:30am-8:45am (vaccine location: left upper arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history included compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergic to sulfa when she was a child, seasonal allergies, graves disease in 2014, which was been in remission for the last few years. Other medical history included high cholesterol. Family history included Her mother has Type II Diabetes; she has some unknown cancers in her family; no further information to provide. There was none other prior vaccinations (within 4 weeks). The concomitant medications were reported as ongoing atorvastatin at 40mg taken once daily for High cholesterol (Taken for a long time, at least 10 years).The day after she got the Pfizer COVID- 19 Vaccine she was around someone who had traveled who she did not realize had not quarantined and had seen relatives who were positive for COVID. Patient was contracted Covid on 18Jan2021 (possibly overnight while sleeping or early morning) and had Mild symptoms. First started with nasal congestion; then developed fever; headache; and body aches. Events has improved, she has gotten much better; just been having a fever on and off and nasal congestion but getting better every day; still just having a little bit of symptoms. She was diagnosed with COVID after that administration. She is not saying the vaccine gave her COVID. She called to ask if she should still get the second dose of Pfizer COVID-19 Vaccine as scheduled for 04Feb2021 with this diagnosis. Rapid COVID test (nasal swab) on 21Jan2021 and Positive for COVID. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
63 2021-02-17 headache This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.
63 2021-02-17 fever, chills This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EK9231, intramuscularly into the left arm on 05Jan2021 at single dose for covid-19 vaccination. Medical history included in Dec2020 around 23Dec2020 she tested positive for Covid-19. There were no concomitant medications. Patient said that because of the time of her retirement, she went to the VA and got the vaccination the first week of Jan2021. She said that with the first vaccination she said that she had chills, fever, and her arm hurt real bad. She said that her symptoms came on during the night. She mentioned she had experienced some side effects which went away after a few days. She had herself tested last 06Jan2021 (also reported as 07Jan2021, pending for clarification) for Covid-19 antibodies which turned out positive and PCR which turned out negative. The outcome of the event "Covid antibodies which turned out positive" was unknown, while outcome of other events was recovered in Jan2021.
63 2021-02-17 chills, throat pain, fever tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen fe... Read more
tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious. No follow-up attempts are possible. No further information is expected.
63 2021-02-17 chills very bad chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old f... Read more
very bad chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 29Jan2021 14:45 at a single dose for COVID-19 immunisation. Medical history included diabetes, cancer and sleep apnea. Concomitant medications were not reported (received within 2 weeks of vaccination). It was reported that 24 hours after getting the shot (30Jan2021 03:00 PM), she had a very bad chills, they lasted at least an hour. 12 hours after that, she got the chills again and 12 hours after that, the same thing. She took acetaminophen (TYLENOL) and that seems to help. Event was reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been requested.
63 2021-02-21 malaise, chills I developed chills on Friday, February 19, 2021 in the afternoon. Chills continued through Saturday,... Read more
I developed chills on Friday, February 19, 2021 in the afternoon. Chills continued through Saturday, February 20, 2021. Did not feel well on Sunday, February 22nd and today, February 22nd, I woke up with a nice dose of shingles on my face. Went to see the nurse practitioner at Dr office. Not sure if this is a coincidence or a result of the vaccine.
63 2021-02-21 fever nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after secon... Read more
nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after second immunization (approx. 18 hours post) and lasting approx. 12 hours, some residual abdominal pain and nausea for an additional day
63 2021-02-22 fever 2/9 NEXT DAY IN AM 99.7 FEVER; SORE ARM MUSCLE TO MOVE ARM. 2/10 DAY TWO 48 HRS 3-6:00PM TIGHT BU... Read more
2/9 NEXT DAY IN AM 99.7 FEVER; SORE ARM MUSCLE TO MOVE ARM. 2/10 DAY TWO 48 HRS 3-6:00PM TIGHT BURNING CENTER CHEST PAIN TOOK TYLENOL; WATER. 2/11 DAY 3 - TIGHT BURNING CHEST PAIN INTERMITTENT ALL DAY - TOOK TYLENOL; HYDRATED WITH WATER. 2/12 DAY 4 - NO DISCOMFORT; GOT COVID TEST TO RULE OUT - NEGATIVE. 2/13 DAY 5 TIGHT CHEST PAIN 1:00PM TOOK TYLENOL SUBSIDED ONE HOUR. 8:00PM BLOODY NOSE 30 MINUTES. OK THERE AFTER.
63 2021-02-22 chills Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This i... Read more
Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot: EL1284/expiration date not provided) via intramuscular route of administration, in left arm, on 19Jan2021 (at the age of 63 years old) as a single dose for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included losartan, amlodipine, metoprolol, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date not provided) on 29Dec2020 (at the age of 63 years old) as a single dose in the left arm for COVID-19 immunization. On 20Jan2021, the patient experienced nausea, chills, body aches, lightheadedness, trigeminal nerve disorder. On 22Jan2021, the patient was diagnosed with trigeminal neuralgia. The events resulted in a physician office visit and Emergency Room visit. The seriousness criteria was disabling/incapacitating. The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been not been tested for COVID-19. Treatment received for the events included steroids, anti-convulsant and pain relievers. The outcome of the events was not recovered. Follow-up (08Feb2021): New information from a contactable nurse (patient) includes: new event (trigeminal neuralgia), event details, seriousness criteria, treatment received and events outcome.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, nausea, chills, body aches, lightheadedness, trigeminal nerve disorder, Trigeminal Neuralgia and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
63 2021-02-23 fatigue Vision - brightly colored light flashes at edge of vision, left eye at 11:20 am, 10 minutes later a... Read more
Vision - brightly colored light flashes at edge of vision, left eye at 11:20 am, 10 minutes later also added blurred vision left eye. Both symptoms gone by 1:40 pm with no residual effects from the side effect afterwards. Fatigue for remainder of the day. No treatment other than rest in a chair until vision returned to normal.
63 2021-02-24 headache, fatigue, chills, body temperature increased Chills, 102°, headache, body aches, extreme fatigue and injection site pain Symptoms began within... Read more
Chills, 102°, headache, body aches, extreme fatigue and injection site pain Symptoms began within 45 minutes lasted 48 hrs , treated with Tylenol. Unable to get out of bed.
63 2021-02-24 fever, fatigue FELT LIKE I HAD COVID AGIAN . BODY PAIN ,FEVER , GI UPSET . SHORT OF BREATH ,FATIGUE LASTED FOR... Read more
FELT LIKE I HAD COVID AGIAN . BODY PAIN ,FEVER , GI UPSET . SHORT OF BREATH ,FATIGUE LASTED FOR 4 DAYS
63 2021-02-24 headache Lasting effects are increased heart rate, itching, hematomas, head pain, chest pain and heavy lungs
63 2021-02-25 throat irritation (2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST... Read more
(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST AND IT IS NOTED THAT PATIENT HAS PREVIOUS ISSUES WITH FLU SHOT WITH A HISTORY OF TORUBLE BREATHING. TEACHING IS PROVIDED WITH PATIENT REGARDING POSSIBLE SIMILAR REACTIONS WITH COVID-19 VACCINE AND THAT SHE SHOULD STAY AT LEAST 30 MINUTES AFTER VACCINATION IF SHE WISHES TO PROCEED. PATIENT CONSENT TO PROCEED WITH COVID-19 VACCINATION. VACCINE IS GIVEN AT 1000 INTO RIGHT ARM AND PATIENT IS ASKED TO STAY FOR OBSERVATION. AT 1030 PATIENT REPORTS TO THIS NURSE ITCHING AND HIVES. PATIENT IS OBSERVED TO HAVE HIVES COVERING BILATERAL ARMS AND CHEST. PATIENT DENIES BREATHING TROUBLE AT THIS TIME. EMERGENCY REACTION KIT IS BROUGHT TO PATIENT?S TABLE. AT 1032 ON CALL PROVIDER IS NOTIFIED OF REACTION AND ORDERS ARE GIVEN FOR BENADRYL 50MG IM. THIS IS GIVEN AT 1034 RN INTO GUTEAL AND PATIENT IS OBSERVED AND VS OBTAINED. AT 1040 PATIENT STATES HER THROAT FEELS ?SCRATCHY? AND ?TIGHT.? IT IS RECOMMENDED TO PATIENT SHE SHOULD BE SEEN IN THE EMERGENCY ROOM. PATIENT AGREES TO THIS IF SHE IS ABLE TO DRIVE HERSELF. PATIENT IS FOLLOWED IN HER VEHICLE TO EMERGENCY ROOM FROM OFF-SITE CLINIC (APPROX. 8 BLOCKS). ON CALL PROVIDER IS NOTIFIED AND HOSPITAL EMERGENCY ROOM IS GIVEN REPORT FROM THIS NURSE. UPON ARRIVAL TO ER PATIENT IS SEEN PER MD. PATIENT REPORTS SYMPTOMS OF CHEST PRESSURE, DYSPNEA, LIGHT HEADEDNESS, ABDOMINAL PAIN, RASH, REDNESS, WARTHM AND ITCHING. PATIENT IS GIVEN 0.4 MG SUBCU ADRENALINE AND 40 MG PREDNISONE ORALLY. PATIENT IS OBSERVED IN EMERGENCY ROOM x 1 HOUR. PATIENT REPORTS SHE IS STARTING TO FEEL BETTER. PATIENT IS DISCHARGED TO AT 1206 FROM EMERGENCY ROOM.
63 2021-02-25 fever, fatigue, malaise, chills Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in... Read more
Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb/Arm still has this sensation (like sleep, cold, numb feeling); Arm still has this sensation (like sleep, cold, numb feeling); Fever 102 degrees Fahrenheight; Feeling sick; Chills; Shakes; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date: Mar2021), intramuscularly on the left arm on 07Jan2021 (09:00) at a single dose for COVID-19 immunization at the school/student health clinic (not a military facility). Medical history included ongoing rheumatoid arthritis diagnosed about 5 years ago; ongoing high blood pressure diagnosed a couple of years ago, and ongoing Grave's disease diagnosed about 30-32 years ago. Concomitant medications included ongoing hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis; and levothyroxine sodium (SYNTHROID) for Grave's disease. On 07Jan2021, the patient had cold sensation in the arm, tingly sensation down in her arm like her arm was cold/numb; arm still had the sensation (like sleep, cold and numb feeling); had fever with body temperature of 102 degrees Fahrenheit; was feeling sick; had chills; shakes; and fatigue. The outcome of the events was not recovered for 'cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb' and 'arm still had the sensation (like sleep, cold and numb feeling)'; was recovered on 09Jan2021 for 'fever with body temperature of 102 degrees Fahrenheit', 'chills', 'shakes' and 'fatigue'; and was recovered in Jan2021 for 'feeling sick'. The patient was asking if these same symptoms should be expected after the second dose, and if it would be okay to get the second dose of vaccination.
63 2021-02-25 chills anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning s... Read more
anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on 20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.
63 2021-02-25 headache general aching joint pain, headache, spine pain not muscle pain felt like back was broken started ar... Read more
general aching joint pain, headache, spine pain not muscle pain felt like back was broken started around midnight lasted untill late evening. left thigh pain like someone was doing a vein stripping. nausea no vomiting. Felt bad for 2 days. reddness on left arm not at shot site with left arm pain for 2 days. reddness in lt arm still there 02-26-2021.Red raised area warm no drainage.
63 2021-02-25 body temperature increased, sweating got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomf... Read more
got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.
63 2021-02-26 chills Cold chills, diarrhea, vomiting, shortness of breath, muscle soreness, light headed
63 2021-02-26 malaise, influenza like illness, throat pain, headache, body temperature increased Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific.... Read more
Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific. Went to be early at 9:30 and awoke at one a.m.on February 26 with splitting headache. Could not get back to sleep well and felt terrible all that day with headache, nausea, and foggy thinking, not funcional after about 2:30 p.m. Took Ibuprofen at 3 p.m., called doctor and went to ER at Medical Center. Was seen at ER a few hours later. Slept some in waiting room. Had sore throat, the worst splitting migraine type headache ever, and was extremely foggy headed, couldn't process thoughts, eyes had difficulty focusing, nausea. My temperature was a little high for me, I am normally low and it was 99. My blood pressure is usually low and it was 105/59, pulse was 82 and respiration was 16 with 96 % Oxygen Saturation. They did tests and had an ophthalmoligist give me an exam also. They said I could go home with the same meds they were giving me in the hospital since they were working to alleviate my painful headache, 600 mg of ibuprofen, reglan and benadryl. Before I left they gave me the potassium chloride. I am continuing my medications today, two days after my vaccine.
63 2021-02-28 fatigue, fever Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction... Read more
Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction analogous to exacerbation of her autoimmune disease (LUPUS) which had been in remission (on medication) for 5 years.
63 2021-02-28 chills, headache Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chi... Read more
Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chills aches and pains and headache the latter lasted three days
63 2021-02-28 fever tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report fro... Read more
tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), via intramuscular route of administration in the left arm on 15Jan2021 10:05 at a single dose for COVID-19 immunization. Medical history included open cholecystectomy in 1990, hypertension, and sleep apnoea (CPAP). The patient's concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22 Dec2020 and experienced fever, nausea, vomiting, diarrhea, metallic taste in mouth, Loss of taste/smell, minimal soreness at the site of injection, strange sensation of tingling in her skull, chills, dry mouth, feels like she has no saliva, tongue felt a little bit too dry, extremely tired, thirst, and altered taste. The patient experienced mild left arm soreness on 15Jan2021 and fever 101.8 on 16Jan2021 23:00. Patient took ibuprofen 400mg and ondansetron (ZOFRAN) 4mg. The patient also experienced tingling sensation left skull continues as described. The patient had no cough, sore throat, stuffy or runny nose. She had no shortness of breath, no nausea vomiting or diarrhea, and no loss of taste/smell or metallic taste in mouth. The patient underwent lab tests and procedures which included body temp: 99.7 on 15Jan2021 18:00, 101.8 on 16Jan2021 11 PM, 99.5 on 16Jan20213 PM, 99.8 on 16Jan2021 10 PM, 99.5 on 17Jan2021 9:00, 99.8 on 17Jan2021 8 PM, 100 on 17Jan2021 10 PM, 99.4 on 18Jan2021 07:00, 99.7 on 19Jan2021 16:00, 98.6 on 20Jan2021 11 AM. Outcome of tingling sensation left skull was not recovered, of remaining events was unknown.
63 2021-03-02 sweating Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at... Read more
Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.
63 2021-03-03 dehydration, headache About 9 PM headache started and I had that until Saturday morning. I don' t get headaches that often... Read more
About 9 PM headache started and I had that until Saturday morning. I don' t get headaches that often so it was unusual. I took Tylenol - which helped. I was admitted to the hospital for February 8 for bronchitis. About the fourth of February is when I started getting symptoms of this. I was in the hospital from the 8-10th. Hospital. Bronchitis resolved around the 20th of February.
63 2021-03-03 fever Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in ... Read more
Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in diameter); swollen; hot to touch; other vaccine same date dose number 6; This is a spontaneous report from a contactable healthcare professional (patient). This 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL3247) via an unspecified route of administration in the left arm on 29Jan2021 at 14:15 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to shellfish and allergy to eggs, both from unknown dates and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EL0142) in the left arm on 11Jan2021; codeine from an unknown date for an unknown indication and experienced allergy; celecoxib (CELEBREX) from an unknown date for an unknown indication and experienced allergy; and alendronate sodium (FOSAMAX) from an unknown date for an unknown indication and experienced allergy. The patient reported fever, joint and muscle pain 24 hours after the vaccine and stated it lasted about 18 hours. She also reported about the injection site that it was a large red spot (about 4 inches in diameter), it was swollen and hot to touch starting about 24 hours after vaccination. She reported 3 days later it was still red, swollen and hot to touch. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of fever, joint and muscle pain were recovered on 31Jan2021. The clinical outcomes of large red spot (about 4 inches in diameter), swollen, hot to touch were not recovered. The clinical outcome of other vaccine same date dose number 6 was unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.
63 2021-03-03 chills, fever Severe body aches/chills and 101 fever for about 8 hours had to be in bed couldn?t function This occ... Read more
Severe body aches/chills and 101 fever for about 8 hours had to be in bed couldn?t function This occurred with the 2 nd shot also
63 2021-03-03 chills, fever, headache, fatigue Tiredness, headache, muscle pain, chills, fever
63 2021-03-04 headache Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as w... Read more
Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as well as my cheeks. Then my lower lip began to swell. I would consider these symptoms somewhere between mild to moderate. The symptoms began around 4:30 in the afternoon and subsided as the evening progressed. The next morning (today), my face feels basically normal again. My only symptoms now are a sore arm and a slight headache. I have experienced allergic reactions before but never from a vaccine.
63 2021-03-04 fever Began running a fever until 5 a.m. on 3/5/2021. The fever stayed at 100+ even with Tylenol. Tempe... Read more
Began running a fever until 5 a.m. on 3/5/2021. The fever stayed at 100+ even with Tylenol. Temperatures were: 101, 102, 103, 106. I literally ran the same symptoms as I had when I was ill with covid a year ago. I would have sought out help if it didn't break by the next day. I kept cold compresses on my head and back of my neck.
63 2021-03-04 fever after 6 (six) days of the 1st (first) shot, had fever of 100.2 degree by arm and whole body aches. ... Read more
after 6 (six) days of the 1st (first) shot, had fever of 100.2 degree by arm and whole body aches. the symptoms gradually and finally went away in 36 hours
63 2021-03-07 dehydration Increased heart rate; Feeling very dehydrated; This is a spontaneous report from a contactable nurse... Read more
Increased heart rate; Feeling very dehydrated; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization and lisinopril, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for hypertension. Medical history included patient was prediabetic. The patient's concomitant medications were not reported. On an unspecified date in 2021, patient was having a little bit of concern, she just had side effects that were a little scary. She have had like an increased heart rate and now, feeling very dehydrated. The action taken in response to the events for lisinopril was unknown. The outcome of the events was unknown. Information on the lot/batch number has been requested.
63 2021-03-07 fatigue Swelling in ankles/feet/calves/upper thighs, shortness of breath, fatigue. muscle soreness all over,... Read more
Swelling in ankles/feet/calves/upper thighs, shortness of breath, fatigue. muscle soreness all over, joint pain (esp. wrists & knees). Was hospitalized for 3 days 3/20 - 3/23/2021.
63 2021-03-07 fever, fatigue, headache, chills Tiredness, headache,muscle pain,chills,fever all cleared up in 24 hrs; minor dizziness on 3rd day cl... Read more
Tiredness, headache,muscle pain,chills,fever all cleared up in 24 hrs; minor dizziness on 3rd day cleared up after several hours.
63 2021-03-09 chills, sleepiness, fever, fatigue Chills; achy; low grade fever; tired; Arm sore at injection site; all the patient did was sleep.; Th... Read more
Chills; achy; low grade fever; tired; Arm sore at injection site; all the patient did was sleep.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EM9809) via an unspecified route of administration on 04Feb2021 16:00 in the left arm at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, COVID (prior vaccination). There was no other vaccine in four weeks. The patient received other medications in two weeks (unspecified). The patient has no COVID tested post vaccination. The patient experienced chills, achy, low grade fever, tired, arm sore at injection site, and all the patient did was sleep. Event onset date reported as 05Feb2021 06:00. Following day, feel much better. Body temperature showed low grade fever on 05Feb2021 06:00. No treatment received for the events. The outcome of the events was recovered in Feb2021.
63 2021-03-09 headache Thickening of tongue; itching arms,legs,face, head; headache; This is a spontaneous report from a co... Read more
Thickening of tongue; itching arms,legs,face, head; headache; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 06Feb2021 at 12:00 (at the age of 63-year-old) at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included asthma, fibromyalgia, COVID-19 and allergies, all from an unknown date and unknown if ongoing. Concomitant medication included fluticasone furoate/vilanterol trifenatate (BREO ELLIPTA), tiotropium bromide (SPIRIVA), spironolactone, simvastatin and omeprazole (PROTONIX). On 06Feb2021, the patient experienced thickening of tongue, itching (arms, legs, face, head) and headache. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered. Information on the lot/batch number has been requested.
63 2021-03-10 headache pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; S... Read more
pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown. Information on lot and batch number has been requested.
63 2021-03-14 fatigue Fatigue; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old female p... Read more
Fatigue; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 18Dec2020 at SINGLE DOSE at left deltoid for covid-19 immunisation. Medical history included hot flushes from an unknown date, MCI from an unknown date. The patient's father had medical history of diabetic-II, obesity, the patient's siblings had medical history of environmental allergies, pre-diabetic, obesity. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) from 2005 and ongoing at 150 mg daily for hot flashes, curcuma longa (TURMERIC) from 2018 and ongoing at 1 tablet twice a day for MCI. The patient experienced fatigue on an unspecified date. The outcome was unknown. The reporter considered the Pfizer product had a causal effect to the adverse event.
63 2021-03-14 fatigue, fever, malaise, headache, chills Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she wo... Read more
Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she would step down; Loss of appetite; She slept all day; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264B), intramuscular on 01Feb2021 at single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on 11Jan2021 for COVID-19 vaccination. Caller was a consumer that was calling about the Covid-19 vaccine and said that she wanted to report her symptoms after the Covid-19 vaccine. Caller reported that she experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain on, fever, feeling unwell, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day on 01Feb2021, swollen lymph nodes on her neck and dizziness on 02Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events injection site pain, chills, fever, swollen lymph nodes on her neck, dizziness, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day were recovered and other events were recovering.
63 2021-03-14 respiratory tract congestion, runny nose, nasal congestion, throat pain, productive cough, chills drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of n... Read more
drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of nasal congestion; chest congestion; productive cough; sinus infection; allergy symptoms; testing positive for Covid infection following administration for the first vaccine dose; testing positive for Covid infection following administration for the first vaccine dose; sore throat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in Deltoid Left on 19Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included Slightly elevated blood pressure from Feb2021 and ongoing, Elevated cholesterol from Feb2021 and ongoing. Concomitant medication included pravastatin (PRAVASTATIN) from Feb2021 and ongoing for Elevated cholesterol, lisinopril (LISINOPRIL) from Feb2021 and ongoing for Slightly elevated blood pressure. The patient experienced testing positive for covid infection following administration for the first vaccine dose on 04Feb2021. COVID: Initially reported onset of symptoms as 29Jan2021, but clarified onset of symptoms night of, or morning of 28Jan2021. She always had allergy symptoms like a drippy nose; she was getting ready to go get allergy testing in a few weeks; but on 28Jan2021 she noticed a real increase of sicker drainage all through the night. She thought she might had had a sinus infection. She felt cold and chills but no fever; she never had a fever; but had chills daily. She also had really bad sore throat that went away the next day; and lots of nasal congestion; chest congestion; productive cough. She still had nasal congestion and a little bit of chest congestion but chest congestion was very light in color. She had had no trouble breathing or shortness of breath; other than from her nose being stopped up. Seriousness criteria: Caller reported no emergency room visit, doctor's office visit or hospitalization related to this event. The patient underwent lab tests and procedures which included Flu test: unknown results on 03Feb2021, SARS-CoV-2 RT-PCR test: positive on 04Feb2021. The outcome of event sore throat was recovered 1 day later on unspecified date, lots of nasal congestion was not recovered, while for other events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
63 2021-03-15 influenza like illness, fever, chills Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous repo... Read more
Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on Left upper arm via an unspecified route of administration on 27Jan2021 2:30/3 PM at single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously took first dose (lot number: EJ1685, EXP: 31Mar2021) at 4:30 PM for covid-19 immunisation. Caller says she got this number from the pamphlet that was given to her when she gotten her first dose of the Pfizer COVID Vaccine. She got the second dose yesterday. Early this morning (around 2 or 3 AM this morning 28Jan2021) in the middle of the night she started having flu-like symptoms. She was calling to make sure to report them and she wanted to know if it was okay to take Tylenol. She cannot remember if the people who gave her the vaccine said if she could take Tylenol if she needs it. She had a fever this morning of 100.6. She also has chills and achiness. She volunteers at a healthcare facility, which is where she got the vaccine. She will call them about it. Got the second dose yesterday 27Jan2021. She kept waking up overnight and could not get warm. She just was unable to get warm. It was early this morning. She had went to be around 11:30 PM and felt perfectly fine. She tried to drink OJ and keeps trying to drink lots of water. She ate some protein, some cheese. She was concerned not to eat because she did not want to counter balance the nausea and it get worse. She had a tinge of nausea this morning. Outcome of the events nausea and flu-like symptoms was unknown, Outcome of the event waking up over night was recovering. Outcome of the other events was not recovered. Information on the Lot/Batch number has been requested
63 2021-03-18 chills Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous ... Read more
Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm at 63-year-old (not pregnant at the time of vaccination) on 03Mar2021 at 16:00 (lot number: EN6198, expiration date unknown) at single dose for COVID-19 immunization. Medical history included diverticulitis. No known allergies were reported. The patient was not diagnosed with COVID prior vaccination. Concomitant medications were reported as unspecified other medications in two weeks. No other vaccine in four weeks. On 04Mar2021 at 06:00 AM the patient experienced chills stomach pain joints vomit weak blood pressure (as reported). The events resulted in hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 04Mar2021. No COVID tested post vaccination. It was unknown whether treatment was received. The outcome of the events was not recovered.
63 2021-03-18 fatigue blood sugar was 25, The patient then asked for information about potential hypoglycemia; Patient fel... Read more
blood sugar was 25, The patient then asked for information about potential hypoglycemia; Patient felt tired after the dose; This is a spontaneous report from a contactable pharmacist. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Feb2021 at 13:00, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 12Feb2021, the patient felt tired after the dose and laid down to take a nap. Patients husband later checked on patient and tested her blood sugar. Husband reported that the patient's blood sugar was 25. The patient then asked for information about potential hypoglycemia post vaccination and whether she is safe to get 2nd dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of blood sugar decrease, cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-03-28 fatigue, fever Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (... Read more
Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (severe) Brain "fog" (severe) Sensation of overheating / burning Fever (few mild elevations) Loss of Appetite /Indigestion (resolving as of March 26)
63 2021-03-28 headache had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since ... Read more
had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since 18 years so now it's heavy; Headache; Acne/cramping/was very irritable/it was PMS; tremor; an itchy chest including nipples/itchy rash, not swollen but a rash on chest and nipples which were itchy; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 06Mar2021 14:45 (Batch/Lot Number: EL3302) as a single dose for COVID-19 immunization. Medical history included Parkinson's, hypothyroidism, aortic insufficiency, allergies: penicillin, tea tree oil, latex, whey. Patient is not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1998 and ongoing, carbidopa, levodopa (CARBIDOPA LEVODOPA) taken for Parkinson's disease from Feb2013; and estradiol (VIVELLE DOT) for estrogen therapy. Patient previously took prochlorperazine edisylate (Compazine) and morphine and experienced allergies for both. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has not had a period for 18 years. On 07Mar2021 12:00, patient got an itchy chest including nipples, irritability, acne and a heavy full blown period with clotting, cramping, etc. AE resulted in doctor or other healthcare professional office/clinic visit. Events were also reported as follows: patient experienced itchy rash, not swollen but a rash on chest and nipples which were itchy. Patient had Parkinson's and her symptoms got worse. She just went to her neurologist and thought that was a little strange and patient had headache. It was reported that she was irritable, it was PMS. Then patient had full blown period and patient have not had period since 18 years so now it was heavy. Patient had neurology appointment a short time ago and she was doing great and she also had her urology appointment on 23Feb2021 and everything was fine. Patient did use Vivelle-Dot which is half of a milligram, it is an estrogen therapy, but patient have never had any problems with bleeding at all, "nothing like that ever". Itching started on 06Mar2021, and then over the next couple of days, patient started having headaches, irritability, cramping, just overall Parkinson's symptoms, and tremor (medication wasn't controlling her tremor anymore). Patient has not recovered from the events.
63 2021-03-28 runny nose, fatigue runny nose since day after getting shot; nervous about second shot; worried; facial neuropathy flare... Read more
runny nose since day after getting shot; nervous about second shot; worried; facial neuropathy flare; facial neuropathy flare; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6201, expiry date not reported) via an unspecified route of administration, administered in left arm on 25Feb2021 08:30 at a single dose for COVID-19 immunisation. Medical history included facial neuropathy, sleep apnea from 2003, and Guillain-Barre syndrome from 2001. Patient said she had Guillain-Barre syndrome 20 years ago and has residual neuropathy from that. There were no concomitant medications. Patient have not had any other recent vaccinations or started any new medications. Patient called about the Pfizer COVID-19 vaccine shot, as she was supposed to call about possible side effects, to report. She said that she had her first dose of the vaccine on 25Feb2021 and hasn't had her second yet. She said that the first dose was injected in the morning, around 08:30AM. She said that there was a sticker on her vaccine card that says mRNA Pfizer-BioNTech, and (withheld), she didn't know what that means. She said actually that was abbreviation for (withheld), her vaccine provider. Her side effects included fatigue on an unspecified date in 2021, which she thinks a lot of people do have. She didn't know if this was available but she was hoping to advice about getting her second shot. She has had a runny nose since day after getting the shot, so since 26Feb2021, it hasn't stopped. She was not saying this was from the shot, it could be chronic runny nose, but it didn't stop. She said that the worst thing she was calling about was she has facial neuropathy flare in 2021, described as slight facial neuropathy which felt like it has flared since the shot. She was calling because she was nervous about second shot in 2021, since it flared with the first one a bit. She didn't want this to get worse, she can live with it currently, but she has heard people have more problems with the second dose and she didn't want to risk full blown neuropathy. She has done no treatment for the neuropathy, but for the runny nose there were a couple nights she took Benadryl and today she took Claritin, so put that she has taken sporadic over the counter stuff. No further details provided about Claritin or Benadryl. She has been experiencing continuous runny nose, flare of facial neuropathy, and fatigue. She was worried in getting the 2nd dose in 2021 and wanted to have recommendations as her doctor was reluctant in giving an advice whether she may have the 2nd dose or not. The patient reported that facial neuropathy flare as serious medically significant while the other events was non-serious adverse events. Patient was advised by the Pfizer colleague of the overall safety summary that indicated throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell's palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19. The outcome of the events facial neuropathy flare, fatigue, nervous and worried was unknown. The event runny nose was not recovered.
63 2021-03-30 malaise, headache really bad headache, excruciating headache; nauseous, nausea/queasy; blurred vision; holes in her vi... Read more
really bad headache, excruciating headache; nauseous, nausea/queasy; blurred vision; holes in her vision; not right; like an allergic reaction; She had soreness in the arm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 05Mar2021 16:32 (Lot Number: EN6198; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included allergies to Sulfa drugs, Penicillin, and believes she has allergies to Ploymers (She cannot wear polyester and she has to wear 100% cotton). The patient's concomitant medications were not reported. The patient (at the age of 62-year-old) previously received the second dose of Shingles Vaccine in Jan2021 for immunization. The patient experienced really bad headache, excruciating headache on 09Mar2021 21:00, nauseous, nausea/queasy on 09Mar2021, she had soreness in the arm on 05Mar2021, blurred vision on 09Mar2021, holes in her vision on 09Mar2021, not right on 09Mar2021, like an allergic reaction on 09Mar2021. She developed a "really bad headache" around 9pm on Tuesday 09Mar2021, that caused holes in her vision and pain "straight across my forehead". She did treat with Tylenol and was able to finally sleep around 5am. She states that the headache has persisted, and she's felt "nauseous, queasy, and not right" since the headache started. She is hesitant to get the second dose. She was experiencing headache following. She mentioned she is allergic to sulfa drugs, penicillin, and polymers, and thought maybe the headache was a result of an allergy to the vaccine? Ingredients don't appear to have any of her reported allergens. She had soreness in the arm the first 48 hours, which was to be expected and no big deal for her. However, starting on Tuesday, she had an excruciating headache. She normally does not typically get headaches. She believes in vaccinations and as a teacher the minute she could sign up to get one she did. Now she is terrified to get the second one. When this excruciating headache began she woke her husband up to tell what happened. She thought she was going to die, that is how bad it was and she wanted him to be aware and prepared if anything should happen. The excruciating headache started at 9PM. It was excruciating all night. The headache made her queasy because she hurt so bad. It continued into Wednesday. Today and today the pain is duller in her head, much duller than it was. However, she still feels queasy/nauseous. The headache also started with blurred vision. The blurred vision has gone away. It was like there were holes in the TV. She was thinking it was interesting and did not think much of it at first. She thought one of her contacts had a hole in it, but she did not even have any on. The blurred vision lasted 24 hours. The soreness in arm lasted until Sunday or Monday. She confirmed the pain in arm is gone and was gone by Monday. She initially could not wait to get her shot. Now she is terrified to get the second one. She took Tylenol in the middle of the night on Tuesday and Wednesday for the headache. Has allergies to Sulfa drugs, Penicillin, and believes she has allergies to Ploymers. She cannot wear polyester. She has to wear 100% cotton. She is questioning if the vaccine has polymers in it. From what she heard it does and is wondering if this caused her to have like an allergic reaction. The outcome of the event vaccination site pain was recovered in Mar2021, the events Nauseous and headache was not recovered, other events was unknown.
63 2021-03-31 fever, influenza like illness passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pai... Read more
passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pain; temperature of 99.6; flu-like symptoms; This is a spontaneous report from a contactable Other Health Professional (patient). A 63-year-old non-pregnant female patient received bnt162b2 (Pfizer Brand COVID 19), dose 2 intramuscular, administered in left arm on 26Feb2021 12:00 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination. The patient has no known allergies. Concomitant medication included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer Brand COVID 19), dose 1 intramuscular, administered in left arm on 05Feb2021 11:30 AM, (Lot Number: EM9810) for COVID-19 immunisation. There was no other vaccine in four weeks. On 27Feb2021 07:45, the patient passed out, unfortunately hit head, felt light headed and slightly nauseous. It was also reported that patient had intense right knee pain, a temperature of 99.6 and flu-like symptoms. The events were also described as follows: 18hrs after the injection, I had intense right knee pain that lasted for 24hrs. Also in that same time period, I felt a huge rush of energy come over me and passed out. Unfortunately hit my head. I had a temperature of 99.6 and flu-like symptoms that lasted 24hrs. For 4 days I felt light headed and slightly nauseous but that could have been due to hitting my head. Called 911, EMT evaluation and the patient received treatment for events. Outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events and other events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
63 2021-04-01 headache onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue,... Read more
onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had Bell palsy; Awakened with brief episode (10 min) severe abdominal pain; Severe muscle aches; Head pain; Neck pain; Developed sore on left side of tongue; Neck/mastoid pain; Swollen gland lasted a few days; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6200, Expiry Date: unknown) via an unspecified route of administration in left arm on 24Feb2021 13:30 at single dose for COVID-19 immunisation. Patient had historical vaccine at 63-year-old BNT162B2, lot number: EL9262 at left arm on 03Feb2021 13:30 at SINGLE DOSE for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's medical history included penicillin and neomycin allergy. Patient's concomitant medications included ergocalciferol (VIT D), rosuvastatin calcium (CRETOR) (medications the patient received within 2 weeks of vaccination). On 25Feb2021, the patient experienced onset of symptoms of left-sided bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had bell palsy, awakened with brief episode (10 min) severe abdominal pain, severe muscle aches, head pain, neck pain, developed sore on left side of tongue, neck/mastoid pain, swollen gland lasted a few days. Event was reported as on 25Feb, patient awakened with brief episode (10 min) severe abdominal pain. Later, severe muscle aches, head and neck pain, lasted until following Wednesday (03Mar). Patient developed sore on left side of tongue, neck/mastoid pain, swollen gland; lasted a few days, then noted onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). By friday 12Mar she knew she had Bell palsy. Medrol dosepak, OTC pain meds was received as treatment for adverse events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-04-01 fatigue, runny nose, influenza like illness, dehydration, sleepiness rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso... Read more
rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.
63 2021-04-06 chills, headache, fatigue Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination); Severe headache; Mus... Read more
Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination); Severe headache; Muscle aches; Chills; Fatigue; This is a spontaneous report received from a contactable pharmacist reporting for herself. A 63-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534), via an unspecified route of administration on 23Mar2021 10:00 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included calcium carbonate (CALTRATE), ascorbic acid, retinol, tocopherol (OCUVITE). Historical Vaccine included first dose of BNT162B2 (Lot number EN6203) on 23Mar2021 at 10:00 AM for COVID-19 immunization. The patient experienced Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination), Severe headache, Muscle aches, Chills and Fatigue on 23Mar2021 20:00. Treatment received for event headache included Tylenol 1grm at 9:30 am 3/24. The outcome of the events were resolving. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported event parosmia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-04-07 fatigue Only initial side effect following both injections was moderately sore arm and fatigue. Following 2... Read more
Only initial side effect following both injections was moderately sore arm and fatigue. Following 2nd dose I experienced 1 episode of severe vertigo while just sitting doing nothing. Dizziness cleared completely in about 4 minutes. Then on March 13th, was at work, sitting at desk and same thing happened again. After the dizziness cleared I got up and went to see a patient. I work in a rehab unit of a hospital. Got pt approx 50 feet down the hallway when dizziness started coming back. Handed patient over to other staff. I took my blood pressure and checked my blood sugar. Both WNL . Dizziness never got better. Went to ER. They had no clue of cause. All labs were normal. Saw Physical therapist who performed Eply maneuver as well as a ENT. Both got same result. Negative for BPPV. MD gave me Antivert. Didn't work. Are waiting to be seen in May 2021 for NVT test and another with Neurologist. In the meantime the dizziness has remained constant rendering me unable to return to work.
63 2021-04-09 sweating, chills, fever Chills, fever-diminished sweats-resolved 4/5/2021 migrating erythema, tenderness under erythema, ... Read more
Chills, fever-diminished sweats-resolved 4/5/2021 migrating erythema, tenderness under erythema, anorexia, bladder irritation-persistent
63 2021-04-09 influenza like illness, pneumonia, fever pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circ... Read more
pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circle around it and it's hard; she had a little bit of pneumonia; got a fever; felt like she couldn't go to the bathroom, cramps; had trouble breathing; the site was red; swelling/her arm is swelling; it does hurt her, right in that area where the shot was given; arm was sore and achy/her arm started aching; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6208, expiration date unknown), via an unspecified route of administration, administered in left arm on 22Mar2021 at the age of 63 years old at a single dose for COVID-19 immunisation. Medical history included ongoing pre diabetic, ongoing high blood pressure, ongoing non-alcoholic liver disease, edema, to help her breathe, pneumonia, COVID in 2021, respiratory problems, asthma, little bit of obesity, swelling in her legs, varicose veins. Concomitant medications included benzonatate at 100 mg to help her breathe, azithromycin (six pills of that, 200mg, two one day and one pill a day until gone) for pneumonia. Patient had her second dose scheduled on 12Apr2021. She explained after the shot, her "arm was sore and achy" she said she also had "pain". She added she experienced "flu-like symptoms". She specified these adverse reactions are all gone now but her arm is still "a little sore" and she has one area with a "big circle around it and it's hard". She said it could be "swelling". She asked if her reaction was reported as side effects to the vaccine. She expressed being in a rush and is expecting her daughter soon and asked us to be quick. She said she will also consult with her HCP this afternoon. Patient stated she had the first shot on Monday 22Mar2021 and today and last night the site was red, but today in that area she has gotten a big circle around it and its hard. Patient stated she's had it before with shots and just wanted to make, sometimes she has had to be put on medicine for it, wanted to be sure its healing because it does hurt her, right in that area where the shot was given. She also stated that after she has her second shot on 12Apr2021, she would like to talk to somebody and she would like to be able to have people in her home. She was reporting she had COVID three weeks ago, would she be ok after the 2nd shot to go out? She stated her daughter thinks she needs to wait until the end of April. She verified she did receive the Pfizer BioNtech Covid 19 vaccine. Swelling: Patient stated her arm is swelling. Also stated she always gets that and today there's a circle there and it is red and hard. Also stated occurred after the shot. Patient reported that the shot hurt like heck and she couldn't really tell, she has big arms, she knows it was swollen. Reported she took over the counter medicines, last night she noticed it was a circle and it was hard there. Stated area is not swelling anymore, now just one hard red circle. Red and a hard circle: She also reporting her entire arm ached after the shot, she stated she knows her entire muscle was aching. Stated it was swollen quite a bit but now its just red and a hard circle, and it's ongoing. Arm swelling outcome: Patient reporting yesterday afternoon, she was feeling better, except that one spot. She stated it does hurt when she bends it because she had that one little area that's swollen. Also stated the swelling started later that afternoon after the shot. Reported she went for a walk with her daughter and her arm started aching. It felt like she couldn't go to the bathroom, cramps. It felt like she had a little bit of the flu, and it was from the shot but it only lasted a few days. Stated that part went fast, got a fever, other than that, just the one area on her arm. Stated she doesn't even feel sick from the shot or anything. Stated she had Diarrhea: Stated she had diarrhea in the beginning after the shot then had trouble going to the bathroom. Stated she thinks its because she has IBS and that's how her body is. She doesn't know if that's from the shot or not because that's how her body always is. Pfizer BioNtech Covid 19 Vaccine: Patient stated she doesn't want COVID again. She has respiratory problems anyway, she has asthma and a little bit of obesity. She states she was in fear of herself. She doesn't do well with hospitals and being put under with that medicine. Also stated patient knew COVID causes a lot of people having trouble breathing and she doesn't want to end up on a breathing tube where its breathing for her and she never sees her family again. Caller states it kind of scared her. Patient stated her niece and nephew, whos got it worse. She stated she went to the hospital and haven't been back. She stated she was hospitalized about 2 weeks ago, and that's when she was diagnosed with COVID, before she got the first COVID shot. About the medical history, non-alcoholic liver disease: Stated diagnosed about eight years ago, she would say the same time, about 7 to 8 years ago because she had a virus and when she went in the hospital, the virus had attacked her right kidney and liver. She stated with non-alcoholic liver disease, she is overweight, and that causes her to have issues with her liver. The last few times her liver has been okay. Pre-Diabetic: They have been watching that for a while. Stated she gets edema, swelling in her legs, well, all the time. She has had this the last two years because she is pre-diabetic and a lot of overweight people have that. She also has varicose veins so that doesn't help. Stated that was given those to help break up, because she had pneumonia when she got the COVID and she had a little bit of pneumonia and had trouble breathing. The patient was recovering from arm was sore and achy/her arm started aching, swelling/her arm is swelling and for other events it was recovering.
63 2021-04-09 malaise, fatigue, sweating sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weak... Read more
sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weakness; lower abdomen hurt; tired; vomiting; diarrhea; sweaty; little bit of rectal bleeding after diarrhea; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in Left upper arm on 24Mar2021 (Batch/Lot number was not reported; Time the Vaccination Was Given was around 15:30) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid, renal disorder from an unknown date and unknown if ongoing , diabetes from an unknown date and unknown if ongoing, blood pressure measurement from an unknown date and unknown if ongoing, vaginal disorder from an unknown date and unknown if ongoing, colitis from an unknown date and unknown if ongoing. Reported following prior vaccinations was stated she had a sore arm sometimes with the flu shot and felt kind of sick but not always. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid from an unspecified start date and ongoing (reported she started taking this decades ago); metformin (METFORMIN) taken for diabetes from an unspecified start date and ongoing ((reported she started taking this decades ago); lisinopril (LISINOPRIL) to protect kidneys with diabetes and for blood pressure, started years ago and took a small dose, stated her blood pressure was usually fine; estradiol (ESTRACE) taken for when the vaginal tissues get disintegrated from an unspecified start date and ongoing (stated she started this a very long time ago). The patient experienced little bit of rectal bleeding after diarrhea on 25Mar2021 with outcome of unknown, sick on an unspecified date with outcome of unknown, tired on 25Mar2021 with outcome of not recovered, vomiting on 25Mar2021 with outcome of unknown, diarrhea on 25Mar2021 with outcome of unknown, sweaty on 25Mar2021 with outcome of unknown, exhausted/wiped out on an unspecified date with outcome of unknown, stomach kind of hurts on 25Mar2021 with outcome of unknown, started to feel lousy on 25Mar2021 with outcome of unknown, tiny bit of dizziness on 25Mar2021 with outcome of not recovered, weakness on 25Mar2021 with outcome of unknown, lower abdomen hurt on 25Mar2021 with outcome of unknown. The event little bit of rectal bleeding after diarrhea considered serious as medically significant. The AEs not require a visit to Emergency Room or Physician Office. Received the first dose of the Pfizer Covid 19 vaccine Wednesday afternoon, yesterday, patient felt okay, but was off, got really sick in the middle of the night. during the day , tired, expected that, but at night vomiting, diarrhea and weak, sweaty, kind of bad. it stopped today she was just exhausted and her stomach kind of hurts. She was better than last night, today she was just more worn out by this, she took a Imodium. She had the vaccine Thursday afternoon and yesterday she felt lousy, nothing severe and last night she was very sick. Stated she was still trying to get better today. Stated she called and left a message with the FDA/CDC vaccine adverse event reporting system a little while ago. Caller clarifies she got the vaccine on Wednesday 24Mar2021 and that she started to feel a little lousy 25Mar2021, more like the symptoms that are described, she was tired and had a tiny bit of dizziness that came and went, it was mostly tired. Stated in the middle of the day she laid down for an hour and that was around lunch time. Stated the dizziness was off and on like when she was driving and just here and there. Stated the tired was still persisting. She stated she did not have NDC, lot, expiry date or dose to provide. Stated she see EUA on the sheet but not much else. Stated it was the 1st dose. Stated she forgot to tell about last night. Stated she woke up around midnight very sick with vomiting and had diarrhea and was sweaty. Stated her stomach hurt and her lower abdomen hurt. Stated she was not sure if these are from the vaccine or a coincidence. Stated she had stopped throwing up, just did that a few times. Stated the diarrhea stopped after a little while. Stated she still has abdominal pain today and weakness was with the diarrhea and she would lay down in bed. Stated she was still a little weak, that she was more wiped out and tired. Caller stated she was bleeding a little bit after the diarrhea and it scared her because a couple years ago she had colitis and it scared her, that she called a relative who is a retired nurse and she thought it was from the diarrhea. Caller clarified she contacted her relative about this current event with the bleeding. Caller provided that she took Imodium this morning and has been sipping on water and had a little breakfast, she thought she may be a little dehydrated. Patient stated her symptoms were pretty bad last night, it was acute. Patient clarified that it was rectal bleeding and it was just a little this morning. Stated it happened last night and again this morning. Stated she was not sure if it was still occurring and hopes it stopped as it it's scary. Stated today she was just resting and trying to get better. Patient said that if it gets worse she will call her doctor and that she had called the hospital last night and they didn't have anything to say. Stated that if it was from the vaccine she was hoping that it's very temporary and went away and be gone if it was from the vaccine. Patient was asking if there was information about the chance that this was related to the vaccine, stated they were not listed as possible side effects. Stated she had people from the hospital and relatives she has talked to that say it may be. Information on the lot/batch number has been requested
63 2021-04-13 fatigue Initial mild fatigue day 2 & 3 followed by abdominal pain day 3. Accute Appendicitis, followed by s... Read more
Initial mild fatigue day 2 & 3 followed by abdominal pain day 3. Accute Appendicitis, followed by surgery to remove appendix
63 2021-04-13 headache On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 ... Read more
On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 strokes. I woke up with a throbbing headache and then had difficultly remembering simple things like using the remote control for TV. My vision was also somewhat blurry. I then went to drive and my focus was off making driving difficult so I then went to the emergency room
63 2021-04-14 chills, fatigue, fever Chills and fever (~101.0F) at initial onset which lasted approximately 8 hours. Fatigue which laste... Read more
Chills and fever (~101.0F) at initial onset which lasted approximately 8 hours. Fatigue which lasted ~24 hours. Nausea which lasted ~8 hours. All resolved 48 hours after injection.
63 2021-04-15 throat pain, fatigue Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine sit... Read more
Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine site which is becoming bigger. Also, have a canker side in my throat-I send to get them as a child, in my throat. Also, broke my knee cap 2 years ago and it had become painful
63 2021-04-17 cough has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart ra... Read more
has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart rates; She'll have a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night.; When probing for specific event information she reports it's kind of like she coughs a little more and she is a little more short of breath and it's happening more often; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 63 years, via an unspecified route of administration on 27Mar2021 04:06 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history included asthma, hysterectomy, dark chocolate or red dye (she starts coughing and has an allergic reaction and shortness of breath), bursitis (in her right). The patient's concomitant medications were not reported. The patient previously took penicillin, experienced allergy and had really ad hives (several years ago) she was given a cream to put on. She had to get another medication and she doesn't remember the name. That medication made her dizzy and she couldn't even get out of bed so they had to half the dosage. When she had her hysterectomy she learned she couldn't take any types of "cillins" medications. The patient had been watching her heart rate with a device and since getting the Covid 19 vaccine she's noticed her heartrate was always higher than it normally is. Her heartrate was going crazy, the device was not recording right. She reports that for the last 2 days the device has been telling her she has possible atrial fibrillation. This is worrying her. She doesn't feel anything different. She was usually hyper. Her resting heartrate was higher. Normally her resting heartrate was in the 80s (beats per minute) Now it's going up to the 90s (beats per minute) then her heartrate drops to 40 something (beats per minute) Then the device said her heartrate was 118 and 107 and she's not even doing anything. She hasn't even worked out yet. She doesn't like to take medicine. Medications don't work out with her. She had a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night. It was reported that she feels fine. She has no other symptoms. She's been reporting online. Clarified she's reporting online through the V check through the CDC. She's been trying to get the Covid 19 vaccine forever. She did research on all the Covid vaccines and she felt more confident with the Pfizer Covid 19 vaccine. Her daughter was against the Covid 19 vaccine. Her daughter thinks the vaccine was just going to kill her. She reports she was healthy and she works out 6 days a week. She recently tried to get a CT scan for her heart. Her husband's cardiologist recommended her husband have a CT scan of his heart and she decided she needed a CT scan too. She's also watching her heartrate on her watch. Her husband's heartrate is completely normal and stable on the device so she knows the device isn't messed up. It was also reported that the device will tell her she has too much muscle movement and she's standing completely still. Then she'll get the device to record her heart rhythm and it goes sporadic. The device tells her 90 beats per minute at resting then over 100 beats per minute. Her heartrate on the device was going up and down a lot. When she's been watching the device record her heart, it looks like it's going crazy. Her heartrate goes way up and way down like in the 40s (beats per minute) She noticed when her heartrate is in the 40s (beats per minute) and she's never had her heartrate go down that far, it's really really weird. She thinks maybe she'll get back to normal. She keeps watching hear heartrate. She reports she noticed her heartrate right away on Saturday evening after she received the Covid 19 vaccine. Her heartrate was higher than normal for resting, it was in the 90s (beats per minute). Her resting heartrate is usually in the 60-80s (beats per minute) and it was the in 90s. Now the device says possible atrial fibrillation. It was further reported that she received the Covid 19 vaccine in her left arm because she has bursitis in her right. If she hit her arm the second day after the Covid 19 vaccine, her arm would hurt. Her arm felt better the next day. She clarifies, on Sunday, 28Mar2021, she noticed her arm felt like a bruise and that was it. Then the next day on Monday, 29Mar2021, the feeling was gone. She didn't have any redness. The outcome of the events her arm felt like a bruise and arm would get hurt was recovered on 29Mar2021, irregular heart rates, dyspnea, cough was not recovered and unknown outcome for has possible atrial fibrillation. Information on the lot/batch number has been requested.
63 2021-04-18 headache, fever Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third... Read more
Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; This is a spontaneous report from a non-contactable consumer (Patient). A 63-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), dose 1st via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:00 as single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On 01Apr2021 11:15, the patient experienced Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack. The patient had other medications in two weeks of vaccination. Patient did not took any treatment for adverse event. Patient did not had covid prior vaccination and not tested for covid post vaccination. She did not have any Known allergies and had other medical history. No follow up needed. No further information is excepted.
63 2021-04-18 headache, head discomfort intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up... Read more
intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up; rush of pressure to back of head and the lower part of head; Headache; dizzy/Dizziness/light headed; out of body experience like floating; my arm started to really hurt/Sore Arm; sore to touch; cloudy and pressure in her ears/Ear Pressure; vertigo issues; vestibular migraines; patient can't walk; tunnel vision; eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Left Arm on 01Apr2021 about 13:30-14:00 pm (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hashimoto's disease, Diagnosed 13 Years ago, patient was allergic to penicillin and Avalox (anaphylactic and I am sensitive to medications). Don't know if this happened when she got Hashimoto's, Thyroid, ongoing Vestibular Issues Started 5 years ago. States one doctor thinks it is her bad neck. States when she got old things shifted and changed. One ENT said she has neuritis, where something hit her ear nerve in right ear. States hence that was what the acyclovir was for, when she feels an earache coming on, she takes acyclovir. No previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). AEs following prior vaccinations: None; reported she hadn't had any flu vaccines in years because of the ingredients. States because of her Hashimotos because of everything with her health it was not conducive. Last one was 2014. Concomitant medications included guaifenesin (MUCINEX) taken for hypersensitivity from an unspecified start date and ongoing; fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine sodium (LEVOXYL) taken for thyroid disorder from an unspecified start date and ongoing; azelastine hydrochloride (AZELASTINE HYDROCHLORIDE) taken for hypersensitivity from an unspecified start date and ongoing; aciclovir (ACYCLOVIR ACTAVIS) taken for ear pain from Mar2021 to an unspecified stop date; naltrexone (NALTREXONE) taken for autoimmune thyroiditis from an unspecified start date and ongoing; alprazolam (XANAX) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for an unspecified indication from an unspecified start date and ongoing; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; curcumin (TURMERIC MERIVA) taken for an unspecified indication from an unspecified start date and ongoing; 7-keto-dehydroepiandrosterone (7 KETO DHEA) taken for an unspecified indication, start and stop date were not reported; ferritin (FERRITIN) taken for an unspecified indication from an unspecified start date and ongoing; boric acid, zinc sulfate (OPTIZINC) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; lactobacillus reuteri (PROBIOTICA) taken for an unspecified indication from an unspecified start date and ongoing; calcium saccharate (CALCIUM D GLUCARATE) taken for an unspecified indication from an unspecified start date and ongoing; berberine hydrochloride, coptis chinensis, glycyrrhiza uralensis, mahonia aquifolium, phellodendron chinense, rheum officinale, scutellaria baicalensis, zingiber officinale (CANDIBACTIN BR) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication from an unspecified start date and ongoing; alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) taken for an unspecified indication from an unspecified start date and ongoing; pancreatin enzymatic hydrolysate (PANCREATIN ENZYMATIC HYDROLYSATE) taken for an unspecified indication from an unspecified start date and ongoing; levoglutamide (L GLUTAMINE) taken for an unspecified indication from an unspecified start date and ongoing; betaine hcl (BETAINE HCL) taken for an unspecified indication, start and stop date were not reported, Bio Identical Hormone Cream taken for an unspecified indication, start and stop date were not reported. On 01APR2021, she could feel rush of pressure to back of head, tunnel vision, cloudy and pressure in her ears and was dizzy. Hx of Hashimoto's - autoimmune disorder, vestibular issue, concerns with getting the second one (dose). Read about adverse reactions and dizziness was on the list of severe reactions. The instant, within a minute, patient could feel this happening to her, she instantly could feel she becoming dizzy, light headed, out of body experience like floating. (didn't mention this in report) felt like walking on air. While sitting and chit chatting with other people to distract myself. Patient didn't have any anxiety. She will admit she was reluctant to get the vaccine because of my health problems. She was more concerned, she instantly got a headache with the pressure, when she was leaving, she felt her eyes feel weird, almost like an allergy issue, burning, not quite burning either. Kind of like a burning, not quite like a burning, felt like when you walk into the wind that has lots of pollen, that feeling. She didn't walk out side, she was inside when this happened, the pressure was already starting, no headache in front of head, it was in back of my skull, at top of her neck and pressure within the ears and ache and pressure on back of her head. Not dizzy, not like when you are in the hospital and they give she something and patient can't walk, or where you tried to stand and you couldn't , it was more like light headed, like walking on air like. It lasted all yesterday. As the night progressed by 10PM or 11PM her arm started to really hurt, patient took Tylenol and went to bed, took Xanax as she did and slept, woke up fine. This morning it felt like she wanted to have a headache but haven't had it since. It's almost like patient had intracranial pressure, because she had these conditions, so she read a lot. Investigation Assessment was No. States she is calling to report a potentially strange side effect. She states as soon as she got the injection, approximately within one-two minutes, she could feel a rush to the back of her head and the lower part of her head which then made her feel like she had somewhat of her vision clouded, like a tunnel vision. Clarifies her vision was clouded on the sides but she could see forward. Caller states that she was not dizzy like falling over and she does have vestibular migraines and vertigo issues, but she had that feeling of dizziness and when she got up and walked, it felt like she was walking on a cloud. Clarifies she felt a heavy pressure in the back of her head. States as soon as the injection was over, she could feel it. States she is concerned regarding the second dose because of her autoimmune and vestibular conditions. She states is caused immediate pressure in her ears. States that could've affected her and put her into a migraine, she doesn't know. States a friend said jeez you should report that and she read more on the list of side effects and saw something about an allergic reaction and dizziness, and she did have some sort of adverse reaction. States she doesn't know and it is concerning to her. States she is doing fine today, other than a little headache that comes and comes. States it was bizarre with the clouded, not cloudy, but tunnel vision. States she does not want to release any medical records; she declines for now to provide. She states CVS administered it, not her doctor. States she is going to discuss it with him. States she doesn't want to have a worse reaction with the second dose. Caller states a headache is a headache but the pressure she felt within one minute and continuing it concerns her on the second one with the larger dose. States she is also concerned with the second dose if dizziness is a severe allergic reaction, not saying she fell over and wiped out. Patient wondering if that was an allergic reaction. States as the evening went on and she took Tylenol, it improved. States the dizziness improved as the night went on but had a bizarre feeling when she went to bed. States her arm was sore in the evening and is still sore to the touch. Clarifies that her eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something. States it was not like a tired and burning feeling, states she can't explain it but something felt like had an allergy type situation if she has a problem with seasonal allergies. Treatment included took Tylenol. States when someone has an autoimmune issue they have a lot of issues regarding the stomach and take a lot of vitamins and supplements. Caller states she wants to report she has a lot of food sensitivities and environmental sensitivities because of her Hashimotos. States anything can set off an immune response. States what happens with that is she would get on her face, angioedema near her ears and the gland secretes and the passage way swells up. States she takes Pepcid AC to treat it. States this did not happen with her first vaccine. States she was very hesitant on taking the vaccine because knows she has these issues and she didn't want to have adverse reactions. States that her reaction to the first vaccine potentially concerns her for the second dose. States going to speak with the medical information department is a good idea. States the location she received her vaccine was very busy. States they did a nice and good job on getting people in. States the girl administering it did good, but she didn't mention unless you knew you had to wait 15 minutes due to possible adverse reactions, they didn't really check on people. States she just had to do whatever and she didn't know whether or not to report it then because she was not in distress. States she thought she just has to get home and drove 30 miles. All events (AEs) did not require a visit to Emergency Room nor Physician Office. The events of Tunnel vision, rush of pressure to back of head and the lower part of head, Headache, dizzy/Dizziness/light headed, cloudy and pressure in her ears/Ear Pressure, was recovered on 01Apr2021, of my arm started to really hurt/Sore Arm; sore to touch was not recovered, of other events was unknown.
63 2021-04-24 headache, throat pain, body temperature increased, chills, dehydration, fatigue, sweating Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; ... Read more
Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.
63 2021-04-24 headache Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make... Read more
Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands; pain in arm; right ear & head pains; right ear & head pains; This is a spontaneous report from a contactable nurse, the patient, and based on information received by Pfizer from Abbvie Pharmacovigilance (Mfr. Control No.: 21K-163-3848385-00). A 63-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6207) intramuscular in the right arm on 18Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization; adalimumab (HUMIRA) solution for injection, subcutaneously, from an unspecified date at an unspecified dose and frequency for rheumatoid arthritis (RA). Medical history included polymyalgia rheumatica (PMR), RA, hypothyroidism, anemia. The patient had no known allergies. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included prednisone, levothyroxine sodium (SYNTHROID), folic acid, calcium carbonate (CAL). The patient did not receive any other vaccinations within 4 weeks of BNT162B2. On 18Mar2021 (within 4 hours of the vaccination), the patient experienced a rheumatoid arthritis flare up. The clinical course was as follows: on 18Mar2021 at 15:00, the patient experienced pain in elbow and finger pain (like trigger finger of both hands). On Mar2021 (within 24 hours), all fingers were involved, the patient's grip strength was decreased (she could not make a fist or grasp or grip/ inability to grip or grasp with her hands) and experienced left wrist pain. On Mar2021 (within 48 hours), the patient experienced finger edema, was still unable to make fist or grasp, experienced painful shooting pains up inner arms, right ear & head pains. The patient increased the prednisone dose to 4 mg daily as treatment for the events. On 21Mar2021 at 11:00 (72 hours after vaccination), the patient continued to experience bilateral arm pains, slight hand grips but could not lift, new right knee and right outer foot pains. On 21Mar2021 (94 hours after vaccination), there was less arm pain and finger edema, continued right ear/head pains. The patient saw the primary physician, there was no ear infection and the physician agreed with the prednisone increase. The physician felt the patient should not take the second vaccine dose and alerted the rheumatologist. On 22Mar2021 (116 hours after vaccination), the patient was able to lift and grasp with both hands, had less ear and arm pain. Since the vaccination, the patient was not tested for COVID-19. The action taken with adalimumab in response to the events was unknown. The reporter's causality for the events trigger finger, inability to grip or grasp with her hands, severe flare of RA symptoms 4 hours post vaccine, pain in arms and elbows, pain in ears was not provided. The clinical outcome of rheumatoid arthritis flare up, trigger finger, "grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands", pain in arm, right ear & head pains was resolving; while of pain in elbow was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the RA flare and other events. The reported events may likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
63 2021-04-24 fatigue, chills, headache some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headach... Read more
some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-04-27 fatigue, headache her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got ... Read more
her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient). A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation. Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported. On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
64 2021-01-01 fatigue, headache, fever Body aches, fever less than 101, headache, nausea, lymphadenopathy, fatigue ,loss of appetite
64 2021-01-03 fever, chills, fatigue LATE EVENING OF 12/30/20 DEVELOPED FEVER, CHILLS, VOMITING, BODY ACHES, AND FATIGUE. LASTED 3 DAYS. ... Read more
LATE EVENING OF 12/30/20 DEVELOPED FEVER, CHILLS, VOMITING, BODY ACHES, AND FATIGUE. LASTED 3 DAYS. IS NOW RESOLVED.
64 2021-01-04 chills, headache headache,nausea and vomiting ,chills
64 2021-01-05 fever, chills, throat pain, headache I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness o... Read more
I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness or swelling at the site. I couldnt lie on my left arm at all that night. By 11pm I also experienced headache, sinus drainage, sore throat, body aches, taste and smell were off, upset stomach, queezy stomach but no nausea or vomiting, very weak , dry mouth, fever at 99.2 then 98.6, chills, lots of chills. The covid hotline at my work told me I had a moderate reaction to the vaccine. Treatment was rest and tylenol which didn't alleviate any symptoms whatsoever. I had all these symptoms til Jan 6th at 4am. At 4am all the symptoms left and have not returned.
64 2021-01-05 chills Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hiv... Read more
Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hives/welts came up on right ear and behind neck/welts under buttocks and behind knees, welts were large and red; Slight chills; Tenderness in injection arm; was just a little cold; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PAA156571), via an unspecified route of administration in left deltoid on 28Dec2020 10:00 at 0.3 mL single for covid-19 immunization; sulfamethoxazole, trimethoprim (BACTRIM DS), at twice a day for 10 days for perineal cyst. The patient was on her last day of sulfamethoxazole, trimethoprim on the day she got the COVID-19 vaccine (28Dec2020). Medical history included perineal cyst, COVID-19 in Apr2020 with no problem, only had a cough. Husband had COVID-19 and had loss of taste and smell, had fever, but he was not serious. Both her and her husband got tested for antibodies and were positive. Family medical history was none. The patient had unspecified flu vaccine (Lot: UJ428AB) on 18Dec2020 injected in left deltoid in two weeks prior to COVID-19 Vaccine. Checked with three different people who stated the Flu vaccine would not interfere with COVID-19 Vaccine. Checked with two pharmacists who stated Bactrim DS would not affect her taking the COVID-19 Vaccine. She received COVID-19 Vaccine through her work in a nursing home. There were no additional vaccines administered on same date of Pfizer suspect. On 28Dec2020 about 7 to 8 hours after vaccination, patient had slight chills and tenderness in her arm: was just a little cold. Thirty-six hours after injection, midnight on 29Dec2020, her scalp itched like crazy, broke out in hives. On 30Dec2020, rash developed on both lateral sides of her breast, welts came up on right ear and behind neck. On 31Dec2020, welts under buttocks and behind knees, welts were large and red. Rash on lateral breasts: felt a bit of itching. The patient had blotchy rashes, rash up in her hair above her neck and back of ear, had intense itching; which subsided. It was a little pink on her chest, little itching on her head. Her ear was better. Symptoms were most mild because she was still able to function. Clarified as not serious. The patient was taking diphenhydramine (BENADRYL, Lot: SMF011, Exp: May2022) at 25mg every 3.5 to 4 hours, cortisone cream 10 Maximum Strength (Lot: 20K434, Exp: Sep2023) for rash and welts; and doing tepid soaks. It was tolerable and faded. Rash had subsided, but was a little red. Her greatest concern was what to do in regards to the second dose in three weeks. The reporter considered events were related with COVID-19 Vaccine. The action taken in response to the events for sulfamethoxazole, trimethoprim was unknown. The outcome of events was unknown.
64 2021-01-05 chills a slight chill the first night; slight tenderness to arms; This is a spontaneous report from a conta... Read more
a slight chill the first night; slight tenderness to arms; This is a spontaneous report from a contactable nurse reported for her identical twin sister. A 64-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included unspecified flu vaccine on 18Dec2020. The patient experienced a slight chill the first night and slight tenderness to arms on 28Dec2020 with outcome of unknown. Information about Lot/Batch number requested.
64 2021-01-06 lethargy, headache, fatigue, chills At twelve hours post injection I awoke with severe chills even though I did not have a temperature. ... Read more
At twelve hours post injection I awoke with severe chills even though I did not have a temperature. After taking 1000 mg of Tylenol the chills past in approximately an hour. The rest of the day I had extreme fatigue, headache, lethargy, and loss of appetite. By the next morning I still had the fatigue and weakness which improved gradually over the next 12 hours.
64 2021-01-06 headache, fatigue, fever, chills Fever, chills, body aches, headache, Fatigue, several days, now resolved
64 2021-01-06 fever, chills, influenza like illness Flu-like illness (fevers, rigors, chills) and one episode of presyncope due to orthostatic hypotensi... Read more
Flu-like illness (fevers, rigors, chills) and one episode of presyncope due to orthostatic hypotension upon getting up the day after the vaccine
64 2021-01-06 headache, fever Headache & Fever
64 2021-01-06 headache I exp headache and diarrhea The next day after I was urinating blood. I went to my PCP I got Culture... Read more
I exp headache and diarrhea The next day after I was urinating blood. I went to my PCP I got Culture and given antibiotics.
64 2021-01-06 headache Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and ... Read more
Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and pains. Slight dizziness. The next day, all symptoms gone. Injection site/sore arm for 3 days.
64 2021-01-06 cough, fatigue Patient contacted provider 12/26 with following symptoms: Dry cough, diarrhea, fatigue for 7 days. C... Read more
Patient contacted provider 12/26 with following symptoms: Dry cough, diarrhea, fatigue for 7 days. Covid test ordered and positive. presented to ED on 12/31 and admitted into hospital. Still inpatient as of 1/7/2021.
64 2021-01-06 fever, headache, chills fever, chills, headache, muscle and joint pain, duration 24 hours
64 2021-01-07 fever, influenza like illness, headache swelling; Flu like symptoms; low grade fever; headache; joint pain; This is a spontaneous report fro... Read more
swelling; Flu like symptoms; low grade fever; headache; joint pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) intramuscularly in the left arm on 18Dec2020 at 12:00 am, and the second single dose intramuscularly in the left arm on 04Jan2021 at 12:00 pm (as reported), for COVID-19 vaccination. Medical history included osteoarthritis from an unknown date and unspecified if ongoing. No unknown allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), hydroxychloroquine, progesterone, colecalciferol (VITAMIN D), calcium, magnesium. No other vaccine received in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced flu like symptoms, low grade fever, headache, joint pain and swelling on 05Jan2021 at 01:00 am. The events were non-serious. The patient received paracetamol (TYLENOL) and ibuprofen for the events. The patient was recovering from the events. Information on Lot/batch number has been requested.
64 2021-01-08 nasopharyngitis, fatigue Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should ... Read more
Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should go home or be reported. First shot had a sore arm & a bit of a cold for a few hours and back to work. This time has sore arm and is more tired than usual. 98.7 F No cough, HA, N/V. No medications taken for s/e.
64 2021-01-08 fever Nausea, diarrhea, low grade fever. Lasted 4 days, treated with Zofran
64 2021-01-08 fatigue, headache headache, sore arm, fever, body aches, tiredness
64 2021-01-09 chills, headache, body temperature increased About 24 hours after I got my injection I began to feel cold. I am by nature always cold but within... Read more
About 24 hours after I got my injection I began to feel cold. I am by nature always cold but within 30 minutes I began to shiver. This intensified and I got to the point I was shaking hard and so cold. I had also had a headache all day but that is not unusual for me as I frequently have sinus headaches that can last all day. I took my temperature which was 98.3 but I took Tylenol anyway realizing I was likely having a vaccine reaction. I got into bed under my electric blanket. Ninety minutes later I had finally warmed up. In fact my feet and hands felt like they were on fire. I rechecked my temperature and it was up to 100.9. I peeled off my numerous clothing layers and I actually felt better since the chilling had stopped. I ate some dinner and watched TV and went to be around 11pm. I slept fitfully which is normal for me. As the night wore on I began chilling again. I got up sometime around 5am and took more Tylenol. If I remember my temperature was around 100.1. I slept several hours and woke up feeling ?back to normal?.
64 2021-01-09 influenza like illness, body temperature increased Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu l... Read more
Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu like feeling
64 2021-01-09 fatigue, chills, headache, fever Fever (100.5 F oral temp) Body Aches Headache Chills Fatigue Pain at Right Deltoid Injection site
64 2021-01-09 chills, fever, headache, fatigue Fever (oral temp 100.5) Body Aches Chills Headache Fatigue Right arm pain
64 2021-01-09 lethargy, headache, fever Fever, headache, lethargy for 36 hours
64 2021-01-09 chills, headache, fatigue Violent chills, headache, abdominal pain especially on the right side and vomiting. Muscular aches... Read more
Violent chills, headache, abdominal pain especially on the right side and vomiting. Muscular aches all over the body. Fatigue. 1/10/21: Still experiencing headache and muscle pain, occasional chills.
64 2021-01-10 headache, fatigue, chills 8th Jan-1430-tired 9th Jan-tired, nauseated, aches/body, chills 10th Jan-nauseated, tired, chills, a... Read more
8th Jan-1430-tired 9th Jan-tired, nauseated, aches/body, chills 10th Jan-nauseated, tired, chills, aches-body 11th Jan -aches-body, tired, nauseated, Headache
64 2021-01-10 chills, headache, fatigue 8th Jan@1430-Tired 9th Saturday-tired, nauseated, aches, chills 10th Jan Sunday-nauseated, tired, ch... Read more
8th Jan@1430-Tired 9th Saturday-tired, nauseated, aches, chills 10th Jan Sunday-nauseated, tired, chills, aches-body 11th Jan Monday-aches-body, tired, nauseated, Headache-Treatment-none, When she can she eats a little & drinks when not nauseated
64 2021-01-10 cough, nasal congestion Diagnosed with COVID-19, Cough, Congestion, Mild Respiratory Illness
64 2021-01-10 headache, chills, fever Headache Neck pain Fever/Chills Nausea/Vomiting Diarrhae
64 2021-01-10 malaise, chills Patient had the vaccine on Friday (2:30pm) and was fine. Saturday then she had a sore arm. She went... Read more
Patient had the vaccine on Friday (2:30pm) and was fine. Saturday then she had a sore arm. She went to work and was fine (10 hour shift). She had Gammagard around 6pm and then the infusion was fine and went on as normal (a little burning at the beginning), then chills at the end (not unheard of). An hour later she went to sleep since not feeling 100%. She woke up with severe chills, headache, body aches all over, She has bad chills and is shaky. She went home and no fever. Her eyes are kind of burning. She has a call with her doctor today.
64 2021-01-10 chills, headache blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot;... Read more
blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-01-11 nasopharyngitis 10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hip... Read more
10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hips & legs. Couldnt stand up. 24hs Later symptoms gone.
64 2021-01-11 headache, chills APPROXIMATELY 30 HOURS AFTER VACCINE I NOTICE SORENESS AND A VERY HOT, RED, SWOLLEN, ITCHY AREA AT... Read more
APPROXIMATELY 30 HOURS AFTER VACCINE I NOTICE SORENESS AND A VERY HOT, RED, SWOLLEN, ITCHY AREA AT INJECTION SITE APPROXIMATELY 3 INCHES ACROSS. THIS KEPT SPREADING UNTIL 12 HOURS AFTER THAT WHEN I TOOK BENEDRY L AND THAT TOOK AWAY A LOT OF REDNESS, HEAT, AND RECEEDED SLIGHTLY. THE BENEDRY HELPS BUT HAS NOT TAKEN IT AWAY. ALSO HAD THE EXPECTED REACTION 14 HOURS AFTER VACCINE OF FEVER, CHILLS, BODY ACHES, & HEADACHE FOR 48 HOURS WHICH IMPROVED EACH DAY.
64 2021-01-11 chills, fever, throat pain, headache, cough Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including finger... Read more
Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain
64 2021-01-11 headache I developed a headache, burning of my face and upper gums 45-60 minutes after the vaccine. As the ... Read more
I developed a headache, burning of my face and upper gums 45-60 minutes after the vaccine. As the day went on I developed slight swelling of my upper lip. The burning of my face lasted until the following day but then would come and go. The swelling of my upper lips lasted 4 days. Last Thursday 1/7/2021 my face was burning and lasted the day.
64 2021-01-11 chills, sweating Nausea; Chills; sweats; vomit; This is a spontaneous report from a non-contactable consumer (patient... Read more
Nausea; Chills; sweats; vomit; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on 02Jan2021 14:15 at SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included depression from an unknown date. Concomitant medication included marijuana, depression meds and sleep meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 04:00, the patient experienced nausea, chills, sweats and vomit. The patient did not receive any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
64 2021-01-11 sweating Pfizer-BioNTech COVID-19 Vaccine EUA 64-year-old female presents as a rapid response team patient st... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 64-year-old female presents as a rapid response team patient status post immunization her second shot was done on Tuesday 2 days ago. She had some diarrhea last night and had some body aches in her arms following the rules today she woke up did not eat breakfast which is not abnormal for her did have some coffee came to work describes some myalgias and felt sweaty felt chilled so she went downstairs had a glass of orange juice to see if that would help had a small helping of hashbrowns did not help she was so she went to employee health in the then was sent here for further evaluation. Patient denies any heart or lung problems high blood pressure diabetes has URI symptoms. No history of PEs or DVTs denies hypertension she fell your blood sugar is low but has no documented history of hypoglycemia is not on any hypoglycemic medications. No history of PEs or DVTs no travel or surgeries. No nausea or vomiting with the diarrhea. Also complains of body aches.BP 120/69 | Pulse 76 | Temp 37 °C (98.6 °F) (Oral) | Resp 21 | Ht 1.676 m (5' 6") | Wt 198 lb (89.8 kg) | SpO2 95% | BMI 31.96 kg/m² Labs reviewed on the chart are normal symptomatically she feels better offered Toradol for myalgias she refused she I suspect is having a reaction/side effect not an allergic reaction to her vaccination she received. Patient discharged.
64 2021-01-11 fatigue Recipient reported heartburn sensation, chills, fatigue.
64 2021-01-11 fatigue, fever, malaise, chills at day 18 or 19, post first covid vaccine shot, I began to have many symptoms and did not feel well.... Read more
at day 18 or 19, post first covid vaccine shot, I began to have many symptoms and did not feel well. These were chills, slight fever, no appetite, nausea, muscle aches, fatigue
64 2021-01-11 chills, fatigue, headache fatigue; Nausea; Headache; chills; This is a spontaneous report from a contactable other health care... Read more
fatigue; Nausea; Headache; chills; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 64-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number: EK9231, Intramuscular on right arm on 05Jan2021 at single dose for COVID-19 immunization. Medical history included Covid-19 and allergy to penicillin. Concomitant medications were not provided. Patient did not receive other vaccine in four weeks. On 05Jan2021 patient experienced nausea, headache, chills, fatigue. She was not treated for the events. Patient had not been tested for COVID-19 post vaccination. Patient was recovering from the events, at the time of the report.
64 2021-01-12 cough After the vaccination I developed a non productive cough, had creepy crawly feeling skin and felt as... Read more
After the vaccination I developed a non productive cough, had creepy crawly feeling skin and felt as if my eyes were burning but no fever develop. I got tested for COVID via rapid/PCR test on12/25 which was neg but got retested on 12/28 via the rapid COVID test and was positive then.
64 2021-01-12 malaise, fever, chills, headache Arm soreness @ 11pm 1/11/2021; continual headache starting @ 2am 1/12/2021 accompanied by chills,... Read more
Arm soreness @ 11pm 1/11/2021; continual headache starting @ 2am 1/12/2021 accompanied by chills, low grade temp of 99.7 , skin hurt all over & generally feeling unwell. These symptoms continued until 11 pm 1/12/2021. Took Tylenol, wet to bed & woke up 1/13/2021 without symptoms.
64 2021-01-12 fatigue, chills Body aches Muscle soreness Chills Fatigue
64 2021-01-12 chills, malaise Chills, body aches, malaise, nausea
64 2021-01-12 headache, chills, lethargy, fever Headache Fever Chills Lethargy DIzzy
64 2021-01-12 headache I developed a headache and nausea that lasted 36 hours. Headache gone after the 36 hours but still h... Read more
I developed a headache and nausea that lasted 36 hours. Headache gone after the 36 hours but still have some nausea 48 hours later. I am fine, but wanted to at least let you know that's how the second shot affected me. I had no reaction other than a sore arm after the first injection. I did not need to seek medical attention.
64 2021-01-12 fever I had server out break of HSV 1 for 10 days , low grade fever 99. and anti-viral Vancylerver, Ty... Read more
I had server out break of HSV 1 for 10 days , low grade fever 99. and anti-viral Vancylerver, Tylerol and Advil
64 2021-01-12 cough, respiratory tract congestion Numbness of tongue, change in taste, congestion, body aches, diarrhea, cough
64 2021-01-12 fatigue, cough PAIN INJECTION SITE,TIRE,MUSCULAR PAIN,JOINT PAIN,COUGH AND TARDICARDIAC.
64 2021-01-12 influenza like illness, nasopharyngitis, fatigue Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to... Read more
Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to work and had to leave. Patient reports night sweats, severe fatigue. Patient says the night sweats is the reason she is calling.
64 2021-01-12 fatigue, chills, fever, headache Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Sev... Read more
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days
64 2021-01-12 fatigue, chills, headache, fever Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Sev... Read more
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days.
64 2021-01-12 fever, fatigue, body temperature increased, headache, fatigue, headache, fever Systemic: Exhaustion-Mild, Systemic: Fever-Mild, Systemic: Generalized Body Aches -Mild, Systemic: H... Read more
Systemic: Exhaustion-Mild, Systemic: Fever-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Headache-Mild, Systemic: patient experienced pain when taking deep breaths but was positive for covid in march2020 and out of work until june 2020. last covid swab was 12/22(negative)and 12/29. temperature was 99.6 and pulse
64 2021-01-12 fatigue Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle ... Read more
Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle of night with severe bilateral leg pain, similar to sciatica, painful to get out of bed and walk, similar to Charlie Horse. She took Tylenol and laid around most of the day 1/11/21. Pain in right leg stopped in evening on 1/11/21, however pain continues in left leg. Nerve pain in left leg is still continuing from left gluteal muscle to inner thigh above knee cap. She declined occupational health follow-up and will self-manage at home. Pfizer-BioNTech COVID- 19 Vaccine
64 2021-01-12 fever, influenza like illness awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu... Read more
awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu-like sx lasted for one day; fever resolved by this am 1/13
64 2021-01-12 headache felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous repor... Read more
felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous report from a contactable other HCP (patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided) via an unspecified route of administration (vaccination location: left arm) on 06Jan2021 09:30 at SINGLE DOSE for COVID-19 immunisation. Medical history was reported as 'none'. It was also reported that patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, and prior to vaccination, the patient was not diagnosed with COVID. The patient has no allergies to medications, food, or other products (no known allergies). The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899; expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 18Dec2020 18:00 at SINGLE DOSE for COVID-19 immunisation. It was reported that patient received second dose of Pfizer Covid vaccine on 06Jan2021 at 09:30 am. One hour after the 2nd dose (10:30 am), patient experienced dull occipital headache. Patient took paracetamol (TYLENOL). At 10:45 am, patient felt flushed. The nurse took patient's vital signs and noted no fever, normal heart rate and respiratory rate. BP elevated 226/97 (reported at 10:30, no unit provided; normal BP: 130's/80's). At 12:45, patient was taken to ED. CT scan and lab work were reported as all normal. BP continues to be elevated. Amlodipine (NORVASC) 10 mg was given at 17:00. BP slowly came down. Twenty-four hours later, BP was normal at 137/72 (no unit provided). No additional medication taken. It was reported that patient continues to have dull headache. No arm soreness or other symptoms. It was also reported that since the vaccination, the patient has not been tested for COVID-19. Outcome of the events 'BP elevated 226/97' and 'felt flushed' was recovering, outcome of the event 'dull occipital headache/dull headache' was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, the Company considers the reported event blood pressure increased is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-01-13 headache 45 min after injection face became red and flushed and headache began, redness left in about 4 hour... Read more
45 min after injection face became red and flushed and headache began, redness left in about 4 hours, headache still remains 24 hours later but mild. joints ache for 24 hours and neck slightly stiff after about 12 hours
64 2021-01-13 fever, chills, headache Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion;... Read more
Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion; chest tightness by day 3- increased swelling of arm with redness; hot to touch; increased pain radiating to under arm.
64 2021-01-13 body temperature increased, body temperature increased Received Covid Vaccine on Jan 13, 2021. Woke up on January 14, 2021 with a temperature of 103
64 2021-01-13 body temperature increased, headache Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 sof... Read more
Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 soft formed in 9 hours) resolved about 30 hours from onset.
64 2021-01-13 headache headache, body aches
64 2021-01-14 headache Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive saliv... Read more
Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive salivation with nausea, lightheadedness, she has a h/o migraines headaches and was incapacitated for 24 hours, Employee she was treated and sent home by end of her scheduled shift
64 2021-01-14 chills, fever Fever 101, chills, Arthralgia, red,hard sore painful left deltoid. Treated with Tylenol, Doxycycline... Read more
Fever 101, chills, Arthralgia, red,hard sore painful left deltoid. Treated with Tylenol, Doxycycline started on 1/15
64 2021-01-14 cough, headache, fever Fever, headache, lightheaded and mild cough.
64 2021-01-14 body temperature increased Patient had an elevated temperature that reached a maximum of 102.5 before resolving.
64 2021-01-14 fatigue, chills, fever a few hrs. after receiving the vaccine patient had swelling to bilateral hands and feet. patient als... Read more
a few hrs. after receiving the vaccine patient had swelling to bilateral hands and feet. patient also developed weakness, fatigue and had chills unknown if she had fever Patient was seen by family MD after a few days of swelling
64 2021-01-14 throat pain, fever, lethargy, headache, cough almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in he... Read more
almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in her mouth, white tongue; felt a little cold; legs were sore; headache; Sore arms; severe sore throats; back ache; low grade temp/Low grade fever; coughing; body aches/ whole body was achy; it was sore to swallow; lethargy; This is a spontaneous report from a contactable consumer reporting for self. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EL1284, Expiry Apr2021, intramuscularly on 30Dec2020 02:15 (Dose 1), right arm as a single dose (age at vaccination 64 years old) for COVID-19 immunization. Medical history included allergy (usually in the fall she has allergy problems). Her age is considered high risk, works in medical profession (Surgical Tech). Concomitant medication included levocetirizine (Walgreen's generic) 5mg, tablet, by mouth, at night for allergy. The patient had the first dose of the vaccine last 30Dec(2020) and after 2 days (on 01Jan2021) she developed symptoms: Sore arms, severe sore throats, back ache/ back was sore, temperature was up / low grade temp (never high), coughing, body aches. Her back and her legs were sore. Her whole body was achy. It was "like flu-ish kinda." She also had a headache. She started getting the sore throat and headache on 01Jan2021, and she felt a little cold on 02Jan2021. On 02Jan(2021), her first temperature was 100.5 degrees Fahrenheit. She states she had everything except for the GI issues. Around 02Jan(2021) or 03Jan(2021), her symptoms were progressively getting worse. She was told to get COVID tested. There were three exposures since Christmas Eve. So, she went and got a rapid COVID test (04Jan2021) and it came back negative. They also sent out a test that day. She was also tested for Strep (04Jan2021) too because her throat was so sore. It was almost like she had like thrush along with it. She states it was almost like a thrush because she had like a white tongue (onset 03Jan2021). Her throat was so sore, but it was a different kind of sore throat compared to a sore throat she has had before. She explains where the nasopharynx was at the top, it's almost like it was sore from there. It was sore to swallow, it was "a bizarre sore throat." She clarified she noticed the "thrushy" part of her throat around 03Jan2021. The strep test ended up being negative but she believes she had thrush because she was given medication and the medication was clearing that up. However, she still had the symptoms. Because her symptoms only started a few days before, they thought she should maybe wait a couple of days and if she is not feeling any better, she should be retested (for COVID). She went back again yesterday (07Jan2021). She had another Rapid COVID test and also a flu swab and both tests came back negative. She mentions they also did another COVID test (the send out type) and she should get that back around 1pm to find out the results of that. They also did a CBC (07Jan2021) and everything was normal. Her white count was at 7. She was waiting for the 3rd COVID test result today (08Jan2021). She reported that about three days afterwards, she didn't notice the soreness in /her arm. Her throat has improved. Her fever was down to 98 degrees Fahrenheit yesterday (07Jan2021). She states she was feeling better today (08Jan2021). She commented "the lethargy, though." She emptied the dishwasher yesterday (07Jan2021) and had to sit down after emptying it. She states her symptoms have her a little worried. She recovered from the sore arms in Jan2021. The patient was recovering from the severe sore throat, back ache, low grade temp, coughing, body aches/ whole body was achy, believes she had thrush, white tongue, legs were sore, headache, and felt a little cold. The outcome of the event lethargy was not recovered. She was wondering if this was a reaction to the vaccine.
64 2021-01-14 headache, fatigue burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizzi... Read more
burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizziness; fast heartbeat; tiredness; Had a hard time swallowing at night from the dryness; bitter taste; her mouth went completely dry; patient received 0.45 mL, single dose (225mcg) of PFIZER-BIONTECH COVID-19 VACCINE; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 23Dec2020 15:00 at 0.45 mL, single dose (225mcg) at left arm to prevent COVID. Medical history included a bout of dry mouth about 7 years ago, no other relevant medical history (including any illness at time of vaccination). The patient's concomitant medications were not reported. There's no adverse events following prior vaccinations. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. From the time she got the vaccine her mouth went completely dry on 23Dec2020 and she kept thinking it would go away and she still had it. Event was reported as serious per medically significant. Had a hard time swallowing at night from the dryness. Patient had the bitter taste was also on 23Dec2020, but it went away. It lasted about 5-6 hours. Then after that the dry mouth started right after. It is tolerable but she still had it. Mentioned she had a bout of dry mouth about 7 years ago and it did go away, but she never got a diagnosis for it. Patient thought that something underlying may have triggered it again. Patient also experienced burning of the tongue, tiredness, headaches, pressure in the chest area similar to difficulty in breathing, nausea, dizziness, and a fast heartbeat on unspecified date. Outcome of event dry mouth was not recovered, outcome of event bitter taste was recovered on unspecified date in Dec2020, outcome of other events was unknown. No family medical history relevant to adverse events. No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Relatedness of Pfizer BioNTech Covid-19 vaccine with dry mouth and bitter taste per primary source reporter with method of assessment of global Introspection was related. Reporter seriousness for event bitter taste was not serious.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of dry mouth cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-01-14 chills chills; extremely painful injection site and was unable to lift affected arm over head easily; extre... Read more
chills; extremely painful injection site and was unable to lift affected arm over head easily; extremely painful injection site and was unable to lift affected arm over head easily.; This is a spontaneous report from a contactable nurse. A 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (anatomical location: arm left) from 07Jan2021 18:00 to 07Jan2021 18:00 at SINGLE DOSE for an unspecified indication. Medical history included known allergies: PCN. There were no concomitant medications. On 08Jan2021 at 12:00, The patient experienced extremely painful injection site and was unable to lift affected arm over head easily and then chills. The patient did not received any treatment for the events. Outcome of the events was recovering.
64 2021-01-17 headache, fatigue Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administra... Read more
Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administration. Effects lasted for 3 days despite round the clock Tylenol dosing.
64 2021-01-17 headache, fatigue Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. ... Read more
Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. tiredness and muscle soreness, intermittent nausea lasted for 5 days
64 2021-01-17 headache, nasal congestion, fever, fatigue Symptoms started at 10:30 PM on 01/04/2021, complains of headache, body aches, temp 100.4, congestio... Read more
Symptoms started at 10:30 PM on 01/04/2021, complains of headache, body aches, temp 100.4, congestion, fatigue. Took Tylenol for fever.
64 2021-01-17 cough, headache, chills severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hour... Read more
severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hours; This is a spontaneous report from a contactable other Health Professional (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), via an unspecified route of administration on 07Jan2021 10:30 at single dose in right arm for covid-19 immunization. Medical history included hypertension (Htn), chronic kidney disease (CKD), the patient had known allergies to ibuprofen, bee stings. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899), on 17Dec2020 at the single dose for covid-19 immunization and experienced very sore arm. Concomitant medications the patient received within 2 weeks of vaccination reported as yes. The patient experienced severe headache, nausea, chills, sinus pain, cough, and joint pain for 24 hrs; headache and nausea continued another 12 hours. Bedridden first 24 hours. Arm still sore at 60 hours on 07Jan2021 22:00. The patient did not receive any treatments. The outcome of the events was recovering.
64 2021-01-17 chills, fatigue, headache very sore arm, headache, muscle aches, tiredness, chills
64 2021-01-18 fatigue, headache Headache, body aches, headache, extreme fatigue
64 2021-01-18 fatigue, sleepiness, chills Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, esp... Read more
Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, especially shoulder blades; tired/sleepy; tired/sleepy; chills; This is a spontaneous report from a contactable other HCP (patient). This 64-year-old female other HCP reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL128H), via unspecified route at right arm on 08Jan2021 07:45 AM at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included elevated blood pressure and atrial septal defect repair 2008. Concomitant medications included olmesartan medoxomil and hydrochlorothiazide. Historical vaccine included the first dose of BNT162B2 (lot# EH9899) on 18Dec2020 at age of 64 years old for COVID-19 immunization and having arm pain. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. On 08Jan2021 07:00 PM, patient experienced pain at injection site, swelling (size of her palm), warm to touch all over body and muscle aches, especially shoulder blades, very tired/sleepy with chills. No treatment was received. It was reported normal temperature for patient was 97.2 (+) or (-) 98.6. Outcome of events was recovering.
64 2021-01-18 fatigue, sleepiness Physical exhaustion, slept all afternoon, Got up around 6PM and went back to bed at 9 and slept fro... Read more
Physical exhaustion, slept all afternoon, Got up around 6PM and went back to bed at 9 and slept from 9 AM till the next morning at 8AM. Felt tired all morning and no appetite ,and felt nauseous. Began feeling better around 2 PM.
64 2021-01-18 fever, respiratory tract congestion, throat pain, nasal congestion, cough She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COV... Read more
She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse (patient herself) reported that a 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date not reported), via an unspecified route of administration in the upper left arm on 21Dec2020 17:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing hypertension (blood pressure high). She was a former smoker, a teenage smoker. She has not smoked since the age of 19 years old. Concomitant medication included amlodipine for high blood pressure. The patient informed that she was vaccinated on 21Dec2020. On 05Jan2021, she had a positive COVID Test and she was wondering when she should have the second dose of the COVID Vaccine. She thought initially she just had a cold. She took the COVID test as a precaution. It started out with a stuffy nose. She had a congested cough, upper airway cough, nothing deep in the lungs. She had a low grade fever. It was like 99.9. It was possible it was higher, but she had taken Ibuprofen at night. She woke up soaking wet. She had sweats kind of. Her temperature however never registered a true fever if a fever was considered 100.4. She was not really having body aches any more unusual than one would have for a 64 year old. She has a very mild sore throat. Her stuffy nose had improved, it's still there slightly, but not like it was the first few days. The outcome of events was unknown.; Sender's Comments: Test positive for covid19 found 14 day following the first dose of COVID-19 vaccination, bnt162b2, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
64 2021-01-18 fever, chills Sore arm the next morning , not bad Almost exactly 24 hrs later, fever, chills and achiness.
64 2021-01-18 fever Started feeling achy; temperature of 99.2; Sore arm; This is spontaneous report from a contactable c... Read more
Started feeling achy; temperature of 99.2; Sore arm; This is spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on 08Jan2021, temperature of 99.2 and started feeling achy on 09Jan2021. Event details: The patient received the first dose of the vaccine yesterday (08Jan2021). Yesterday night, she started with a sore arm which she expected then this afternoon (09Jan2021) she started to experience feeling achy and when she checked her temperature it was 99.2, for the sore arm last night and this morning she took Ibuprofen for treatment. The outcome of the events was unknown. Information on the batch/lot number has been requested.
64 2021-01-18 chills, fever right groin became red and develop lymph node; right groin became red and develop lymph node; Fever/... Read more
right groin became red and develop lymph node; right groin became red and develop lymph node; Fever/ temperature went up around 101.4; Chills; This is a spontaneous report from a contactable nurse (patient). This 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was a nurse anaesthetist who received the COVID-19 vaccine on the 19Dec2020 and on 22Dec2020 after she got home from work that afternoon in the evening, her temperature went up around 101.4 and had the chills and the fever. Later that evening and next morning (23Dec2020) her right groin became red and develop the lymph node that patient did not never felt before. Patient called physician and they put her on Antibiotics Keflex (treatment) for four times a day for 10 days. After the reaction, patient had a COVID test and Flu A and Flu B test and all of them were negative. The outcome of events was unknown.
64 2021-01-19 fever, headache FEVERISH; HOT FLASHES; MUSCLE ACHES; MILD HEADACHE; SORE ARM. TOOK ADVIL 600MG 2X DAILY
64 2021-01-19 fever Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji ... Read more
Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji think clearly. Residual symptoms at the time of this report
64 2021-01-19 chills, headache, fever I experienced chills; mild headache; fever ranging from 100.8 - 101.8; Mild body aches; This is Spon... Read more
I experienced chills; mild headache; fever ranging from 100.8 - 101.8; Mild body aches; This is Spontaneous report from a contactable consumer. A 64-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 08Jan2021 at 01:00 PM at single dose for COVID-19 immunization. The patient had a medical history of Rheumatoid Arthritis, Sjogren's Syndrome, Osteoarthritis and known allergies to penicillin, Valium, ketamine. Concomitant drug included Synthroid and Humira - Abbvie on 31Dec2020 (lot number 1136949). On 09Jan2021 approximately 24 hours after BNT162B2 administration, the patient experienced chills, mild headache and fever ranging from 100.8 - 101.8 and mild body aches. 48 hours later she still had fever ranging 100-101. No treatment was received. The patient did not have Covid prior vaccination and was not covid tested post vaccination. At the time of reporting the patient was recovering.
64 2021-01-19 fever, headache, fatigue, chills On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore... Read more
On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore with a knot at injection site. Nausea and fever of 101.8-patient took Zofran=8mg. All over body aches and joint tenderness and soreness. Day 3-1/9/21-extreme fatigue and body aches, no fever or chills. Day 4 and 5 only had headaches, and on Day 6 no symptoms at all.
64 2021-01-19 fatigue Worsening diarrhea at onset followed by significant fatigue, weakness, and vibratory sensation in ar... Read more
Worsening diarrhea at onset followed by significant fatigue, weakness, and vibratory sensation in arms and legs Exam on 19 Jan 2021 revealed hyperreflexia and slightly spastic gait concerning for transverse meylitis
64 2021-01-20 headache Approx. 10-12 post immunization, pt. reports dizziness and nausea. She refused to lay down, remained... Read more
Approx. 10-12 post immunization, pt. reports dizziness and nausea. She refused to lay down, remained in wheelchair. She asked for cola, it helped settle stomach. As dizziness subsided she had HA. We observed her for an additional 30 min. until dizziness gone. She still had some nausea & HA. Hx: migraines. (She often feels dizzy/nausea prior to migraines)
64 2021-01-20 headache, body temperature increased Elevated T of 100.3, body muscle/joint pain; severe headache, nausea, dizziness
64 2021-01-20 chills, fatigue Patient received her first dose of the Pfizer vaccine on 1.20.2021. Patient reports chills, fatigue,... Read more
Patient received her first dose of the Pfizer vaccine on 1.20.2021. Patient reports chills, fatigue, and heel numbness. The heel numbness began the night of the injection. Patient said half of their left foot and heel felt numb. Patient states that the numbness has fully resolved by the next morning, 1.21.2021. Patient encouraged to call PCP with worrisome or bothersome problems. Patient encouraged to call back with any new changes or questions about the vaccine.
64 2021-01-20 fever low grade fever, chills, aches, sensitivity to light, shakes
64 2021-01-21 chills, headache chills, skin hurts, headache, nausea, body aches, muscle aches
64 2021-01-22 fever, fatigue, chills, headache Chills, fever, headache, muscle pain, fatigue, weakness
64 2021-01-23 chills, body temperature increased, fatigue, headache I am reporting the following reaction, as I was unable to enter it on V-safe due to the site not fu... Read more
I am reporting the following reaction, as I was unable to enter it on V-safe due to the site not functioning properly. Twelve hours post vaccination: onset of shaking chills, temperature 101 F, severe headache, nausea, myalgia, arthralgia and fatigue Twenty four hours post vaccination: severe headache and moderate nausea, myalgia, arthralgia and fatigue, temperature 98.8F Forty eight hours post vaccination: moderate headache, mild nausea and fatigue Seventy two hours post vaccination: slight headache, nausea and fatigue Ninety six hours post vaccination: symptoms resolved
64 2021-01-23 headache, fatigue Moderate Fatigue and body aches, moderate headaches
64 2021-01-23 headache, sleepiness, chills chills, headache, nausea, sleepiness, body aches for 2 days. Took Tylenol every 4 hrs. for 24 hrs. ... Read more
chills, headache, nausea, sleepiness, body aches for 2 days. Took Tylenol every 4 hrs. for 24 hrs. Felt better by day 3.
64 2021-01-24 fatigue Have written to Health dept no answer-they must be busy. First shot resulted in very sore upper arm ... Read more
Have written to Health dept no answer-they must be busy. First shot resulted in very sore upper arm 1.5 days, no other effects. Clean injection into deltoid muscle bulk. Second shot, injection shot extremely high above main muscle bulk of the deltoid into area of supraspinatus tendon one finger below acromial shelf. First shot, two sensations: initial puncture then injection. Shot 2 one huge painful bump met with resistance in my tissue. Also Shot 2 not one response except mild fatigue still today, but no pain in upper arm unless I pressed specifically into injection site itself. WAS THIS VARIATION IN INJECTION SITE ACCEPTABLE? WAS IT OK TO DO INJECTION SO VERY HIGH UP? Secondly, had a wonderful, professional nurse, but I question the practice of retrieving a dose for me that comprised of doses left over at bottom(s) of other vial(s). We had a new vial in the office where I was, but she left and came back with a syringe already full, saying that it was important to use up every drop. At first I agreed, but now I question this practice and just want to make sure I don't need to come back for another second dose. Are there no substrates that would settle out of the solution as the vial gets depleted of everything except only a bit of fluid left in it? Is retrieving every last drop from each vial and putting them together to make a dose acceptable practice? if not, from the Pfizer standpoint, then I should get another dose? I am a pediatric physical therapists working within 1-2 feet a children's faces at all times and transmissibility is a real issue both ways in my job. I truly do not want o become a Covid victim. please let me know if both the injection site and the method b y which my dose was put together is acceptable in the eyes of Pfizer. Thank you.
64 2021-01-24 headache bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time)... Read more
bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time) confusion; lightheadedness; headache/slight headache; This is a spontaneous report from a contactable nurse, reporting for herself. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EL1284), intramuscularly on the left arm on 05Jan2021 18:30 at a single dose for COVID-19 immunization. Medical history included received immunotherapy injections for environmental allergies from an unknown date and unknown if ongoing. Concomitant medication included diltiazem, spironolactone, trazodone, lorazepam, colecalciferol (VITAMIN D), zinc and fish oil. On 05Jan2021, the patient received Pfizer COVID-19 vaccine and experienced (time) confusion, and lightheadedness within one hour of receiving. Later that evening, the patient experienced headache. On 06Jan2021, the patient experienced injection site soreness x 2 days, continued with slight headache, lack of energy. On 08Jan2021, resolved injection site soreness of left arm, continue with slight headache. On 11Jan2021, The patient woke up with bloodshot left eye after having had headaches x 5 days which began the same evening of receiving the Pfizer COVID-19 vaccine. Blood pressure was 125/80. No headache or eye pain. BP was 128/89 on 10Jan2021, 11 PM. No headache. BP was 120/80 on 11Jan2021, 10 AM. The patient had never had a bloodshot eye before. The patient underwent lab tests and procedures which included Blood pressure:125/80 mmHg on an unspecified date, 128/89 mmHg on 10Jan2021 and 120/80 mmHg on 11Jan2021. The outcome of the event injection site soreness/injection site soreness of L arm was recovered on 08Jan2021 while the outcome of all other events was unknown.
64 2021-01-24 fever, fatigue forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most... Read more
forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation. Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
64 2021-01-24 fever, fatigue ran low grade fever 12/19/2020 ,12/20/2020 Fever, fatigue 12/22/2020 sever diarrhea , 12/26/2020 fe... Read more
ran low grade fever 12/19/2020 ,12/20/2020 Fever, fatigue 12/22/2020 sever diarrhea , 12/26/2020 feeling worse and worse and tested on 12/26/2020 on 12/28-29/2020 shortness of breath and admitted on 12/31/2020
64 2021-01-25 fatigue, chills, fever, cough Has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth ... Read more
Has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth bones in her hands; She still has a cough and no taste; She still has a cough and no taste; The doctor didn't know what to tell, they said if they were her, they would not take the second shot; Body aches; Chills; Nausea; Tired; Diarrhea; Had a fever reached 100.0; Joint hurt, all of them; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 in Nov2020 (8 weeks ago). Concomitant medications were not reported. After getting the vaccine, she got sick as a dog and couldn't work. She had a fever that reached 100.0, she had body aches. It was explained that she has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth bones in her hands. The caller continues that her joint hurt, all of them, but it was throbbing the most where she has visual arthritis. To sum it up, she had chills, nausea, and body aches the first day. The caller took Tylenol regardless of what the paper said; this was on Friday, 08Jan2021. She kept taking the Tylenol. The next day, she was still tired but when she quit taking the Tylenol on the 2nd day the symptoms returned. It was clarified that she took it in the beginning of the second day twice but at the end of the day wanted to see if she was over it all so she stopped the Tylenol. The symptoms all returned so she took again at bed time, the Tylenol, this was Saturday. On Sunday, she had diarrhea but only a couple times and though it was weird, after that is was over. That day she took Tylenol once. She was calling because she was scared about the second dose, this one produced a big immune response and she says that usually happens with the second dose. The caller wants to know if she should take the second shot, she doesn't want to have this happen again or it be worse. She thought since she had already had COVID it wouldn't be as bad, her immune response. The first dose was given on 07Jan2021. It was explained the only thing unresolved was from when she had COVID, she still has a cough and no taste. There are just few thing she can taste and smell now. The patient said that all the symptoms had resolved as of Monday, the 11Jan2021. Actually, she felt pretty good on the 10Jan2021 so let's say Sunday. She explained that most people get this on the second dose and so if she going have a third response she doesn't want the second dose. She was calling to get an answer to her question, the doctor told her to call to see what could be recommended. She has really good doctors, three of them. The doctor didn't know what to tell, they said if they were her, they would not take the second shot. The patient said she really needs to go. No need to continue when there is no one to tell her if she should take the second shot or not. The patient asked to be contacted via email to relay information about people's immune response to the first dose verses the second dose, is it greater or less. Clinical outcome of the events recovered on 11Jan2021. Information on the Batch/Lot number has been requested.
64 2021-01-25 fever, headache, chills Heaviness in chest; Chills; Headache; Body aches; 20 Hours after vaccination; fever of 100.5; This i... Read more
Heaviness in chest; Chills; Headache; Body aches; 20 Hours after vaccination; fever of 100.5; This is a spontaneous report from a contactable Nurse reported for herself. A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 16:00 at single dose on left arm for COVID-19 immunisation. Medical history included Anxiety, GERD, gluten and lactose intolerant, no known allergies, no COVID prior to vaccination. There were no concomitant medications. There were no other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 in Dec2020 13:00 in Left arm for COVID-19 immunization. About 20 Hours (as reported) after vaccination, on 14Jan2021 at 11:00 AM, the patient experienced fever of 100.5, headache, body aches, heaviness in chest, chills. No treatment was received for the events. The patient had not recovered from the event. The patient didn't test COVID post vaccination. Information on the lot/batch number has been requested.
64 2021-01-25 headache Nausea and Vomiting this morning at 8:30 am on 1/26/21. Slight headache yesterday.
64 2021-01-26 cough A cough and then vomiting
64 2021-01-26 headache, chills, fever Fever to 101.2 x 12 hrs. Continued fever at 100 through 24 hrs. Total body aches. Chills. Nausea... Read more
Fever to 101.2 x 12 hrs. Continued fever at 100 through 24 hrs. Total body aches. Chills. Nausea. Severe headache. All mostly resolved in a total of 36 hrs.
64 2021-01-26 headache Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and l... Read more
Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and left collarbone and neck; edema left arm pit and left collarbone and neck; tingling down the back of neck to shoulder blade for 1 week; All left side, pain at injection site with warm to touch for three days; All left side, pain at injection site with warm to touch for three days; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via intramuscular in left arm on 08Jan2021 13:15 at second single dose for covid-19 immunization. Medical history included diabetes type 2, allergies. Concomitant medication included metformin, simvastatin, semaglutide (RYBELSUS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose BNT162B2 (LOT# EL1685) on 20Dec2020 01:15 PM, via intramuscular in left arm for Covid-19 immunization. The patient experienced headache and body aches for 24 hours, edema under left arm pit and left collarbone and neck with tingling down the back of neck to shoulder blade for 1 week. All left side, pain at injection site with warm to touch for three days. Adverse event start date/time: 09Jan2021 06:00 AM. Events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was recovering.
64 2021-01-26 headache Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving d... Read more
Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving dose, felt extreme coldness from shoulder to tips of fingers for about 30 mins and then resolved. Then afterwards, started to develop redness/itching/hives on back. Patient also felt very lightheaded and blood pressure taken and elevated at 188/84. (20-25 mins after injection). Injection site did swell and got red after. Also had mild HA after arriving home but didn't last long & nauseous feeling the whole day after getting vaccine. Patient did not take any medications and all symptoms resolved on own.
64 2021-01-26 chills, headache VERTIGO, CHILLS, NAUSEA, HEADACHE, LEFT ARM ARM UP TO BASE OF SKULL
64 2021-01-27 fever, headache Fever, diarrhea. Vomiting, body aches, headache, back of neck aches, pain at site of shot
64 2021-01-27 respiratory tract congestion, headache H/A with nausea and dizziness, slight congestion. lasted 1/2 day
64 2021-01-27 throat pain I had a sore throat like it was inflamed and my lymph nodes were swollen. I went to Urgent Care in ... Read more
I had a sore throat like it was inflamed and my lymph nodes were swollen. I went to Urgent Care in about 2 weeks after the vaccine. The rapid strep test was NEG.
64 2021-01-27 fatigue Inflammatory pain; Little dizziness/Light headedness; Fatigue; Arthritis pain in hip, in hand and in... Read more
Inflammatory pain; Little dizziness/Light headedness; Fatigue; Arthritis pain in hip, in hand and in wrist; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer's COVID Vaccine; lot number: EL1284; expiration date: 30Apr2021), via an unspecified route of administration left upper arm on Jan2021 at a single dose for covid-19 immunization. Medical history included lupus. There were no concomitant medications. The patient reported that she got her first dose of the COVID Vaccine 2 weeks ago today (Jan2021), and this is her second dose next Saturday. She was a non-medicated, non-kind of remission level of lupus. She mentioned that she was okay the second day, she thinks. She had a little dizziness, fatigue and light headedness that kind of thing. But the top 3 or 4 days ago, so like on her 8th or 9th day, she started to get like inflammatory symptoms like arthritis pain in her hip, in her hand, in her wrist. It was also reported that the patient experienced inflammatory pain on an unspecified date. So, she was just wondering if there are any reports of people with lupus and if the other people have reported that. She mentioned that she wanted to get the second dose but was a little concerned if those arthritis symptoms are going to be worse. No treatment was received. The causality was reported as yes. The patient she hasn't gone visit any emergency room/ physician's office for the adverse events. The outcome of the events was unknown.
64 2021-01-27 malaise, fever, chills Low grade fever/fever; Chills; Body ache/whole body aches; Nausea/I am getting nauseated; Not feelin... Read more
Low grade fever/fever; Chills; Body ache/whole body aches; Nausea/I am getting nauseated; Not feeling well; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , via an unspecified route of administration on 13Jan2021 at a single dose as patient works in a Healthcare Facility, also under the recommendation of her physician (COVID-19 immunization). Medical history included cardiomyopathy and patient has pacemaker defibrillator. Concomitant medication included sotalol. The patient had the injection (patient described the product as Pfizer EL3246) yesterday, the first dose and about 2 o'clock this morning (14Jan2021) she woke up and have been having symptoms, the side effect symptoms, she had fever, the chills, the body ache, the nausea and just not feeling well at all. The patient was still experiencing the events. The patient stated that they are actually kind of getting worse, she was getting nauseated, her entire whole body aches, not feeling well at all, she had a fever, she just took temp of herself and she has a low grade fever. No treatment was administered for the events. The outcome of the events was not recovered. Information on lot number has been requested.
64 2021-01-27 fatigue, fever, chills body ache; Chills; Low fever; Fatigue; This is a spontaneous report from a contactable consumer (pat... Read more
body ache; Chills; Low fever; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown (as reported: "EK5230 or EK5730, it could 52 or 57, I am not sure, that may be 5730"), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. There were no medical history and concomitant medications. The patient reported some side effects from the COVID vaccine. The patient reported she had 3 days (as reported-pending clarification) of really bad body ache, chills, low fever, and fatigue from 14Jan2021. The patient received "Flu syrup" as treatment for the adverse events. The outcome of events was not recovered (as reported "still experiencing"-pending clarification). Information about lot/batch number has been requested.
64 2021-01-27 body temperature increased, headache patient developed a fever right after injection, went up to 103.5 overnight, called off work the fol... Read more
patient developed a fever right after injection, went up to 103.5 overnight, called off work the following day sick - headache and vomiting
64 2021-01-28 fever, throat pain, chills Fever, chills, body aches and sore throat. Treatment: Tylenol, Outcome: body aches, chills and fever... Read more
Fever, chills, body aches and sore throat. Treatment: Tylenol, Outcome: body aches, chills and fever improved, report of sore throat and not feeling 2 weeks later. Referred for testing.
64 2021-01-28 headache, cough, fever High heart rate, 125. high respiration, 110, severe coughing. They started IV OF SODIUM CHLORIDE... Read more
High heart rate, 125. high respiration, 110, severe coughing. They started IV OF SODIUM CHLORIDE, GAVE ME STERIODS, AND LORATIDINE, AND SOMETHING ELSE. WAS IN EMERGENCY FOR 4 HOURS. STILL COUGHING, HEADACHE, FEVER NOW 24 HOURS LATER
64 2021-01-28 fever Patient was found with AMS 1 day after receiving vaccine. Patient had pain at the injection site an... Read more
Patient was found with AMS 1 day after receiving vaccine. Patient had pain at the injection site and fever of 103.
64 2021-01-28 headache, fatigue, chills The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea. 48 hours l... Read more
The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea. 48 hours later your feeling much better. Took Tylenol and also Ibuprofen and stayed hydrated. Also had arm soreness, which she had with 1st vaccine as well.
64 2021-01-28 headache, fever headache, bone and muscle aches on left side (collar bone, shoulder blade, rib cage, neck, back), fe... Read more
headache, bone and muscle aches on left side (collar bone, shoulder blade, rib cage, neck, back), fever (99.5-100.5 for 1+ days), nausea (5+ days)
64 2021-01-29 fatigue, chills Chills, fatigue, heart flutters
64 2021-01-30 headache, fever, lethargy, chills Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like... Read more
Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like blue blazes, itched intensely, and I had a fever of 102.4. To get my temperature down to 100 degrees I had to alternate Motrin and Advil. I continued to have a fever, headache, body aches, chills, and lethargy for the next 48 hours and stayed in bed because I felt so awful. Unable to do normal activities of daily living.
64 2021-01-30 fever, chills Approximately 19 hours after my second Pfizer vaccine, I experienced dizziness, plus fever and chill... Read more
Approximately 19 hours after my second Pfizer vaccine, I experienced dizziness, plus fever and chills. I experienced two bouts of extreme dizziness, within minutes of each other. I did not go to the hospital nor did I call 911. My husband helped me to my bed where I went to bed and slept off and on for over two hours. I felt well enough to eat lunch, then went back to bed, where I slept for three hours. No more episodes of dizziness occurred.
64 2021-01-31 throat irritation Approx. 10 minutes after receiving vaccine, pt. reported an "itchy throat", following another 10 min... Read more
Approx. 10 minutes after receiving vaccine, pt. reported an "itchy throat", following another 10 minutes, approx. of "funny feeling in her throat". Then MD was paged in allergy, she talked with pt. and RN on speaker phone to assess patient. Two sets of vitals were taken, and pt. was administered another Zyrtec 10 mg. was given p.o. Pt. entire time was able to drink water and swallow. Pt. accompanied with a family member who can drive her home. Pt. stayed approx. 45 min, until all symptoms resolved. Other nurses in clinic made aware. MD instructed pt. that she would be contacted by allergy for further follow up prior to her second appointment for dose 2, and that patient was ok to come in for dose two. Pt. had epi pen with her at al times in her purse.
64 2021-01-31 chills, fatigue, headache Approximately 24 hours after COVID 19 vaccine administered, started with headache, body aches and ch... Read more
Approximately 24 hours after COVID 19 vaccine administered, started with headache, body aches and chills and fatigue. Occasional nausea but no vomiting. Lasted from 1/29/21 to 2/1/21.
64 2021-01-31 lethargy, fever Fever spike 102.1, lethargy, refusal to eat, drink and take medication; sent to ER on 1/30/21; COV... Read more
Fever spike 102.1, lethargy, refusal to eat, drink and take medication; sent to ER on 1/30/21; COVID tested (negative) returned home same day.
64 2021-01-31 fatigue, headache, fever Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am tha... Read more
Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am that morning. Intense fatigue and moderate headache. I had joint and body aches. I experienced lightheadedness when I got up when fever was 101.8 at 2:30 pm. I had to lay down again and apply a wet towel. Once I felt able to walk (about 10 minutes later) I ate a popsicle and then proceeded to take two 325 mg of Tylenol. Within 30 to 45 minutes fever subsided. I then ate soup, crackers and an orange and drank cranapple juice. I went back to bed and slept some more. I woke up at 5 pm and had a cup of soup, a quarter of an apple and gatorade. At 9 pm I took two more Tylenol to be safe and when to sleep. Sunday I was fine. My arm, never was swollen only a little sore.
64 2021-01-31 headache, malaise, fever Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a sponta... Read more
Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a spontaneous report from a contactable consumer reporting for herself. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration, on 11Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient reported that she received her COVID Vaccine on Monday afternoon 11Jan2021. The patient experienced events doesn't feel good and her arm is sore on an unspecified date in Jan2021. On 11Jan2021, after she got the shot, an hour after she started getting nauseous. On Tuesday, 12Jan2021, she experienced headache that went away the next day. On 13Jan2021, her muscles started to ache. That lasted on Wednesday (13Jan2021), Thursday (14Jan2021). On Friday (15Jan2021) afternoon, when she got home from work, she started running a fever and at the time of report she was still running a fever. She stated, "as of right now starting yesterday afternoon, I've got my fever, I don't feel good, I ache, my arm is sore but that's okay. It started Monday afternoon after I got the shot, an hour after I started getting nauseous that was Monday afternoon. Tuesday, I got headache that went away on Wednesday. On Wednesday my muscles started to ache. And that was Wednesday, Thursday and Friday afternoon when I got home from work, I started running a fever and I am still running a fever." When confirmed if the consumer wanted to report the same or looking for some information, consumer stated, "I want to report this and I just want information, what do I do? I test twice a week, rapid test and saliva test for COVID. And I have tested negative for months. And I tested negative before I got the vaccination, I tested on Thursday (14Jan2021), I am still negative. That was the rapid test." The patient took ibuprofen as a corrective treatment for the reported adverse events. Outcome of the event headache was recovered on 13Jan2021, outcome of fever was not recovered, while outcome of the other events was unknown. Information on the lot/batch number has been requested.
64 2021-01-31 fever, headache Patient received 2nd COVID vaccine on 1.28.2021. Patient states she experienced fever, vomiting, he... Read more
Patient received 2nd COVID vaccine on 1.28.2021. Patient states she experienced fever, vomiting, headache, and body aches beginning a few hours after receiving the second vaccine. Patient states all side effects except for the fever have resolved as of this morning. Patient also reports that she began having hallucinations this morning (2/1). She says she is seeing spiders all over her home. Put the patient on hold and reached out to family practice staff. Patient states that hospice nurse is coming at 1:30pm today. I told the patient about informing her PCP due to the hallucinations. The patient does not voice any other complaints. Instructed the patient to seek emergency care for severe/concerning symptoms
64 2021-01-31 headache, fatigue, chills Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever ... Read more
Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever of 99, fatigue, pronounced pain in arm and shoulders
64 2021-02-01 headache, fever, chills Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; N... Read more
Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; Nausea; She felt like she had a temperature and by the time it was checked her temperature was 101.9/febrile; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left upper arm on 07Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, not a Military Facility. The patient's medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient received the first dose of BNT162B2 (lot number: EK57530), via an unspecified route of administration at left Upper arm on 17Dec2020 9:10AM for covid-19 immunization. She only had a sore arm. It started the same day, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. She got the second dose on 07Jan2021. After the second dose, immediately, like within five minutes her arm became very sore, this event was assessed as non-serious by HCP. Also, that Thursday (07Jan2021) night after getting the second dose of the Vaccine around 9PM-10PM she started to get chills, myalgia, severe headache, and nausea. She also mentioned she was so sick during the night she was not able to get up and around. She felt like she had a temperature and by the time it was checked her temperature was 101.9. She was febrile all through 08Jan2021. She started to become afebrile 09Jan2021 with improvement and by 10Jan2021 all her symptoms had gone away and completely resolved. Seriousness Criteria: Stated she felt these are serious. She was unable to go to work on Friday. She could not return back to work until Monday. The HCP assessed all events were related to the vaccine. The outcome of the events was recovered on 10Jan2021. She stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.; Sender's Comments: Based on plausible temporal relationship, clinical course and known safety profile of the product, the reported events chills, myalgia, severe headache, nausea and fever were likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
64 2021-02-02 fever, fatigue faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a sponta... Read more
faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a spontaneous report from a contactable physician (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3426, expiration date: unknown), via an unspecified route of administration on the left arm on 16Jan2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included cardiac hypertrophic cardiomyopathy. The patient has no known allergies. Concomitant medications were not reported. No other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 24Dec2020 at the age of 64 years old, lot number: Ek9231. On 16Jan2021 at 11:00 PM, the patient experienced faintness, fevers at 101.5 and 102.7 (on day 3), myalgia, fatigue, tracheitis for 3.5 days- stopped around 4AM on Wednesday, and respiration rate of 40. The patient has no COVID prior vaccination and has not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.5 on 16Jan2021, heart rate (HR): 80 on 16Jan2021, respiration: 40 on 16Jan2021 and body temperature: 102.7 on 20Jan2021. No treatment was administered for the events. The patient recovered from the event tracheitis on 20Jan2021 at 04:00 while recovering from the rest of the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Faint cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-02-03 headache, fatigue, chills Shortly after the vaccination I developed a really bad headache for the first 2 days. Stopped for a... Read more
Shortly after the vaccination I developed a really bad headache for the first 2 days. Stopped for a day and returned for another day and went away on its own. I had inside body chills, felt weak and tired and had a little sinus pressure but no fever which lasted for about 2 or 3 days. I took aspirin to help with the discomfort and today I still have just a little nagging headache that comes and goes but all other symptoms has since subsided. The injection site swole and developed a knot which stayed about a week and is still a little red.
64 2021-02-03 headache, chills, fever fever; chills; headache; extreme bodyaches; This is a spontaneous report from a contactable nurse re... Read more
fever; chills; headache; extreme bodyaches; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Jan2021 at 12:30 PM (at the age of 64 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included anemia, hemachromatosis, and penicillin allergy. The patient previously received the first dose of BNT162B2 on 29Dec2020 at 12:15 PM (at the age of 64 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Concomitant medication included epoetin alfa (PROCRIT) and deferasirox (JADENU). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:00 PM, the patient experienced fever, chills, headache, and extreme bodyaches. The patient did not receive any treatment for these events. The outcome of the events fever, chills, headache, and extreme bodyaches was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
64 2021-02-03 fatigue, runny nose more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; Th... Read more
more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine), intramuscularly on 15Jan2021 at single dose into the left arm for COVID-19 prophylaxis. Medical history included asthma; blood pressure abnormal (she takes blood pressure medication); palpitations at times; having mild chest discomfort, had experienced this before, that she was attributing to her wearing a mask, she wore 2-3 masks; stated that she had Covid once and she did not want it again. Concomitant medications included some blood pressure medication, and salbutamol (ALBUTEROL) inhaler periodically. Caller is a LPN nurse that was calling about the Covid-19 vaccine and reported that she received it Friday 15Jan2021 and just wanted to report some mild side effects. Caller clarified that she was more tired, had weakness, had diarrhea for 2 days, increased heart rate, and a runny nose, soreness at the injection site . She stated that she was not in a lot of distress. More tired started from 17Jan2021 and soreness at the injection site started from 16Jan2021. Weakness started from 17Jan2021: She stated that went home straight from work and went to the couch and slept about 6 hours. She had been up since 0300 and it was almost 1200 now. She stated that her energy level and weakness was pretty good right now. Diarrhea started from 16Jan2021: She said that she had the urgency to go and it was definitely soft and foul like when you had the flu. She stated that she has had it once since this morning. It was semisolid. Increased heart rate started from 17Jan2021: she felt palpitations at times. She said that she did not know if they were related, but stated that they were aggravating yesterday. She stated that she took blood pressure medication. She stated that she used a inhaler albuterol. She was using her inhaler periodically and said that it could be because of the albuterol inhaler. Runny nose started from 15Jan2021: Runny nose started about 8-10 hours after her injection. Stated that it was not bad, she would just have to blow her nose really good every so often. She said that she has not had to blow her nose today since she had been up. She said that the vaccine was sitting on the table and they just told her it was the Pfizer BioNTech vaccine. She did not have her vaccination card with her at the time of the call. The patient had recovered from weakness on 18Jan2021, recovered from increased heart rate and soreness at the injection site on 17Jan2021; she was recovering from more tired, runny nose, and she had not recovered from diarrhea. Reporter seriousness for increased heart rate, runny nose and soreness at the injection site was not serious. The reporter (nurse) considered the events more tired, weakness, diarrhea, runny nose and soreness at the injection site were related to bnt162b2, and relatedness of bnt162b2 to reaction increased heart rate was unknown. Information on the lot/ batch number has been requested.
64 2021-02-04 throat irritation, headache 20 mins. after injection itching of face and gradual body. approx. 1 hour throat itching, approx. 4 ... Read more
20 mins. after injection itching of face and gradual body. approx. 1 hour throat itching, approx. 4 hours mild headache, some rash only on neck and chest but within less than 8 hours full body rash, some milder aches but NEXT morning horrible pain all over like I had been thrown into my worst ever fibromyalgia flair. Complete muscle, joint, entire deep body. WORST i ever had. then a few welps and even though 90% was under the skin rash husband and I could feel the 10 % was red, small pimple like IF not the neck welps and then on the 4 day had a few hives on face only. Worst itching I have ever had and I have had chicken pox and antibiotic rashes. I think the problem has been came off of antibiotic and gradually got ok but can not get this out of system so easy of course. Today is 1 week. rash is better but not gone and itching is some better but still not good. I did not take benadryl or anything since I DO NOT want to interfere with me getting as much benefit from the injection since I now can not have number 2.
64 2021-02-04 fever, headache Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injecti... Read more
Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injection site red the size of a quarter, hot and sore to the touch and hard. Arm aches into shoulder.
64 2021-02-04 chills, headache, fatigue Headache; body aches; joint pain; chills; fatigue; This is a spontaneous report from a contactable n... Read more
Headache; body aches; joint pain; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el0142), via an unspecified route of administration on left arm on 20Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medication included solifenacin succinate (VESICARE), dl-alpha tocopheryl acetate (VITAMIN E), omeprazole and Multivitamin. The patient previously received her firs dose of BNT162B2 at 11:00 AM on 02Jan2021 intramuscularly on left arm for Covid-19 immunization. The patient experienced headache, body aches, joint pain, chills and fatigue on 21Jan2021 05:00 AM. The events were reported as non-serious. The patient did not receive any treatment from events. The outcome of events was not recovered.
64 2021-02-04 headache Nausea, vomiting , headache, body ache
64 2021-02-04 fatigue Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contacta... Read more
Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3249), via an unspecified route of administration on the right arm on 22Jan2021 08:45 am at single dose for COVID-19 immunisation. Medical history included hyperthyroidism, BP elevation, hyperlipidaemia and allergies to chocolate, coconuts, pineapple, and red dye from an unknown date. Patient previously took codeine, statins, Diflucan, and experienced allergies. Concomitant medication included methimazole, dexlansoprazole (DEXILANT), amlodipine, ezetimibe (ZETIA), evolocumab (REPATHA) from unspecified date and indication. On 22Jan2021 at 08:45 pm, it was reported that the patient experienced pain in the arm of the injection, muscle pain, and fatigue. No treatment was received. The events were considered as non-serious and did not resulted in death, life threatening condition, prolonged hospitalization, disability, and congenital anomaly or birth defect. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since vaccination. No other vaccines were received within the last 4 weeks prior to receiving the COVID-19 vaccination. The patient was reported to be not pregnant at the time of vaccination. The outcome of the events were not recovered.
64 2021-02-04 fatigue, headache Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tirednes... Read more
Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tiredness & fatigue, foggy brained, extreme body aches and pain, unable to walk from weakness, nausea, excruciating headaches, irregualar heartbeat, nausea. Reddness and swelling in arm for over 1wk. Nausea about 10 days.
64 2021-02-04 chills, fever WAS TOLD THAT MY ARM WOULD BE MORE SORE AFTER THIS SECOND SHOT BECAUSE i CHOSE TO GET IT IN THE SAME... Read more
WAS TOLD THAT MY ARM WOULD BE MORE SORE AFTER THIS SECOND SHOT BECAUSE i CHOSE TO GET IT IN THE SAME ARM AS THE 1ST DOSE. WHILE I DIDNT FEEL THAT SORE IN MY SHOULDER on 2/3 THE FOLLOWING DAY AFTER A HIGH FEVER AND GENERAL/ALL OVER MUSCLE ACHE, CHILLS my left armpit began to hurt like I'd pinched or been punched in it, today my armpit is swollen with a knot under the skin and very sore to the touch and slightest movement (injection site is red and swollen with a knot in that area as well. *my son also received his second shot on same day & he is reporting to me the exact same issue.* icing the area is not helping.
64 2021-02-04 fever, chills razor sharp pain at injection site delirious with fever chills whitening of skin lasting 5 hours
64 2021-02-05 headache Dizzy Heart Palpitations Shortness of Breath Tingling of Lips & Tongue Swollen Face Head Pain Throa... Read more
Dizzy Heart Palpitations Shortness of Breath Tingling of Lips & Tongue Swollen Face Head Pain Throat Tightness
64 2021-02-06 headache, fatigue, chills Chills, headache, extreme fatigue
64 2021-02-07 chills, fatigue, headache shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pai... Read more
shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pain; joint pain; fatigue; This is a spontaneous report from a contactable nurse (patient herself). A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular (left arm), on 20Jan2021 09:00, at single dose, for covid-19 immunization. Medical history included allergies: penicillin, sulfa, environmental. Concomitant medications included levothyroxine; cetirizine hydrochloride (ZYRTEC ALLERGY); calcium; and colecalciferol (VIT D3). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), on 30Dec2020 16:00, intramuscular (left arm), for covid-19 immunization at 64-years-old. The patient experienced, "10-11 hr" post injection, on 20Jan2021 20:00 started shaking chills lasting 10 hours. The patient also experienced on 20Jan2021 20:00 severe frontal headache with nausea and intermittent dizziness, muscle pain, joint pain, and fatigue - which all resolved after about 24 hr after onset. No treatment was received for these adverse events. The patient recovered from all the events on 21Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination and have not been COVID tested post vaccination.
64 2021-02-16 pneumonia Patient developed pneumonia Admitted to hospital on 12/25. Determined to have pseudomonas bacteremia... Read more
Patient developed pneumonia Admitted to hospital on 12/25. Determined to have pseudomonas bacteremia and passed away on 12/27.
64 2021-02-16 cough Right after the vaccine was administered, started with a cough that did not improve for the next few... Read more
Right after the vaccine was administered, started with a cough that did not improve for the next few minutes. Needed respiratory therapy
64 2021-02-17 throat irritation Swollen and blistered lips; Swollen and blistered lips; Itching inside my mouth and throat, and on m... Read more
Swollen and blistered lips; Swollen and blistered lips; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date was not reported) given at 64 years of age, via an unspecified route of administration in the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included known allergies. Concomitant medication included thyroid (ARMOUR THYROID), aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), and metronidazole. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested for COVID-19 since the vaccination. It was reported that less than one hour after receiving the vaccine on 25Jan2021 at 04:00 PM, the patient developed itching inside her mouth and throat, and on her hands and legs. The itching stopped with BENADRYL. Four days later on 29Jan2021 14:30, she developed swollen and blistered lips. The outcome of the events was recovering and were reported non-serious. Treatment received for the events included steroid injection five days after the vaccine. The events resulted to doctor or other healthcare professional office/clinic visit then emergency room/department or urgent care.
64 2021-02-21 headache Patient complained of stiffness/right side; headache, dizziness after receiving first dose of Pfizer... Read more
Patient complained of stiffness/right side; headache, dizziness after receiving first dose of Pfizer; Comprehensive nursing assessment done including vital signs, pain, neurological status. Patient stated she had no difficulty swallowing. She was given water. Vital signs remained stable.
64 2021-02-22 fatigue, fever, chills Fatigue, muscle aches, chills, fever, nausea, diahrea, vomiting
64 2021-02-22 headache I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt d... Read more
I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt dizzy nausea and wanted to vomit. Then I passed out, I fell down and hit my face on the floor. My family called 911 paramedica. They ,measured d my blood pressure and it was too low. The area around my right eyebrow was swollen and my neck hurt as precaution I went to the hospital. I suspect the incident and its symptom are side effects of the vaccine given the timing. Later on I had headache off and on and brain fog.
64 2021-02-22 fatigue, influenza like illness, fever vaccine 1/6, flu like symptons (achy, fever, tires) 1/7-1/8, low grade temp 1/9-1/10, felt fine 1/11... Read more
vaccine 1/6, flu like symptons (achy, fever, tires) 1/7-1/8, low grade temp 1/9-1/10, felt fine 1/11, achy, fever, tired 1/12-1/14, got covid test to double check, negative
64 2021-02-23 headache, fatigue For 8 days: heavy fatigue, headache, For 3 days: rash For 5 days: nausea
64 2021-02-23 fatigue, headache Headache 48 hours Fatigue 48 hours
64 2021-02-23 headache, malaise Psoriasis came back all over my body. Psoriasis on hands for the first time! Extreme burning on sk... Read more
Psoriasis came back all over my body. Psoriasis on hands for the first time! Extreme burning on skin lesions. Headache, weak, overall feeling sick. I had Covid over thanksgiving 2020. I still had antibodies when I got my Covid vaccine.
64 2021-02-23 fatigue arm was very black and blue where the shot was administered and way around it/severe black and blue ... Read more
arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; yeast infection from it; incredible arm pain/arm was really hurting bad; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 12:00 at a single dose on the arm for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she was fine but on 23Jan2021 at 16:00, she experienced an incredible arm pain and fatigue. Her arm was really hurting bad. On 25Jan2021, the patient stated that her arm was very black and blue where the shot was administered and way around it. There was a severe black and blue mark and bump like a golf ball on the arm where she got vaccinated and had yeast infection from it. She never had this before since she never had a vaccine when she was a little kid. She wanted to know if they have heard about this before. She wanted to know if this was normal and if she needs go to the doctor. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient can't get appointment for second shot. The patient was not pregnant at the time of vaccination. The outcome of the events incredible arm pain and fatigue was recovering while the other events was not recovered.
64 2021-02-24 throat irritation Itchy throat, rash around the mouth. Patient cleared by EMS
64 2021-02-24 influenza like illness, headache Pfizer Was the manufacturer 24 hours after receiving the vaccine, I started having headaches follow... Read more
Pfizer Was the manufacturer 24 hours after receiving the vaccine, I started having headaches followed by illness that remined me somewhat of getting the flu. Also, very tired and lack of appetite.
64 2021-02-25 fatigue Normal arm soreness, very achy, tiredness
64 2021-02-25 fatigue, throat pain Patient started having tingling in her lips 5 days after the injection, then she began having a sore... Read more
Patient started having tingling in her lips 5 days after the injection, then she began having a sore throat, she started having a hoarse voice and she felt very tired. 911 was called. In route they were transporting patient she was hypertensive had normal heart rate they gave her Benadryl 50 mg orally and then epinephrine 0.3 mg IM which did not help patient at all.
64 2021-02-25 fever RASH, DYSPNEA, CHEST PAIN, FEVER JOINT PAIN, CHILLS, FEVER. TREATMENT: KENALOG, BENADRYL, PEPCID.
64 2021-02-26 head discomfort Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to it... Read more
Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to itch a little. A little itching around eyes. About an hour after, felt tightness in my throat and neck, glands felt swollen. Became slightly hoarse, had to clear my throat often. Felt a little like asthma attack. Have had similar reaction when eating seafood
64 2021-02-27 fever, fatigue, headache Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; ... Read more
Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; exhaustion 2/26 extreme fatigue; 2/27 extreme fatigue; nausea; diarrhea; headache
64 2021-02-27 fatigue, headache, malaise TIRENESS, HEADACHES, NAUSEA, FELLING UNWELL, SOME ON AND OFF DIZZENESS.
64 2021-02-28 fatigue, chills, headache Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; ... Read more
Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL 8982, expiry date: not reported), via an unspecified route of administration, on 26Jan2021 12:15 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine in four weeks prior to receiving bnt162b2. The patient was not pregnant. She was not diagnosed with covid prior to vaccination. Medical history included high bp (blood pressure) and type 2 diabetes. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL 1284, expiry date: not reported), on 05Jan2021 10:30 AM on the right arm for COVID-19 immunization (at the age of 64-year-old). On 26Jan2021 04:30 PM, the patient experienced chills, headache, muscle and joint pain, tiredness, nausea; like a mild flu. No treatment was received for the events. Outcome of the events was recovering. The patient was not tested for covid post vaccination. No follow up attempts are possible. No further information is expected.
64 2021-02-28 fatigue, headache Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spo... Read more
Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at arm left on 09Feb2021 at 14:10 (at the age of 64 years) at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease, ongoing allergies, ongoing blood cholesterol abnormal. Concomitant medication included mesalamine (strength: 400 mg) oral at 400 mg twice daily for Crohn's disease, atorvastatin oral at 400 mg once a day for blood cholesterol abnormal, azathioprine oral at 50 mg twice daily for Crohn's disease, cetirizine oral at 10 mg for allergies, vitamin D at 1000 iU daily for supplementation, ketotifen fumarate (strength: 0.025 %) ophthalmic twice daily for allergies and ipratropium bromide (strength: 0.06%) nasal daily for allergies, all from an unknown date and ongoing. The patient experienced sore at the injection site on 09Feb2021, headache on the left side and her left arm was hurting from the shoulder down and she feels really tired and nauseous, all on 12Feb2021. The patient outcome of injection site pain was recovered on 09Feb2021; the outcome of the other events was not recovered. The information on the batch number has been requested.
64 2021-02-28 headache Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next ... Read more
Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next morning. No medication taken. Moderate headache lasting through next morning, general grumpiness for 2 days, brain fog beginning following morning - forgetfulness, depression. Still continued through today (Monday, March 1, 2021). Symptoms are not severe, but are acute enough that they are impacting quality of life.
64 2021-02-28 sweating Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, an... Read more
Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, and then completely down for a couple of hours, ending by day 3. Have been constipated for five days now, with no bowel movement since vaccine. I have had extreme insomnia since vaccine.
64 2021-03-02 cough, nasal congestion 12Jan was the first dose of the covid vaccine, 18Jan she had a positive covid test; Congestion; Coug... Read more
12Jan was the first dose of the covid vaccine, 18Jan she had a positive covid test; Congestion; Cough; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 64-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her right arm, via an unspecified route of administration on 12Jan2021 08:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient started to feel symptoms on 16Jan2021 09:00, which is cough and congestion. On 18Jan2021, she tested positive for COVID. She is scheduled for getting her second dose on 09Feb2021. She is calling to question if she should get the second dose since she was diagnosed with COVID. The outcome of the events was unknown.
64 2021-03-02 headache Patient taken to ED by EMS after COVID vaccine. Patient with SOB, dizziness, and HA after first COVI... Read more
Patient taken to ED by EMS after COVID vaccine. Patient with SOB, dizziness, and HA after first COVID vaccine.
64 2021-03-02 headache, fatigue mild headache; tiredness; bruised arm not at injection site; This is a spontaneous report from a con... Read more
mild headache; tiredness; bruised arm not at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 64 -year-old female (not pregnant at time of vaccination) patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ek9231), via an unspecified route of administration (on the left arm) on 07Jan2021 14:30 (at the age of 64-years-old), single dose for COVID-19 immunization. Relevant medical history included Allergies, mvp, hbp, thalassemia all from an unknown date. The patient's concomitant medication was not reported. The patient experienced mild headache, tiredness and bruised arm not at injection site, all from an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test on 10Jan2020, 15May2020 and 01Oct2020, all negative. Patient has no other vaccine in four weeks. No covid prior to vaccination. No treatment received for the adverse events. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021143321 same reporter/patient/drug, different events separated with time
64 2021-03-02 fever, headache sore arm; mild headache; slight fever; swollen painful axillary lymph nodes; swollen painful axillar... Read more
sore arm; mild headache; slight fever; swollen painful axillary lymph nodes; swollen painful axillary lymph nodes; This is a spontaneous report from a contactable healthcare professional. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at the age of 64 years, via an unspecified route of administration on the left arm on 28Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included allergies, MVP (Mitral valve prolapse), HBP (High blood pressure) and thalassemia. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously received the first dose of BNT162B2 on 07Jan2021 (age at vaccination: 64 years), lot number: Ek9231 and experienced mild headache tiredness bruised arm not at injection site. On 29Jan2021, the patient experienced mild headache, slight fever and swollen painful axillary lymph nodes. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, COVID test: negative on 15May2020 and nasal swab: negative on 01Oct2020. The outcome of the events was not recovered.
64 2021-03-02 fatigue very ill; very bad stomach issues; felt like someone was stabbing; couldn't eat/hadn't eaten for a c... Read more
very ill; very bad stomach issues; felt like someone was stabbing; couldn't eat/hadn't eaten for a couple of days; every time food reached her stomach, it was a horrible pain; fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3284, NDC number and expiration date were unknown), intramuscularly in the left arm on 25Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the nursing home. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL0140, expiry date was unknown), on 04Jan2021 intramuscularly in the left arm for COVID-19 immunization. Relevant medical history included problems in blood pressure and sleep and restless leg syndrome; pain in legs; all from an unknown date and unknown if ongoing. Concomitant medications included amlodipine for blood pressure, gabapentin for restless leg syndrome; pain in legs, venlafaxine for antidepressant therapy, bupropion (also reported as the generic for Wellbutrin) for antidepressant therapy, and chlordiazepoxide to help sleep; all medications were ongoing. There were no additional vaccines administered on the same date of the Pfizer suspect. The patient had no prior vaccinations within 4 weeks. The patient worked at a nursing facility, but she was not a healthcare professional. After receiving the first vaccine, she felt great. The vaccine built her immunity up, which was good. With the second vaccine, she got very ill over it on an unspecified date. The patient was asking if there had been other people reporting side effects of the vaccine. The patient further reported that after she was given the second vaccine, they had a waiting time where she had to sit and wait about 15 minutes and it was fine. After work on an unspecified date, she had gone to pick up some groceries and it hit her like a ton of bricks. It was really, really bad. When she was given the vaccine, she asked the pharmacist from the time she was given the vaccine, if there would be any special time she would have symptoms or experience what would be going on. The pharmacist told her everyone was different, but that she would definitely know. The patient stated she had very bad stomach issues; it felt like someone was stabbing her on an unspecified date. She had no vomiting or diarrhea, but when she ate, it was horrible. She couldn't eat; every time food reached her stomach, it was a horrible pain. She also experienced some fatigue on an unspecified date. She got tired a lot. She had to call her employer and tell them that she wouldn't be coming in. This went on for a week. She still had some side effects, but its working its way out of her and she could tell. The patient stated she didn't believe her employer believed her. She had called and left messages and it went no where. She was afraid and she didn't want to lose her job. The patient stated that she really hadn't eaten for a couple of days at the time of the report. She asked one of the nurses where she worked if she should be drinking water and continue to try and eat and the nurse told her to drink as much water as she could and rest her body. The patient didn't believe her employer believed that this was actually happening to her. The patient was very upset that she could lose her job and she didn't know what to do or who else to call. The patient explained that mentally, she was feeling better, but her body hadn't caught up with her mind. The patient stated she needed any information to show that she spoke with Pfizer that she could give her employer. The adverse events (AEs) did not require any visit to an emergency room or the physician office. The patient had no investigation assessment and relevant tests. The outcome of all the events was unknown.
64 2021-03-03 throat pain Tightness in left bicep (front—not where shot administered) and forearm and tingling in hand (left ... Read more
Tightness in left bicep (front—not where shot administered) and forearm and tingling in hand (left side where shot administered. Tightness has dissipated somewhat, but tingling in hand continues to be present Sore throat right after administration Extremely sore arm for 2 days after administration
64 2021-03-03 malaise, headache, throat pain skin is burning up, her arms, her face, her stomach, her back, and her chest are burning up/burning ... Read more
skin is burning up, her arms, her face, her stomach, her back, and her chest are burning up/burning skin has probably gotten worse; Nausea; no appetite; Headache; bad sore throat; felt sick since she got it; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL9262), via an unspecified route of administration on left arm (at the age of 64 years) on 24Jan2021 at single dose for covid-19 immunization. Medical history included type 2 diabetes (borderline about 15 years ago/started taking a medication a year ago for her high sugar numbers/had some blood tests, her A1C was normal, her diabetes was the same way it always has been); hypertension from 2012 (diagnosed about 9 years ago); sleep apnea from 2020 (uses a C-PAP machine/diagnosed approximately a year ago); Epstein Barr from 1995 (diagnosed when she was 39); high cholesterol (sometimes she didn't take her medication for that); cataract and cataract surgery in Jan2021 (had this last month/they used anesthesia/didn't know which type/had some eye drops for this). Concomitant medication included an unspecified high blood pressure medication (she thinks she tried a few times). The patient called about Pfizer COVID-19 vaccine and she had questions and side effects. She did get one shot, and was not due for her second for a couple weeks. The patient felt sick since she got it, some side effects have been less, some stayed the same or got worse. Her skin was burning up, her arms, her face, her stomach, her back, and her chest were burning up. She has done no treatment, because she didn't know what to do to treat it and it was difficult to be able to get in to see a doctor. The burning skin has probably gotten worse. She also had nausea and no appetite, though she has gotten a little better, it has been at least a full week or so. She had a headache and a bad sore throat also. She got home from getting the shot, probably maybe 5 or 6 hours after getting the shot. The patient's weight was 145-150lbs. The outcome of the event skin burning sensation was not recovered while for the remaining events was unknown.
64 2021-03-04 fatigue, chills I had severe COVID and was hospitalized on Dec 7, I was in hospital (non ICU setting) for 5 days an... Read more
I had severe COVID and was hospitalized on Dec 7, I was in hospital (non ICU setting) for 5 days and had O2, remdisiver and dethemethzone IV. I recovered fully, and have felt very good since mid January. My reaction after my 1st dose of vaccine on Feb 25 started 20 hours after shot. Worsened through the day and I got sicker at 24-36 hours, and then stayed in bed another day. Symptoms were identical to my bout with COVID: chills (no fever), nausea, aches in joints and muscles, fatigue. They were quite significant==I could not be out of bed. As it went along I also developed the feeling in my chest like COVID--tough to take deep breath, chest hurt---but my O2 readings were fine. Recovered after 48 hours, People who have had COVID should be aware that they will have a significant response to the vaccine on the 1st does. I am questioning having a second dose I have not reported this to my doctor
64 2021-03-04 fatigue Nausea, vomiting, pain under breastbone , tired unable to eat, has stayed in bed basically from the... Read more
Nausea, vomiting, pain under breastbone , tired unable to eat, has stayed in bed basically from the evening of 02/25/2021 through 03/05/2021.
64 2021-03-04 cough Residents was previously positive for Covid-19 on 6/17/20. She received both doses of the Pfizer va... Read more
Residents was previously positive for Covid-19 on 6/17/20. She received both doses of the Pfizer vaccine. She tested positive again for Covid-19 on 2/10/21.
64 2021-03-07 headache, chills, malaise, fatigue My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling u... Read more
My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling unwell difficulty breathing a fast heartbeat weakness
64 2021-03-10 throat pain, chills Patient is a 64 y.o. female admitted for acute DKA, glucose is 771 Severe ketoacidosis, bicarb is o... Read more
Patient is a 64 y.o. female admitted for acute DKA, glucose is 771 Severe ketoacidosis, bicarb is only 7 AKI, pseudohyponatremia K 5.3 LFT's ok Got the covid 19 vaccine 2 days ago She has sore throat and chills She did vomit up coffee ground material
64 2021-03-11 fever, sweating, chills, headache, cough Shortness of breath, chest pain. coughing, diffuse headache and some body aches, fever, chills, swea... Read more
Shortness of breath, chest pain. coughing, diffuse headache and some body aches, fever, chills, sweats. increased work of breathing, tachycardic, tachypnic,
64 2021-03-14 chills, dehydration, fatigue, sweating, fever dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhe... Read more
dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhea; Super tired and went to bed by 8pm after COVID-19 vaccine; Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not receive any other vaccine the same day and in four weeks. Patient did not have COVID-19 prior to vaccination. The patient experienced passed out in floor (medically significant) on 24Feb2021 at 10:30 PM, diarrhea (disability) on 24Feb2021, broke a tooth (medically significant) on 24Feb2021 at 10:30 PM, dehydration (disability) on 25Feb2021 12:00 AM, slight fever (99) (disability) on 25Feb2021 at 12:00 AM, chills (disability) on 24Feb2021 at 10:30 PM, super tired and went to bed by 08:00 PM after COVID-19 vaccine (non-serious) on 24Feb2021, arm was sore (non-serious) on 24Feb2021, sweating (non-serious) on 24Feb2021 at 10:30 PM, dizzy (non-serious) on 24Feb2021. No therapeutic measures were taken as a result of the events. Patient stated that all side effects resolved completely by 25Feb2021 evening, except for broke a tooth. Patient did not tested positive for COVID-19 post vaccination. The information on the Lot/Batch number has been requested.
64 2021-03-14 headache had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned brig... Read more
had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned bright red Subsided within hour.; Ate supper, Went to bed, upon waking in nite experienced imbalance; vertigo; Neck pain; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264, Solution for injection), via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 vaccination. Medical history included CAD (coronary artery disease), Irregular heart rhythm, BPPV, degenerative disc disease, anxiety, ptsd (post-traumatic stress disorder), pre diabetic, Allergies to food, chemical and sensitivities and med and sensitivites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. Upon receiving injection, on 30Jan2021, patient had flush feeling (much like injection during CT scan). Within hour her ears felt hot and turned bright red Subsided within hour. After supper, went to bed, upon waking in night experienced imbalance. Laying back down experieced vertigo (what she thought was a BPPV episode, a prior cond) but she couldnt figure out which side to treat, she performed maneuver. But did not resolve. She was remaining off balance and spinny even being upright with movement of head or eyes. Neck pain and headache residual nausea. About 12 hours after injection. Upside, her arm doesnt hurt. The patient did not receive any treatment for the events. No seriousness criteria was reported. The patient underwent lab tests and procedures which included computerised tomogram and results are unknown. The outcome of events was unknown.
64 2021-03-15 pneumonia, headache Admitted to hospital- Acute severe progressive hypoxic respiratory failure- intubated, trach placed,... Read more
Admitted to hospital- Acute severe progressive hypoxic respiratory failure- intubated, trach placed, COVID-19 pneumonia, Afib Patient treated at primary care office 01/13/2021 for respiratory illness (tested negative for COVID at this time), had vaccine 01/20/2021, developed headache and tested positive COVID-19 the following day 01/21/2021. Symptoms worsened with nausea and shortness of breath. Patient admitted 01/29/2021, condition progressed- intubated 02/07/2021, trach placed 02/25/2021.Discharged to specialty hospital 03/12/2021 for continued respiratory support and rehabilitation
64 2021-03-15 fever, headache Beginning February 28, 2021 stroke, seizure, fever, headache and weakness.
64 2021-03-15 headache persistent headache; This is a spontaneous report from a contactable 64-year-old female consumer rep... Read more
persistent headache; This is a spontaneous report from a contactable 64-year-old female consumer reported that. A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3Z47), via an unspecified route of administration in the left arm, on 11Feb2021 09:00 AM, SINGLE DOSE for covid-19 immunisation. Medical history was none. The patient's concomitant medications were unknown. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not received treatment. The patient was not pregnant at the time of vaccination. On Feb2021 at 6:00 PM, the patient experienced persistent headache. Outcome of the event was recovering.
64 2021-03-18 fever, malaise, fatigue, chills, headache Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little... Read more
Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little fatigue; Severe arm/injection site pain; Severe arm/injection site pain/very sore arm; Chills; Low grade fever; Headache; Lightheaded; Weakness/really weak; Itchy rash on chest/has a rash on her chest/little rash on my back; Nausea; Loss of appetite; She is flushed; tested positive for Covid and 6 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: EL9265) in right arm via an unspecified route of administration on 08Feb2021 07:45 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included osteoporosis, Inappropriate sinus tachycardia, known allergies. Concomitant medication included estradiol benzoate (ESTRADIOL [ESTRADIOL BENZOATE]), calcium (CALCIUM), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), naproxen (NAPROXEN), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all at once a day. The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient had the first vaccine on 08Feb (complete date not clarified), two days after that it had most of the side effects, with the one very sore arm, headache, fever chills, nausea, feeling very tired, about 6 days after that she tested positive for Covid and 6 days after the first vaccine. She tested positive for Covid so for the last couple of weeks. She had Covid, the fever broke about 5 to 6 days ago, she had a low grade fever after that, also the symptoms were gone now, there was little fatigue and little rash on back. She was scheduled to take second shot now and was trying to find in research about taking the second shot inspite of having covid. She cant find anything, most of the people never heard this and primary care physician said to go ahead and take the shot, but some people and some researchers said you should not, because she might have symptoms later and she should wait. The treatment was not received for the adverse events. Outcome of tested positive for Covid and 6 days was unknown and for other events it was recovering.
64 2021-03-18 fever, fatigue, chills For two days following the vaccine (March 6 & 7) I experienced severe body aches, fever, chills, fat... Read more
For two days following the vaccine (March 6 & 7) I experienced severe body aches, fever, chills, fatigue. Horrible shortness of breath began on the third day, March 8, and continued to worsen. For the next week my breathing became more and more labored with difficulty in functioning and needing to be in a reclining position in order to breathe. By the 10th day, o n March 15th I was hospitalized and subsequently had tests run on heart and lungs. My blood oxygen would drop to the low 80's if I took just a few steps. Today, on March 19th I am home and slowly improving but still needing to be mostly resting.
64 2021-03-18 fatigue, chills, cough, headache, fever extreme congestion; Loss of appetite; nausea; fever; chills; headache; fatigue; dry cough; injection... Read more
extreme congestion; Loss of appetite; nausea; fever; chills; headache; fatigue; dry cough; injection site pain; pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 03:00 PM (at the age of 64-year-old) on Left arm at single dose for covid-19 immunisation. The patient's medical history was not reported. Patient had unspecified other medications in two weeks. The patient previously took first dose of BNT162B2 (Lot number: EL9262) on 22Jan2021 at 02:30 PM on Left arm at single dose for covid-19 immunisation and had vancomycin and experienced drug allergy. The patient experienced Loss of appetite, nausea, fever, chills, headache, fatigue, dry cough, extreme congestion, pain at injection site and aches on 10Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
64 2021-03-21 headache Bad headache; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 64-year-... Read more
Bad headache; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 13:15 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus, asthma, and GERD. Concomitant medications included alprazolam; omeprazole; sitagliptin (JANUVIA [SITAGLIPTIN]); all taken for unspecified indications, start and stop dates were not reported. The patient previously took flagyl [metronidazole]: Known allergies: Flagyll. On 18Feb2021, the patient experienced bad headache, nausea, and vomiting. The patient did not receive treatment for the events. The outcome of the events was not recovered.
64 2021-03-22 headache, chills dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well o... Read more
dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well over 12 hours; stomach pain; big bump on my head where I hit the tile floor; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 05Mar2021, 16:30 as a single dose for covid-19 immunisation. The patient's medical history included allergies to Sulfa based meds from an unknown date and unknown if ongoing. The patient had Covid prior to vaccination. Concomitant medications included cranberry; colecalciferol (D3), fish oil, and multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 05Mar2021 at 18:30, the patient experienced headache, nausea, arm soreness 2 hours after injection. Chills for well over 12 hours. Most concerning, patient got up in the middle of the night. Used facilities. Washed hands, and was having stomach pain. Then she passed out. she came to, and have a big bump on her head where she hit the tile floor. Sunday Morning (07Mar2021) she was dizzy. Maybe from the bump on her head. The patient did not received treatment for the events. The outcome of the events was recovering at the time of the report. The has not tested positive for Covid-19 post vaccination.
64 2021-03-24 cough, throat irritation Itch in throat, cough, swelling in throat and body itching
64 2021-03-24 malaise, chills, fatigue, headache tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous ... Read more
tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Feb2021 at 14:00 (at the age of 64-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient did not receive any other medications in two weeks. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 13Feb2021 at 22:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell. Therapeutic measures were not given for the events. The clinical outcome of the events tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
64 2021-03-30 chills, cough Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a s... Read more
Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a spontaneous report from a contactable retired nurse. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), at vaccination age 64-year-old via an unspecified route of administration in the right arm on 13Mar2021 09:30 as a single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient reported that she had side effects after getting her first dose of the Pfizer COVID-19 vaccine Saturday morning (13Mar2021) at 09:30am. She mentioned that she developed side effects Monday (15Mar2021) night that she also had all day Tuesday (16Mar2021), it was pretty significant. She mentioned that she is concerned about getting the second dose, and she is thinking that she is not going to get that after having her first dose. She stated that her side effects lasted all night Monday night, she had shortness of breath and coughing. She added that on Tuesday morning she started having chills, shakes, throwing up or vomiting, and having massive diarrhea all day long. She also mentioned that she thought it was serious, and she was going to have to go to the hospital soon. She wasn't going to have a choice if it hadn't gotten better. She reported that all her side effects are better, and that for treatment, she took some Delsym cough medicine and diarrhea medicine, Imodium, she thinks it was called. She says she took one dose of the cough medicine yesterday morning, and she has taken 3 doses of Imodium today. She wondered if she should take the second shot or if she would get the same symptoms again. She says she is hesitant to take second one because she doesn't want respiratory distress again (Mar2021), it was horrible, and she has never had massive diarrhea before to where she couldn't get to the bathroom, it was the worst thing she has went through. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect productbnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), to reported events is possible.
64 2021-03-31 fatigue At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt a... Read more
At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt as if my heart was vibrating. I am sure later I had a TIA. Was unable to communicate. I knew what I wanted to say but I could not get the words out. March 1/2021 I went on FLMA. It never dawned on me the vaccine could have affected my already stressed heart. I am still experiencing these symptoms. I just thought of this this week. I still have extreme fatigue, increased palpitations, and increased SOB. I do not feel able to work right now.
64 2021-04-01 fever, fatigue continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; sli... Read more
continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; slight pain at injection site; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 64-years-old, administered in Arm Left on 26Feb2021 09:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergies: sulfites. The patient was not pregnant. There were no concomitant medications. The patient experienced slight pain at injection site and tired on 27Feb2021 12:00, nausea, slight fever, and difficult breathing on 28Feb2021, continued throwing up, diarrhea, shortness of breath on 01Mar2021. The patient experienced slight pain at injection site, tired on Saturday, then on Sunday nausea, slight fever, difficult breathing, and on Monday continued throwing up, diarrhea, and shortness of breath. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 08Mar2021.Therapeutic measures were taken as a result of the events which included steroid and meds for stomach. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The outcome of the events was recovered on an unspecified date. Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. Information on the lot/batch number has been requested.
64 2021-04-02 headache, head discomfort, malaise headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad press... Read more
headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad pressure in the back of her head; felt like her heart was skipping beats; heart rate and blood pressure seem to be very erratic; erratic heartrate; arm swelled up and was sore; arm swelled up and was sore; lump in throat; unwell feeling all over like she was going to pass out.; unwell feeling all over like she was going to pass out.; She kept getting an icky feeling; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [26Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot Number: EN6204), intramuscular, administered in right arm on 08Mar2021 14:10 (at the age of 64-year-old) at single dose for Covid-19 immunization. Medical history included high cholesterol, osteoporosis, high blood pressure, arthritis, stenosis of neck and spine, allergies to dust and cleaners (when she cleans, the bottom of her neck swells up huge); all were ongoing. She has very high cholesterol, she believes it was close to 400 the last time it was checked and that's why she was given Repatha which brought it way down, but she doesn't know if she can take the Repatha again. She also has quite a few allergies - allergic to cats, sulfa, grass and Pre-diabetes. She has a fair amount of allergies. Her doctor thinks she has some asthma because she has had a little trouble breathing at different times, but she doesn't have an inhaler or anything. She mentions asthma and allergies run in her family. The patient also stated that a majority of her life, has had low blood pressure until about 9 years ago when her father passed. States that her blood pressure had been out of control for 6 months and was then put on a low dose of Carvedilol, and eventually evened out. Concomitant medications included ongoing carvedilol taken for blood pressure; ongoing loratadine (CLARITIN) taken for allergies from 1996 (has been taking for 25 years); ongoing lansoprazole taken for acid reflux; ongoing rosuvastatin calcium taken for cholesterol since Sep2020; ongoing calcium; carvedilol (COREG) taken for blood pressure. The patient had a previous reaction to a cholesterol medication evolocumab (REPATHA) from 23Oct2020 to 23Oct2020 - her neck swelled up pretty big and she had hives on her chest, which ended up going away. Therefore, she doesn't know if she can take that again or not. The patient also previously took rosuvastatin calcium (CRESTOR) 5-6 months ago and it made her legs ache really bad; esomeprazole sodium (NEXIUM) and had the problem; lansoprazole (PREVACID) for acid reflux. She took Nexium which was a different product with different ingredients and her blood pressure was still high the whole day. States that her doctor had prescribed another brand, which had the same main ingredient as the Nexium, and told her to double up on it one night, so she did that and about an hour later she just about hit the floor because her blood pressure shot up to about 200 over 100 and something, so she talked to the pharmacist who said that this was not a normal reaction to the ingredients in Nexium, but it happened to her every time she took it. She had been taking Prevacid for a long time but then started to get an allergic reaction. Clarified that feeling like she was having an allergic reaction after taking the Prevacid at night, was something that she has just started noticing within the last month. Wondering if the 2nd dose of the Prevacid is too much. States that she still takes this in the morning but not in the evening. States that she has started taking 15mg at night from an over the counter version of the same medicine (Lansoprazole). She explained that she hasn't had any vaccines as an adult, she never has had a flu shot. About 5 years ago, she had a bat in the house for 3 days and the bat ended up hitting her in the head and forehead as they were trying to get the bat out of the house, so she ended up getting a rabies vaccine. She was wondering and hoping there were no interactions with that. With the rabies vaccine, she did have a headache. She had to get 4 or 5 shots and she did not feel well most of the time. It took a long time to pass for her to feel normal again. The caller received the first dose of the vaccine last Monday on 08Mar2021, after the shot and while waiting those 30 minutes, she felt a lump in her throat which lasted all day and the next day, but it went away. She confirms by 10Mar2021, she recovered completely. Her arm swelled up and was sore for a day and half on 08Mar2021, but that went away. She isn't worried about that. She also has a really bad headache and was very dizzy on unspecified dates. She is concerned about the dizziness. She has been driving, but about the second day after getting the vaccine, she was leaning over talking to her mom and she felt like she going to pass out. She didn't, but she felt like she was. She has been using hot packs. It's like she has a headache around her temples and the back of her head seems to be hurting. In fact, she put a hot pack there while waiting to speak to this call handler. She doesn't know if its tension or what. She didn't have hives or none of that from COVID vaccine which she was excited about, but she is so dizzy she can hardly stand. She can't get rid of the headache and dizziness. She wants to know whether or not to go ahead with the next vaccination. This is the 5th day of having this dizziness. She was thinking the dizziness was going to last for a couple of days, but its going on 5 days. Even just sitting, She states it's kind of scaring her. She was thinking it would just go away, but it isn't. Her heart rate and blood pressure seemed to be very erratic on 12Mar2021. She woke up this morning (12Mar2021) and her blood pressure was very high, but she checked it within a few minutes and was dropping low. Her heart goes fast and then slows down, but she has had problems with this in the past. The dizziness has been bothering her a lot, she has been afraid to drive. The patient had a blood pressure of 150/102 on unspecified date. On 17Mar2021, She mentioned she will see her HCP at 2:00 PM. She has already filed a report regarding the side effects she had. She filed a report and asked if she should get the second dose shot. However, she was informed if her HCP called, they may be able to provide her with more information. She was informed her HCP could call the medical line. On 26Mar2021, she stated that the first report was filed the first week and that during the second week, more not good things have been happening. She wrote down the report number from the first report but does not have it now. Since the vaccine, she has been having different symptoms; she is not sure if it is related to the vaccine but wanted to report it. She was a little concerned because she has allergies, stating she had just tried an injectable cholesterol drug and she did break out hives and her neck had swelled. States that she has not had any vaccines as an adult, so she was a little bit cautious anyway. She clarified that she did not have hives and did not have any breathing problems when she left. Stated that later that evening and the next day had a really bad headache and bad pressure in the back of her head, which she knew was typical. States that 3 or four times she felt a rush over her body and felt like she was going to pass out. That night and the next day (unspecified date), she was having breathing problems (was not breathing very well for 3- 4 days) and her chest was tight and she was starting to wheeze, and continued for about 3 or 4 days. She kept getting an icky feeling Monday and Friday when she got up and had unwell feeling all over like she was going to pass out on unspecified date in Mar2021. States she had real bad pressure in her head and high blood pressure and felt like her heart was skipping beats on unspecified date. States her blood pressure was around 152/100 on 09Mar2021. One-day blood pressure was real low, 88 over something but that kind of went away. States all that information was already reported. The next week, she thought she was feeling better and that Monday and Tuesday felt back to normal. Stated that on Thursday night (Mar2021), she was just sitting and around 8 o'clock her blood pressure spiked within a few minutes to around 184/105 and she wasn't doing anything; she couldn't get it to go down. States that she went to the ER to check everything out last Thursday. Every night since then, somewhere around 8 o'clock, her blood pressure spikes really high. Stated she then called her doctor. Stated she was on a really low dose of blood pressure medication, stating that she had occasional problems with her blood pressure in the past but it never went that high. Her blood pressure was usually in the 140's or 150's over 90 something. States that now it is much higher and happening every night. Caller stated that Wednesday night (24Mar2021) her blood pressure started to spike every 5 to 6 hours, stating it first started at 830 at night and again at 230 in the morning. She has been feeling unwell since that shot. Her doctor thinks it may be causing inflammation. States that they doubled her medication last night and her blood pressure is still going up and up, but usually goes down after a couple of hours. It is totally uncontrolled and her doctors are trying to figure it out. States that meds have been added, including Xanax and will be going to see a heart doctor. States that this has all been since the vaccine. Caller would like to know if people are reporting these symptoms. States that it is pretty terrible, and that she feels normal and then it rushes over her. States that it is exhausting and that she almost went to the ER last night. States that she does not want to go back if she does not have to. When she filed the first report she did not have issues with blood pressure yet. Again, she had the vaccine on Monday 08Mar2021 and that the next Thursday she felt like her heart rate was really high. During that first week, she felt out of rhythm, like missing beats. Her blood pressure dropped low the first week and that just one time was around 152/100 but it didn't sustain. It then dropped pretty low one day. The next Thursday, it was uncontrollable. It was around 180 over 104 or 105 and that it kept going up, but then back down to 160/90 something. Took Xanax and went to bed, when she woke up this morning it was low, but went right back up within 5 minutes. In the first couple of days, they increased her blood pressure medicine and it seemed to be bringing her blood pressure down and she was able to go to bed. The caller stated that Monday, it will be three weeks. States that a day and a half after the vaccine, her arm was not hurting but was still puffy, but not bad. States that when she runs her hands over it, it is still sore to the touch and a little swollen but nothing extreme. She was concerned that her blood pressure keeps going up and then down. States that the blood pressure started spiking on the 18Mar2021, in the evening very quickly and was very high. Stated that this was happening every night since then until the 24th, when it started spiking every 5-6 hours; and her blood pressure medicine wasn't controlling it like it was earlier in the week, even though the dose was doubled. For one day it worked good and brought it down low but then, it wasn't controlling it anymore. She stated no relevant tests, related to this event but states that in her last 2 labs her cholesterol was high. States that it was over 300 and her bad cholesterol double or more triple. States this has been going on for many years. States that she changed her calcium to calcium with vitamin D and her vitamin has come back up. When she was in the ER they did a Metabolic panel and everything looked okay. The adverse events require and emergency room visit. The patient recovered from the event lump in throat on 10Mar2021; the events arm swelled up and was sore recovered in Mar2021; the events erratic heart rate, chest was tight, was not breathing very well for 3- 4 days, wheezing resolved on unspecified date. The outcome of dizziness, blood pressure seem to be very erratic was not recovered and the outcome of the remaining events was unknown.
64 2021-04-04 fever, chills, sleepiness Meningo-encephalitis Pt started having fever, chills, altered mental status, drowsiness, confusion.
64 2021-04-06 headache Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling... Read more
Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling in Lt, eye then swelling in Lt. eye lids, lt. cheek, lt. corner mouth which progressed. This was witnessed by the team giving vaccine and later on by EMT on the scene. Post feeling dizzy along with swelling the EMT person had me leave my car & placed me on litter in ambulance waiting in parking lot. Within 5 -6 mins. of the shot, I then felt severe HA, and swelling in my throat. EMT immediately started IV - gave IV Benadryl, then gave 1 shot of Epinephrine. Called EMT which took me via ambulance to hospital. There EM MD assess then gave me Solumedrol IV push & admitted me to ED OBS formally. Felt better but then few hours later all symptoms returned along with severe pain in hand with red palms & cyanotic finger tips. ED MD treated me again with higher dose of Benadryl & add Prilosec for potentiation of Benadryl and observed me. Felt better after several more hours. Was discharged on 50 mg Prednisone X 5 days & prescription for Epinephrine pen. Followed up w/PCP couple days later.
64 2021-04-06 fatigue she is disabled and lives in chronic pain.; Hair is falling out; was too tired; This is a spontaneou... Read more
she is disabled and lives in chronic pain.; Hair is falling out; was too tired; This is a spontaneous report received from contactable consumer, the patient. A 64-year-old adult female received the first dose of BNT162B2 (solution for injection; Lot EN6204 expiry 30Jun2021) as a single dose in the left deltoid (left shoulder) on 22Mar2021 (at 64-years-old), for COVID-19 immunization. Relevant medical history included a failed back surgery. The patient had no family history. Concomitant medications included many [unspecified] medications that the patient has taken for years. The patient denied receiving any prior vaccinations within four weeks of the vaccination, and the patient denied any adverse events (AE) following prior vaccinations. The patient reported that very early in the morning on 24mar20201, she did not know what time as she was too tired to look at the clock, she noticed her hair was failing out. The patient also mentioned that she is disabled and lives in chronic pain from an unspecified date (pending clarification). There was no emergency room visit required and the patient denied any physician office visit though commented she made an appointment with dermatologist for Friday. The outcome of the events too tired, hair is falling out, and disabled and lives in chronic pain was unknown.
64 2021-04-07 malaise, headache, fatigue, fever Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; mal... Read more
Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; malaise; severe Tremor; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 at 15:15 on the left arm as single dose for COVID-19 immunization. Medical history included bipolar disorder type 2, known allergies to sulfa. Concomitant medications included taking unspecified other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies. The patient did not have covid prior vaccination and there was unknown if the patient had covid tested post vaccination. On 13Mar2021 at 12:00 PM, the patient experienced severe nausea, fatigue, muscle and body aches, headache, low grade fever, malaise 3 days after vaccine since then patient had developed a severe tremor; that all events resulted in disability or permanent damage. Patient received a positive result from a serum antibody test for covid 19 on 29Mar2021 (reported as two days ago, as of 31Mar2021). Patient cancelled her second vaccination appointment. Lab data included serum antibody test was positive on 29Mar2021. There was no treatment received for the adverse events. The outcome of events was not recovered. Information about Batch/Lot number has been requested.
64 2021-04-07 fever, fatigue, headache, chills pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and ... Read more
pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering. Additional information has been requested.
64 2021-04-08 malaise, fever, fatigue Pt received the shot on Thurs 4/1/21. This is a 64-year-old patient who presents with 1-1/2 days of ... Read more
Pt received the shot on Thurs 4/1/21. This is a 64-year-old patient who presents with 1-1/2 days of body aches, fevers, tachycardia, fatigue and does not have any exposure to COVID-19 but she just got on Thursday her first shot of her vaccination she also has vomiting and malaise. TTP rash started on 4/7/21.
64 2021-04-09 sweating feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain... Read more
feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved. She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered. Information on the lot/batch number has been requested.
64 2021-04-17 headache Lymph nodes hurting a lot; Hypersensitive to light; A lot of dizziness; Nausea; Headaches; affecting... Read more
Lymph nodes hurting a lot; Hypersensitive to light; A lot of dizziness; Nausea; Headaches; affecting all organs; Chest pain; Felt like the Covid-19 vaccine was hydrating eyes/Film on eyes; Losing vision; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), first dose via an unspecified route of administration on 16Mar2021 10:30 (at the age of 64 years old), single dose for covid-19 immunisation. Medical history included ongoing thyroid (disorder) (Unspecified thyroid condition). It is the vaccines with aluminum and bovine extract that she knows that she can't handle. Caller reported that she got a flu vaccine at work and that she definitely got the flu within a few minutes of receiving the flu vaccine. Caller reported that another time after receiving the flu vaccine, she definitely got the flu but she was unsure of the time frame. Caller reported that she did have the flu vaccine several times but that two times, the flu vaccine definitely gave her the flu. She has 3 brothers and that one of her brothers that she is a caregiver for has Type 1 Diabetes. Her brother just felt like he had to have 2 vaccines several years ago and that he received the pneumonia and flu vaccines. Her brother was hospitalized within days of receiving the flu and pneumonia vaccines. Her brother was placed in the ICU for heart patients and the medical staff at the hospital was not sure if her brother was going to live. She couldn't remember how long her brother was hospitalized for, caller stated she thinks maybe around 10 days.She knows what she knows, her 2 other brothers were also hospitalized as children. She didn't know if her brothers had vaccines before they were hospitalized but that she would bet money that vaccines they had received are what resulted in hospitalization.When hospitalized, her second brother was not expected to live. At the time of the event, her brother was only 1 or 2 years old. Her brother's infection was so bad that the hospital sent blood to the CDC and that the CDC couldn't figure out what was wrong with her brother.The hospital kept giving IV antibiotics to her brother and he lived. Her third brother hospitalized around 5 years old with pneumonia during the summer. She didn't know if her brother had received any vaccinations at that time. She just thinks the vaccines did that to them but she doesn't know that. Someone gave her first brother the information on the pneumonia and flu vaccines he received prior to his hospitalization. She didn't have information regarding the details of the vaccines that her brother received.The facility where her first brother was vaccinated with flu and pneumonia vaccines would not give her the information on the vaccines that her brother received. Caller reported that it was a really hard time to fight the facility for that information and she was shocked the facility wouldn't give her the requested information. Caller reported that they wouldn't give her any medication records or anything. Caller reported that it was a bad time for her to fight it, and that she will eventually go back and tell them they have to give her the information.Her brother that she is a caregiver for and that was hospitalized after receiving the flu and pneumonia vaccines also had the Covid-19 vaccine on 16Mar2021. Caller reported that she had been more concerned about her brother having a reaction as he has serious health issues, including Type 1 Diabetes and a heart condition. Caller reported that her brother stated that he's fine and to the caller, her brother seems fine. Concomitant medication included levothyroxine. Patient has experienced that the Pfizer Covid-19 vaccine made her hypersensitive to light on 20Mar2021. She is losing vision on Mar2021 because of the hypersensitivity to light. On 20Mar2021, patient had a lot of dizziness and nausea. It is effecting all of her organs. She has had headaches, chest pain. The Covid-19 vaccine is affecting all of her organs. Yesterday, 30Mar2021, her lymph nodes were hurting a lot, at least she thinks it was her lymph nodes. All of her organs that have been affected by the Covid-19 vaccine and that it seems like it moves day to day. She is mostly sensitive to UV light but is also sensitive to artificial light. She thinks that the hypersensitivity to light has improved a little bit but it's still a problem. The hypersensitivity to light was the absolute worst on 20Mar2021. She doesn't know how much she is still dizzy when asked if it was still ongoing. She added she has been taking Benadryl and ginger for the dizziness and nausea and it helps a lot.She has been taking ginger for the nausea, and if she still has a little, it's not as much.Today is an overcast day and that it's an easy day for her. Caller reported that bright, sunny days are the worst.She was unsure of when the vision loss occurred but stated that she knew by 20Mar2021 that she had lost vision. She didn't know if she was continuing to lose vision but she can tell she lost vision. She did have a headache in the evening on 16Mar2021 after receiving the Covid-19 vaccine. She thinks the headache occurred in the evening on 16Mar2021.She may have had some headaches between 16Mar2021 and 20Mar2021, but that the headache she had on 20Mar2021 was a horrible headache.She is still getting headaches. She would say the headaches are a little better but she is still having them.She is having headaches that she doesn't think she would normally have. She wasn't having headaches before receiving the Covid-19 vaccine.She thinks she did have headaches between 16Mar2021 and 20Mar2021, but 20Mar2021 is when the headaches really hit her.The chest pain is intermittent and that the chest pain coincides with when the light is affecting her. When it's UV light, more so in the afternoon on sunny days, but technically the artificial light in the evening some days bothers her too.She doesn't think her lymph nodes were bothering her before 29Mar2021. Her lymph nodes are ok this morning, 31Mar2021.Different organs have hurt at different times. The effect on organs started within minutes of getting the Covid-19 vaccine.She could feel her eyes and that her eyes felt different within minutes of getting the Covid-19 vaccine. It felt like the Covid-19 vaccine was hydrating her eyes on 16Mar2021 but at the time it felt good. Afterward she was freaking out because she was concerned about her eyes.In the evening of 16Mar2021, it seemed like there was a film on her eyes and she had a headache.On 17Mar2021, 18Mar2021, and 19Mar 2021 she had headaches that she wouldn't have normally had.On 20Mar2021 different organs started hurting.Her biggest concern was the chest pain. After looking back on it, the chest pain may have started between 17Mar2021 and 19Mar2021 also.The effect on her organs from the Covid-19 vaccine occurs on different organs at different times on different days. The effect today isn't bad because it overcast outside and that her organs are really affected when she is exposed to a lot of light.She had 2 blood tests yesterday at her primary care doctor. The doctor ordered labs for VEGF and Leptin. She doesn't get vaccines.No Prior Vaccinations (within 4 weeks). The outcome of the event Photophobia, Nausea, Headache, Lymph node disorder was recovering; other events was unknown. Follow-up attempts are completed. No further information is expected.
64 2021-04-17 fatigue heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe ... Read more
heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours; body feels like hit with mac truck; tired; This is a spontaneous report received from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm at age 64 years, on 29Mar2021 14:25 (Batch/Lot Number: ER8732) as single dose, for COVID-19 immunisation. Medical history included atrial fibrillation as a pre-existing condition that normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most and overweight from unspecified date but working on it. Only she has heart history in her family. The patient's concomitant medications was none. Patient historically took first dose of BNT162B2 (Lot: EN6199) with anatomical Location of left arm on 08Mar2021 around 1300 for COVID-19 immunization and flu vaccine received back in 2020 for immunisation. Patient reported that she had the second dose of the Pfizer COVID Vaccine on Monday, 29Mar2021 and three hours later, her heart started fibrillating for 36 hours. She has a pre-existing condition of atrial fibrillation and normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours. Patient contacted the doctor right away via phone. Her doctor, an electrophysiologist, stated not to eat or drink anything after midnight and of patient was still in atrial fibrillation in the morning they would have to perform a cardioversion, with the paddles. Doctor believed this could happen and said its a delicate balance when you put anything else into the system that it could affect persons. On 31Mar2021 at 05:15 that morning, the patient went out of atrial fibrillation and back into normal sinus rhythm. Patient only called the doctor and would have had to go in today if the fibrillation did not stop. Patient also stated that well, it was not a good thing to fibrillate for that long, with due time it can cause congestive heart failure and stated its dangerous. Patient was resting at the time of report and was relieved she is not fibrillating anymore. Patient reported that her body feels like it was hit with a mac truck on Mar2021. Heart fibrillating for 36 hours makes you really tired. The outcome of the event 'heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours' was recovered on 31Mar2021 at 05:15 in the morning, while for the rest of the events it was unknown. Follow-up attempts are completed. No further information is expected.
64 2021-04-20 malaise, fatigue Appendicitis; Abdominal pain/abdominal soreness; stomach started bothering her; not feeling well; ti... Read more
Appendicitis; Abdominal pain/abdominal soreness; stomach started bothering her; not feeling well; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 25Mar2021 10:00 at a single dose for COVID-19 immunisation. Medical history included ongoing asthma (Never smoked a cigarette in my life), Hypothyroidism (started taking levothyroxine about 23 years ago), Diverticulitis (hospitalized for it once in 2015), allergy and environmental allergies. Concomitant medications included levothyroxine for hypothyroidism, loratadine for asthma is triggered by allergies, montelukast for allergy from 2017, fluticasone propionate, salmeterol xinafoate (SALMETEROL AND FLUTICASONE) taken for asthma from 2017, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma attack and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for environmental allergies from 2017 all were ongoing. The patient previously received first dose of BNT162B2 on 03Mar2021 for COVID-19 immunization (IM left arm); flu vaccine (Received every year for the past 14 years) and pneumonia vaccine (gotten the pneumonia vaccine the year prior) both for Immunisation. On 26Mar2021, caller stated that she was not feeling well, her stomach started bothering her and she thought she was going to have diarrhea, but she did not. She was really tired, stating she had to take her mom to an appointment, which was about an hour away and patient slept in the car on the way, and noted that she never sleeps in the car. Felt really really tired. On 28Mar2021 her stomach pain started. She thought it was diverticulitis and that she has history of having diverticulitis years ago and being hospitalized for it once in 2015. She got very sick very quickly. She went to the emergency room on 28Mar2021 at about 1130 and they did a CT scan and found out it was her appendix and she was operated on that afternoon at which time they removed her appendix. Appendicitis require a visit to the emergency room. The patient was hospitalized for appendicitis from 28Mar2021 to 29Mar2021. The doctor told her that she was very fortunate, there was a slight perforation and there was no leakage and she was able to go home on early Monday evening. Shortly after the surgery she felt better. She still does not feel 100% still tired. Glad she got the surgery when she did and it did not rupture. Stated she did not need pain medication. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events appendicitis and stomach started bothering her was recovered on 29Mar2021, not feeling well recovered on 28Mar2021, event tired as not recovered while unknown for the other event. Information on the lot/batch number has been requested.
64 2021-04-21 chills Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my lef... Read more
Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest. My chest was tight. It hurt in my neck and shoulder and chest to take a deep breath. Shortly after, I felt jittery inside & started getting chills. The backs of my legs were quaking against the chair and I got really cold. My blood pressure went up to 149/78. I also had one bout of diarrhea.
64 2021-04-23 malaise itchiness/itching on both legs; body malaise; This is a spontaneous report from a contactable consum... Read more
itchiness/itching on both legs; body malaise; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3242), second dose via an unspecified route of administration in right arm on 03Feb2021 as SINGLE DOSE for covid-19 immunization. The historical vaccine included First Dose of BNT162B2 which was on 02Jan2021 (Lot: EL3302) in right arm. The patients medical history included diabetes mellitus and blood pressure. Concomitant medications included LISINOPRIL taken for blood pressure and METFORMIN taken for diabetes mellitus, both on unspecified date. On 04Feb2021 the patient experienced body malaise and itchiness/itching on both legs. Outcome of the events was not recovered.
64 2021-04-24 headache, fatigue, body temperature increased Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms las... Read more
Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation. Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported. On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
64 2021-04-24 fatigue, malaise I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hea... Read more
I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hear it, could felt it in my chest. Then trembling; heart palpitations and it was skipping and trembling off and on; arm is sore; weird feeling; trembling; trembling, shaking and she thought she was going to have a seizure, she had no control over her muscles; muscles twitching, like if I had no control over the muscles; she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot; didn't feel good last night; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 13:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 64 years old. Medical history included cholesterol (abnormal, takes cholesterol medication 3 times a week as she gets side effects from it), cutaneous lupus (She always has to do bloodwork and goes in every 3 months), heart problem that is not major (she takes 1 medication, patient stated once in a while she sees her cardiologist every 6 months and she did get a halter monitor for 24 hours for a week and they take an average and said it wasn't as bad and knows that is a problem), 2 cervical spine surgeries, arthritis, allergic to contrast dye for CAT scans, allergy to medications (sensitive to medications), shrunk a lot because of issues, and had surgery which shrunk her because of her spine from an unknown date. Concomitant medication included atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal from 2016 and ongoing; and nadolol (CORGARD) taken for an unspecified indication from 2001 and ongoing. Patient's son got COVID on an unspecified date. Patient previously took generic atorvastatin which made her sick on an unspecified date and LIPITOR and experienced muscle weakness on an unspecified date. No additional vaccines administered on the same date of the Pfizer vaccine. No prior vaccinations. Patient never got a flu shot as she was scared. On 06Apr2021, her arm was sore which is normal. Normal side effects from the arm did not concern her, patient had no fever nothing else. She stated she came home and felt like she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot and she made sure of that. At 19:00 (also reported as 7-8pm), patient experienced her heart was skipping really bad. Patient could hear it and could felt it in her chest. Patient clarified her heart was not fast, it was more skipping, and she could feel it beating in her throat. She commented has a problem but that has not happened in a long time. Patient then experienced trembling described as lots of body trembling concerned like a seizure. She thought she was going to have a seizure. It was not chills; she had no fever or anything. The trembling came on and off. Her muscles were twitching, like if patient had no control over the muscles. Patient did not feel dizzy, it was a weird feeling. She did not feel good. On 07Apr2021 at 02:00, patient felt very tired and weak, her heart was better. About 02:00 she fell asleep. She woke up at 6:30 and she felt tired but that does not bother her. Her concern was the body trembling. She called her doctor but was not available. She was advised that it does not sound like a symptom of the vaccine. She was worried she needs to go to the cardiologist and see what is happening. She stated if it keeps happening, she will go, and she does not know if this is a side effect other people are reporting. Patient was wondering if this is a reaction as she cannot find it, one says a severe reaction is a fast heartbeat, really fast and skipping and she does not know. She expected anything, tired, headache, muscle aches but these did not happen, but she was expecting them to. Patient is wondering why her heart is doing that is it from the shot or what is going on with her which is weird, and stated the shaking, trembling of her whole body is weird. She mentioned she is sensitive to medication and gets reactions to a lot of medications. She stated this is why she was scared to get the vaccine and what the reaction was with the 1st. Patient stated her heart is a lot better than it was last night, that she feels very tired and feels unwell. She stated she took her temperature (Apr2021) and she had no fever, no nothing a little unwell, a weird feeling. Patient stated she is not trembling anymore and has no heart skipping, that went away about 2am when she fell asleep for a few hours (also reported as went away after about an hour, she had it off and on 3-4 times in an hour). Patient clarified she has not had testing done for the reported symptoms. The patient stated she is concerned and does not know what to do about second dose, which is scheduled for 04May2021. She does not if it was a reaction and stated she is very sensitive to medicine. Events did not require emergency room and physician office visit. Outcome of the event heart was skipping, tremor and palpitations was recovered on 07Apr2021 02:00 while unknown for the other events. Follow-up attempts are completed. No further information is expected. Lot number has been obtained.
64 2021-04-24 sweating, headache passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head seve... Read more
passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head severe pain; dizziness; vertigo; nauseous; heavy sweats; my head feels very foggy; Having spots of memory issues; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 30Mar2021 11:30 (Batch/Lot Number: EM9810) as single dose for covid-19 immunization. Medical history included asthma, neuropathy, high cholesterol, and several allergies from an unknown date. The patient has no history of COVID prior vaccination. She was not COVID tested post vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number=EN6200) on 09Mar2021 12:15, on left arm for COVID-19 immunization. The patient experienced having left arm, shoulder and neck completely numb for four days since 30Mar2021, 19:00. Left lower section of her head with severe pain; she had dizziness, vertigo and was nauseous. She started having heavy sweats and passed out two times. She reported it has been a week since she had the shot and she was still dizzy and her head feels very foggy. She was also having spots of memory issues. The events were experienced on 30Mar2021, 19:00. No treatment was received for the events. The outcome of the events was not recovered from dizziness, and recovered with sequela from "Left arm shoulder and neck completely numb" on 03Ape2021, and recovered with sequelae on an unspecified date for other events..
64 2021-04-24 fatigue she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness... Read more
she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness of breath; kind of fatigued; This is a spontaneous report received from a contactable consumer reporting for his wife (patient). This 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), single dose, dose 1 via an unknown route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included aortic aneurysm from 2012 to 2012, thyroid problems and headache. There was no family history. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. There were no events following prior vaccinations. Concomitant medications were not reported. In Mar2021, a week after vaccine administration, the patient was kind of fatigued. She went to the doctor in Mar2021 because she was feeling bad and they said they could hear wheezing in the stethoscope when they listened to her lungs. She was sent her for x-ray and they are waiting on the results. He said that this can also be symptoms of something going on with her thyroid and he has been trying to get her to go to the doctor. He stated she goes up and down the stairs at work and hasn't had problems but has noticed she feels weak and he has noticed she is getting more fatigued everyday. On 24Mar2021, the patient had no energy and her blood sugar has been dropping sometimes at lunch and has never had problems with it before. it is not all the time but when she comes home for lunch after she eats, it drops low. It happens sometimes at lunch, never at breakfast nor supper. In Mar2021, the patient experienced shortness of breath for the last couple of weeks, especially with the stairs. The patient went to the physician's office on 07Apr2021. Laboratory tests included blood work due to the patient's thyroid problems, blood sugar decreased and chest x-ray all on 07Apr2021. The clinical outcome of weak, shortness of breath, feeling bad, wheezing, fatigued and blood sugar dropped was unknown. No follow-up attempts are needed. No further information is expected.
64 2021-04-24 fatigue, malaise, headache slight swelling; no energy; shooting pain into her ear; She asked if this could be a lymph node situ... Read more
slight swelling; no energy; shooting pain into her ear; She asked if this could be a lymph node situation, She stated this pain has been going on since Thursday night; I started headache with my TMJ and the left side of face; I don't remember a lot of it, we're like that, I can't concentrate, around in my ear; it hurts to open my mouth really wide sometimes; bothers to swallow; just actually feeling unwell; Spot below your jaw bone in your neck; pain in my ear; I still feel very tired; messed with her TMJ on the left side; extremely tired; This is a spontaneous report of a contactable consumer (reported for herself). A 64-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration in the left arm, administered on 30-Mar-2021 at 14:45 (Batch/Lot number: ER8727) as SINGLE DOSE for covid-19 immunisation. The patient medical history includes blood pressure and cholesterol. Concomitant medications included ascorbic acid/rosa canina fruit (VITAMIN C & ROSEHIP) (started 20-25 years ago) at 1000 mg, twice a day for immune system, ongoing, calcium phosphate/colecalciferol (CALCIUM plus D) at twice a day for bone health. Vitamin E (Capsule, soft) for cancer preventive 400 iU, once a day(night) , potassium acetate (Solution for injection), 99 mg, twice a day, magnesium sulfate (Solution for injection) 400 mg, once a day (morning) for unspecified indication, multivitamin/sambucus nigra/sodium, zinc (Chewable tablet) one every other day; fish oil at 500 iU, once a day (morning) taken for cholesterol; colecalciferol (VITAMIN D3 1000) at 1000 iU, twice a day taken for an unspecified indication from 06Apr2021 and ongoing; ascorbic acid/betacarotene, calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide (PRENATAL VITAMINS) at every other day taken for Hair; pravastatin at 80 mg, once a day(night) taken for cholesterol; zinc chloride (Solution for injection) at 50 mg, twice a day taken for bone health and immunity health; acetylsalicylic acid (ASPIRIN (E.C.) at 81 mg,twice a day, loratadine at 1 tablet taken for an unspecified indication from Oct2015 and ongoing for all drug from an unspecified start date and ongoing. ibuprofen (ADVIL 12 HOUR); amlodipine besilate (Film-coated tablet) taken for blood pressure; atorvastatin calcium at 80 mg taken for cholesterol; omeprazole; fluoxetine hydrochloride (FLUOXETIN) 40 mg. It was reported that she had the first dose of the vaccine and has been having fatigue/tiredness/no energy. She stated she would compare it to if you have had surgery and go home and the anesthesia keeps kicking you. It makes her want to sleep a lot. Additionally, around her ear/jaw/TMJ area when she pushes on her neck it sends shooting pain into her ear. She asked if this could be a lymph node situation. She stated this pain has been going on since Thursday night. She asked if these symptoms are from the vaccine and if they just have to run their course/how long do they last. She took an Advil for swelling but it did not do anything. She was scheduled to get her second dose a week from today. It was also reported that Vitamin C she started taking it years ago, 20-25 years ago for immune system, Calcium plus D she started taking it years ago. She is supposed to take at least 1000. Vitamin E she started taking it many years ago. Regarding Potassium her doctor wants her to continue to take that. In her lab work last year her potassium was low. States she started taking it at least 20 years ago, longer than that, not sure. Magnesium the doctor before told her she should be taking at least 400 mg so she does when she can get it, sometimes she takes 250 mg. Caller states she started taking it 20 years ago. Multivitamin it was Normal CT Plus Equate, same as Centrum. States it had Lutein and she started taking some several years ago. Products Multivitamin was taking for general purposes, health protection. Additional Information for Fish oil states she accidentally grabbed 1000 IU so right now is taking 1000 IU. States she started about 10 years ago. States her cholesterol reporting is really good. Products vitamin d3 she was concerned she wasn't getting enough and she just started taking it a week ago. Pravastatin: Caller states it was good for other things too but the main reason was cholesterol. States she was guessing maybe in 2009, usually takes 40 mg and he raised it to 80 mg. Zinc she started taking it maybe 15 years ago. coasted aspirin she started taking it probably 3 years ago. Loratadine it was over the counter, Equate Loratadine. States it seems to work pretty well. She had a cough that wouldn't go away in the fall, the doctor told her to take one every day. Caller states from the day she got her vaccine she has been extremely tired, no energy, and is normally pretty quick on and more her feet. Sometimes she takes 3 naps a day, and still sleeps for eight hours. She is just really, really tired. She feels like when she's had surgery and came out of the hospital and anesthesia is kicking her and makes her want to sit. States it's messed with her TMJ on the left side but it continued to get worse, feels kind of like the mumps. She had the mumps as a kid and doesn't remember much about it, but discovered it wasn't it because she was able to drink milk. States she drank milk and was able to eat and drink. States it is concentrated around her left ear and sometimes aggravating to swallow, push something below her jaw bone and shoots pain into her ear. When probed for outcome she stated she was extremely tired the other day but got enough energy to vacuum and wash the dishes, but took about 3 naps a day for two days after that. pain- Stated initially she has taken Advil for the pain in the jaw. However, it does not phase it. She is not really supposed to take it, but didn't do anything when she took it a couple of times, so she thought maybe she just should not take it. States the pain is the same as it was yesterday and the day before. Confirmed outcome as persisting. Prenatal vitamin Caller states it was normal over the counter. States it is Vitamin A 4000 IU, Vitamin D 400 IU, Vitamin E 30 IU, Thiamin 1.8 mg, Riboflavin 1.7 mg, Niacin 20 mg, Vitamin B6 2.6 mg, Folic Acid 800 mcg, Vitamin B12 8 mcg, Calcium 200 mg, Iron 28 mg and Zinc 25 mg. Caller states she was taking Tylenol and Advil for pain. She took Tylenol this morning but can't say it's done anything yet. She clarified the Tylenol is 500 mg Equate Tylenol, it did not seem to be working, she took it two hours ago. Patient didn't remember a lot of it, we're like that, she can't concentrate, around in her ear, where you know TMJ is, and it hurts to her my mouth really wide sometimes, it bothers to swallow and she can push on a she did not know what it was the spot below your jaw bone in your neck and it shoots up the pain in my ear and she just wonder, and she know, Consumer further stated, 'Yes, just actually feeling unwell.' Consumer was informed about the department: consumer stated, 'Yes she thought she was talking to some one. she was told to hold on the line.' At site of vaccination: consumer stated, 'Left shoulder muscle at the top.' Probed for any Medical conditions or Concomitant medications. Outcome of the event messed with her TMJ on the left side was not recovered. Outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.
64 2021-04-24 headache, fever stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous... Read more
stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0151), via an unspecified route of administration, administered in left arm on 05Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Mar2021 for COVID-19 immunization. The patient had no other vaccine in four weeks. It was reported that on day two (06Apr2021), the patient past out and vomited. The patient also experienced headache, nauseous, fever, bodyaches on 06Apr2021; and stomach ache on 10Apr2021. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The outcome of the events was not recovered.
64 2021-04-27 malaise, fever, dehydration ? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient ... Read more
? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient is sick with vomiting and diarrhea ? Friday, April 9th ? Patient is delirious and still sick with vomiting and diarrhea. She is also has pain in her stomach. An ambulance is called to take her to the hospital. The hospital determines her white blood count is elevated, indicating an infection. Blood sugar is very high ? approximately 400. Covid test is negative. She is restless upon arrival. She tries to climb out of bed continuously. She is restrained. o Saturday, April 10th ? Patient is running a fever and is in pain. She is also confused and doesn?t recognize her oldest sister. Meds are administered to handle both items. (Toradol?). Blood sugar around 200. She continuously counts and calls for Mother and Father. Patient continues to be restless o Sunday, April 11th - at request of family, a CT scan is done of her stomach and abdomen. Nothing is found. Potassium was at 3.2 (normal is 3.5) so she received an IV drip to help with potassium levels. Sugar ? 206. Later drops to 176. Patient calms down some. She is still confused and doesn?t recognize her oldest sister. ? Monday April 12th ? the hospital attempts to do an MRI, but patient panics. This is a closed MRI and her 1st husband died in one. The MRI isn?t done. ? Tuesday, April 13th ? she is asked by the doctor to state her name and wiggle her toes. She complies. Doctor orders speech therapy. She is sedated for an MRI and a CT scan. Both are successfully completed. She sleeps for the rest of the day. Blood sugar ? 274 @ 5:09pm. ? Wednesday, April 14th ? Patient was asleep all day. Most of the day she isn?t responsive when nurses come in and do things like take blood. She normally responds even if she is asleep. Around 5pm she starts to respond and make noises; she briefly opens her eyes then falls asleep. She continues to run a temperature. ? Thursday, April 15th ? Patient is asleep most of the day. She is responsive when nurses do things like take blood. A spinal tap is performed. There was mention of dementia. Hospital is sharing little information, varying from she is retreating into herself vs. something worth isolating is going on. Temp was 102.3 at 7:37, but later dropped to 99.3 without meds. Dr. (neurologist) provides an update to the family. Tests so far are negative. EEG showed sleeping brain (she was asleep during test). MRI showed nothing. Spinal tap negative so far. No infection or anything has shown up. Orders another EEG and MRI ? Friday, April 16th ? Patient tried to open her eyes. ? Saturday, April 17th ? a met code was called on her and she was moved to ICU. A circulation issue was found in right leg. Occlusion was really bad. Initially the doctor was concerned about blood clots. None were found, just swelling. Pressure was relieved. Blood pressure issues. She was put on 2 blood pressure meds, at least. She was dehydrated and acidic. Diabetic ketoacidosis was mentioned. A cytokine storm was expected. ? Sunday, April 18th ? blood pressure not stable. She was put on dialysis. Peripheral circulation was worse. ? Monday, April 19th ? she coded around 5am. Doctors were trying to save her. She passed away about 30 minutes later .
65 2021-01-02 body temperature increased, chills, headache, fatigue Temp. 102, chills, body aches, headache, extreme fatigue; slept most of the day on the 1st; still w/... Read more
Temp. 102, chills, body aches, headache, extreme fatigue; slept most of the day on the 1st; still w/body aches, less fatigue, decreased headache, temp 100 on 01/02; back to normal by 2:00 on 01/02
65 2021-01-03 headache, throat pain Headache, Sore throat gradually increasing over the past 3 days
65 2021-01-03 body temperature increased, chills Jan 3, 2021 mild pain at injection site, diarrhea all day, chills in morning , no fever, temp 97.6 J... Read more
Jan 3, 2021 mild pain at injection site, diarrhea all day, chills in morning , no fever, temp 97.6 Jan 4, 2021 significant arm pain at injection site (awakened by it at 3 am) with chills, temp 99.6. Took One tablet ALEVE followed by temp 98.6
65 2021-01-03 chills, fatigue, fever low fever, chills, aches, foggy head and fatigue
65 2021-01-04 headache Had onset of intense headache and had difficulty breathing. A nebulizer treatment was given and exa... Read more
Had onset of intense headache and had difficulty breathing. A nebulizer treatment was given and examined by a provider. Her husband was summoned to bring her home to rest.
65 2021-01-04 body temperature increased, headache, fatigue, chills I had a temperature of 103.8; nauseated and dizzy; eyes hurting; headache; chills; tired; nauseated ... Read more
I had a temperature of 103.8; nauseated and dizzy; eyes hurting; headache; chills; tired; nauseated and dizzy; pain at the site; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 23Dec2020 at 10:30 as single dose for covid-19 immunization. Medical history included covid-19 from May2020. The patient's concomitant medications were not reported. The patient reported that " I had a temperature of 103.8 " on an unspecified date with outcome of unknown; pain at the site on 23Dec2020 with outcome of unknown; tired on 24Dec2020 with outcome of unknown; nauseated and dizzy on 24Dec2020 with outcome of unknown; chills on 24Dec2020 with outcome of unknown; eyes hurting on an unspecified date with outcome of unknown; headache on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 101.8 Fahrenheit; temperature: 102.4 Fahrenheit; temperature: 101.3 Fahrenheit; temperature: 100.6 Fahrenheit; temperature: 99.2 Fahrenheit; temperature: 103.8 Fahrenheit on 24Dec2020; sars-cov-2 test: positive in May2020, sars-cov-2 test: negative in 23Dec2020. Therapeutic measures were taken as a result of " I had a temperature of 103.8 ". Details were as follows: the nurse received the vaccine on a Wednesday 23Dec2020 at 10:30am. That night at her night shift, she had pain at the site. After midnight, the patient felt tiredness and felt like she had to lay down. At 6:00 she felt nauseated and dizzy. She had a temperature of 103.8. Thursday night, she went home at 7:10 and called her private doctor. The temperature was 101.8 and then it went down. The nurse had been administered the first of 2 dose series of Pfizer BioNTech COVID-19 Vaccine on 23Dec2020. She had received mandatory COVID-19 testing on 23Dec2020, prior to being administered the vaccine; she received the negative results of that COVID-19 testing on 25Dec2020. After being administered the vaccine she was monitored for 15 minutes and then went home. She was fine, had no allergy or anything. She reported that after she was administered the vaccine, she had pain, was really tired, nauseous, chills, high temperature, and her eyes hurting. She mentioned history of COVID-19 in May2020. She works as nightshift nurse at a rehab facility. She woke up that night of 23Dec2020 around 9:00pm-10:30pm and had onset of pain in right arm at injection site which she did not take too seriously because when you get a shot you get pain. Around midnight that night 24Dec2020, she went to work and had onset of being really tired like she just wanted to sit or lay down; she felt like she had to sit down and could not stand well. She continued working that shift on 24Dec2020 but kept getting so tired and had onset of chills and was supporting herself with her med cart. She drank a little sip of ginger tea she brought to work think maybe that would help her feel better. She felt that if she drank more ginger tea she would throw up because she felt nauseous. She was really busy at work 24Dec2020 so she did not check her temperature until after 6:00am which was 103.8 degrees Fahrenheit; and thought no wonder she feels like throwing up. She finished her shift at like 7:00am. For 2 days her temperature was turning high temperature so every 6 hours she was taking Motrin 2-200mg and that would make her temperature go down. Then temperature would go back up to like 102.4 degrees Fahrenheit, she would take ibuprofen (MOTRIN) again, temperature would come down to like 101.3 degrees Fahrenheit. She continued feeling nauseated, having chills, headache and feeling nauseous which she felt all of which could be related to the temperature. She reported to her employee health at work. She thinks it's better. Saturday morning of 26Dec2020, she woke up with temperature of 100.6 degrees Fahrenheit at 7:00am which was the first time her temperature had gown down like that so she did not take the ibuprofen. She checked it again later at like 1:00 pm and temperature was 101.8 degrees Fahrenheit so she took 2 Motrin again. After that her temperature did not go up like that anymore, it was like 99.2 degrees Fahrenheit. As soon as she came from work on 24Dec2020 she called her doctor's office and was seen by Nurse Practitioner who let her out of work for like 2 days. She reported her eyes also have been hurting, mostly her right eye is still hurting, the top is hurting like when you have a small pimple so she keeps checking but does not see anything with her eye. She couldn't even put a cold compress on for the temperature because of her headache and her eyes hurting. She could not even put cold compress to bring her temperature down. Seriousness criteria of all events was unknown. The patient has had no rash, no breathing problems, no coughing, no sore throat or other serious events. She was scared because she wondered if she had COVID-19 again with these events. She mentioned if people do not know these are side effects they would be scared, but she knows from the information she got with the Pfizer BioNTech COVID-19 Vaccine that these are normal for everyone. The only thing she wondered about is if the tiredness she is having is serious or not. She reported prior to getting the COVID-19 vaccine she tested positive for COVID-19 in May2020 and was very sick at that time because she works in a health field with COVID-19 patients. Pfizer BioNTech COVID-19 Vaccine. The patient indicated that she was fine before she got the vaccine; she had no cold, no coughing, no sore throat. The ibuprofen tablet was administered as 200 mg, 2 of the tablets at a time. : The outcome of all the events was unknown. The relatedness of the event, pain to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, really tired to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, nauseous to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, chills to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, high temperature to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, eyes hurting to the suspect drug was reported as related from the reporter using the assessment. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
65 2021-01-04 headache, sweating, fatigue Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 ... Read more
Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Myalgia; headache; anorexia; fatigue; weight loss; sweats; This is a spontaneous report from a contactable physician (patient). A 65 years old years female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9899) via an unspecified route of administration at Left arm on 22Dec2020 01:15PM at single dose for COVID-19 immunization. The patient's medical history included hypertension, body mass index (BMI) 30, hypothyroidism and Covid-19. Known allergies: penicillin, sulpha drugs, seasonal allergies. No other vaccine in four weeks. The concomitant was reported as hydrochlorothiazide, losartan potassium (HYZAAR), levothyroxine sodium (SYNTHROID), Metformin. The patient experienced pain, edema and erythema in 4 cm circumference around injection site myalgia, headache, anorexia, fatigue, weight loss, sweats, all started from 24Dec2020. No treatment received for events. The outcome of the events was recovering.
65 2021-01-04 headache She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose sto... Read more
She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose stools; sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 20Dec2020 at single dose for covid-19 immunisation. Medical history included None. There were no concomitant medications. The patient experienced loose stools on 25Dec2020, headache on 26Dec2020, achy muscles on 26Dec2020, sore arm on 20Dec2020, she thought maybe she had food poisoning bc of the weird symptoms on an unspecified date. She initially had a sore arm and the usual effects which she expected. Then, about six days into it she started having a headache and achy muscles. It all started with loose stool. She did get a COVID test because of signs of COVID. But it was negative. She thought maybe she had food poisoning bc of the weird symptoms. The headaches were bad, but they were not as bad currently. She had a loose stool that lasted a couple of days. The headaches were really mild currently. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Dec2020. Outcome of loose stools, sore arm was recovered in Dec2020, headache was recovering, achy muscles was not recovered, other was unknown.
65 2021-01-04 malaise, fever, headache, chills fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous rep... Read more
fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 21Dec2020 17:30 at single dose for COVID-19 immunization. Medical history included Crohns disease, Penicillin allergy. The patient previously took nystatin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received other unspecified medications within 2 weeks of vaccination. The patient experienced general malaise 22Dec2020. On 23Dec2020, experienced fever, chills, headache, and nausea. On 24Dec2020, experienced malaise. No treatment received for the adverse events. Events outcome was recovered on Dec2020. Information about lot/batch number has been requested.
65 2021-01-05 headache, throat pain After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling... Read more
After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling, sore throat and chest tightness.
65 2021-01-05 headache Dizziness, Headache, NauseaVomiting, terrible vertigo 2 days after vaccine, also very nauseated Narr... Read more
Dizziness, Headache, NauseaVomiting, terrible vertigo 2 days after vaccine, also very nauseated Narrative: Did not have to seek any medical attention, symptoms began to resolve after 3 days, but was off of work for a day. Mostly recovered, just slight vertigo.
65 2021-01-05 headache, fever, chills Fever, chills, headache, nausea.
65 2021-01-05 headache Had onset of intense headache and had difficulty breathing. A nebulizer treatment was given and exam... Read more
Had onset of intense headache and had difficulty breathing. A nebulizer treatment was given and examined by a provider. Her husband was summoned to bring her home to rest.
65 2021-01-05 chills stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is... Read more
stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received bnt162b2, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history included covid-19 from Apr2020 to an unknown date. She further stated that she had COVID back in April and survived. Stated that she had the pneumonia part of it and went back to work in June. The patient's concomitant medications were not reported. On an unknown date, patient was having chills since she had the shot. Stated that her arm was harsh and feels real sore. Patient wanted to know if the chills were common. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
65 2021-01-06 body temperature increased NauseaVomiting Narrative: Received vaccine on 12/28/2020 . Was doing well until one hour before the... Read more
NauseaVomiting Narrative: Received vaccine on 12/28/2020 . Was doing well until one hour before the call. C/O of abdominal cramp, distention, nausea. No vomiting, temperature was 99.7F. No similar episodes before. No rash.
65 2021-01-07 malaise, headache Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; Th... Read more
Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unspecified route of administration in the left arm on 02Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine (unknown manufacturer) and multivitamins. On 02Jan2021 at 03:00 AM the patient experienced abdominal cramps, "someone's pulling my hair", headache, muscle pain, feeling sick, feeling warm with outcome of recovering. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
65 2021-01-07 fatigue Body aches, bone pain and extreme fatigue, loss of appetite
65 2021-01-07 fatigue, chills It was 3 days after I became fatigue and chill. I also had body aches.
65 2021-01-07 chills, fatigue Three days after I became very tired and had chills. Also I felt very achy and did not have a fever.... Read more
Three days after I became very tired and had chills. Also I felt very achy and did not have a fever. The next morning I felt a little better. I had sinus infectious .
65 2021-01-07 headache, chills awake most of the night, body aches, muscle pain, joint pain, chills, nausea, HA, ok today
65 2021-01-07 headache, malaise, chills shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contacta... Read more
shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease. The patient's concomitant medications were not reported. The patient previously took pneumococcal vaccine in 2020 (reported as last year) and she got a flu shot every year with no issues. She had no issues with vaccines in the past. Patient stated that she was calling about the Pfizer BioNtech Vaccine EUA. Patient stated that she had 1st dose 21Dec2020 and then she had reaction on 22Dec2020 23Dec2020 and part of 24Dec2020, she was scared to death, she was having shakes, chills, headaches, body aches. Due to this she would like to know if it is okay to get the second dose. Her second dose is schedule for 11Jan2021. On 22Dec2020 she had the general malaise, like she was punk'ed. She was home that night and got the shakes. All side effects ended on 24Dec2020 by dinner time. Patient stated that they didn't give her anything after getting the vaccine, they just gave information like this phone number, and websites. They gave stuff to read. She got the vaccine at (Hospital name). She has had no positive tests for Covid prior to the vaccine. She had 1 negative test at the end of Aug2020, and that was because she went to hospital for a total knee and they did Covid test then. She has had no antibody tests. Patient stated that she did vaccine reaction reporting on the website provided, she did the online reporting. The outcome of the events was recovered on 24Dec2020. Information on lot/batch number has been requested.
65 2021-01-08 headache Pain Right Arm Headache Pain r side of face and r eye
65 2021-01-08 chills, fever Recipient reported fever and chills.
65 2021-01-08 sweating, fever fever/sweats for greater than a day
65 2021-01-09 fever, headache Tachycardia with first dose on Dec 17, then, with 2nd dose experienced off and on tachycardia and al... Read more
Tachycardia with first dose on Dec 17, then, with 2nd dose experienced off and on tachycardia and also irregular rhythm , no other cardiac related sequels . Second dose, 1/7/21, experienced fever on 1/8/21 of 101.6 off and on that day. Used mainly Advil and Tylenol for fever and headache.
65 2021-01-09 fatigue, cough, fever Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of s... Read more
Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of smell and taste,body aches,I was itchy all over,could not sleep that nite,I called did the Conversation at work and told me not to go to work,the next day 1/3 /21,employee health called me to get tested and tested positive on 1/4/21,I was place on quarantine for 10 days,I tried calling your office with 800 number and left my number nobody called me,I also experienced eye irritation,cough ,short of breath,low grade fever,nausea fatigue
65 2021-01-10 chills, headache Headache, Muscle aches and chills
65 2021-01-10 headache Headache, dizziness, nausea, body aches
65 2021-01-10 lethargy, fever, headache Headache, fever (101.7), nausea, lethargy for several hours on day after vaccine was administered. F... Read more
Headache, fever (101.7), nausea, lethargy for several hours on day after vaccine was administered. Fever broke during the night. Energy level was still low second day after, slight headache that morning.
65 2021-01-10 chills, fever, runny nose, cough I developed rigors with high fever 39.4 C. I was coughing, non-productive cough, pain at the base o... Read more
I developed rigors with high fever 39.4 C. I was coughing, non-productive cough, pain at the base of my lungs from coughing, running nose, muscle pain, GI problems- vomited once and stool foul smelling, loose. I developed hematuria- visit to Patient first, placed on an antibiotic. Continued with high fever and shivers- went to Emergency Department, admitted. Started on cefuroxime- fever and symptoms subsided. Discharged home. One week at home- getting stronger by day. Back to work January 11, 2021
65 2021-01-10 headache Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness... Read more
Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness of the left side of the face and headache on the left side and part of the tongue; The left side of my body, like burning (ankle, elbow); The left side of my body, like burning (ankle, elbow); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular at left arm on 30Dec2020 11:30 at SINGLE DOSE for COVID-19 immunization. Medical history included known allergies to Uva roja. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included atorvastatin (LIPITOR) and fexofenadine hydrochloride (ALLEGRA). The patient previously took titanium and experienced allergies. On 30Dec2020 , the patient experienced numbness of the left side of the face and headache on the left side and part of the tongue. The left side of patient's body, like burning (ankle, elbow). No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered on unspecified date. Information on lot/batch number has been requested.
65 2021-01-10 malaise, chills, fatigue Recipient reported chills, malaise and fatigue.
65 2021-01-10 headache approximately 10 minutes after taking the covid vaccine client started c/o headache, tightness in he... Read more
approximately 10 minutes after taking the covid vaccine client started c/o headache, tightness in her throat, and slight difficulty breathing. She self administered her albuterol inhaler, and was started on O2 AT 4 L.at 10:16 she said that the symptoms were all gone. at 10:24 she said her throat tightness had returned, she was offered benadryl and epinephrine which she refused bc she said she had to drive home. she took benadryl po when she got home.when she got home, the left side of her face became numb, she had a headache and burning eyes. The next day she still had a little numbness on the left side of her mouth. no problems since.
65 2021-01-11 fever, chills Chills with fever, Acute diarrhea
65 2021-01-11 fatigue, headache I had body aches, headaches, and just felt tired. I took Tylenol extra strength every 6 hours for a ... Read more
I had body aches, headaches, and just felt tired. I took Tylenol extra strength every 6 hours for a 24 hour period. After that I felt fine.
65 2021-01-11 chills, headache Joint pain/Her knee really hurts; Muscle pain; Headache; Chills; Her back hurts, especially at night... Read more
Joint pain/Her knee really hurts; Muscle pain; Headache; Chills; Her back hurts, especially at night/Her lower back hurts; Her neck is really bad; Her hands hurt; mild arthritis; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via an unspecified route of administration in left upper arm on 30Dec2020 15:20 at single dose for covid-19 immunization in hospital and vaccine was not administered at Military Facility. Medical history included car accident where she broke her neck, usually she is hot all the time, she is a health person and she went the whole year without a cold. There were no concomitant medications. Prior vaccinations included regular flu shot, but she thought it was longer than 4 weeks. There was no vaccines was administered on same date of Pfizer bnt162b2. The patient clarified the side effects she was experiencing as: joint pain, muscle pain, occasional headache, and chills that were coming in and out. The patient explained she got the vaccine on 30Dec2020. The patient started to have the joint pain 3-4 days after getting the vaccine in Jan2021. She stated it was still uncomfortable. Her back hurts, especially at night. It was like all the time, but more so at night. Her neck was really bad. Pretty much every place she had mild arthritis she hurt. She felt it mainly in her neck. She mentioned historically she was in a car accident where she broke her neck. The pain in her neck was almost to the point where she was when she was initially healing from the accident. Her hands hurt. Her lower back hurts. Her knee really hurts. It all hurt more than normal. The muscle pain started 3-4 days after she got the vaccine in Jan2021. The muscle pain was sporadic. She would feel it a little bit and then it went away and then she would feel it again. The headache started within the last 2-3 days in Jan2021. She thought it had gone away for the most part. She just got an occasional headache when her neck hurt a lot. It kind of went with the neck hurting. The chills started around 02Jan2021 or 03Jan2021. Usually she is hot all the time. However, lately she had been feeling chills. She was not sure if it was due to weather or if she was really having chills. This is unusual for her. She stated the chills was kind of the same or maybe a little better. She had a COVID test done on 26Dec2020 which was negative. She had to have the test done for pre-surgical reasons. The adverse events did not require a visit to emergency room or physician office. The outcome of joint pain/knee really hurt, muscle pain and chills were not resolved, outcome of rest events were unknown.
65 2021-01-11 headache, chills headache; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 65-year... Read more
headache; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, chills, and nausea on an unspecified date. The patient asked if she is going to get the same reaction on the second dose. The outcome of events was unknown. Information on the Lot/Batch number has been requested.
65 2021-01-11 chills non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous rep... Read more
non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 02Jan2021 07:30 at single dose for covid-19 immunization. The patient's medical history was none, and there were no concomitant medications. The first dose patient received on 02Jan2021 morning, and she just had symptoms she expected, she was sore at the injection site and she had some joint pain on 03Jan2021, but those disappeared on 04Jan2021. On 05Jan2021, she woke up and had non stop diarrhea with a little bit of nausea. Patient had not had a fever, but did feel chilled. Patient didn't think she ate anything bad. She was suspecting this may be a side effect of the vaccine. Patient didn't have a prescribing doctor. She got it at the hospital she worked at. She received it the 02Jan2021 7:30 am. Patient started the diarrhea on 05Jan2021 morning at 8:30. The nausea was on and off, but started this morning as well. Patient didn't take any ongoing medication. Outcome of events sore at the injection site and joint pain was recovered on 04Jan2021, outcome of event diarrhea was not recovered, and outcome of events nausea, and chills was recovering.
65 2021-01-11 headache received the vaccine on December 17th and tested positive for Covid on December 27th/COVID PCR (poly... Read more
received the vaccine on December 17th and tested positive for Covid on December 27th/COVID PCR (polymerase chain reaction) test: positive on 28Dec2020; received the vaccine on December 17th and tested positive for Covid on December 27th/COVID PCR (polymerase chain reaction) test: positive on 28Dec2020; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable nurse (patient) reported that a 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 17Dec2020 11:00 in left deltoid at single dose for covid-19 immunization. Medical history included thyroid cancer from an unknown date and unknown if ongoing, bilateral thyroidectomy in 2014. Family Medical History: Father died of lung cancer. Mother died of cardiac arrest in 1972. Concomitant medication included levothyroxine sodium (SYNTHROID) for bilateral thyroidectomy. The patient received the vaccine on 17Dec2020 and tested positive for covid on 27Dec2020. The adverse events resulted in emergency room visit. The patient underwent lab tests and procedures which included tested positive for COVID on 27Dec2020, COVID PCR (polymerase chain reaction) test: positive on 28Dec2020. Vaccination facility type was hospital. No additional vaccines administered on same date of Pfizer suspect. Received COVID Vaccine on 17Dec2020. Tested positive for COVID in emergency room on 27Dec2020. Tested positive on a COVID PCR test on 28Dec2020. Prior vaccinations within 4 weeks was none. Caller received the first dose of the COVID Vaccine. Tested positive for COVID on 27Dec2020. Is about to get the second dose of COVID Vaccine and would like to know if she should proceed or wait. Since quarantine, she has had no fever. Is slightly short of breath and has a headache. Works in COVID units in a hospital. Wants to make sure she can receive the second dose. Stated she had no adverse reaction to the COVID Vaccine unless an adverse reaction can occur two weeks after. Is attributing the shortness of breath and headache to testing positive for COVID. Shortness of breath and headache only occurred after testing positive for COVID. Reason she went to the hospital is because she lost her sense of smell. She got tested and was positive for COVID. Lost sense of smell, went to Emergency Room, and notified doctor of positive test the following day, 28Dec2020. Clarified she just went to the emergency department to get tested for COVID and then went home. Was called with positive results in an hour. Caller wanted to know when she should proceed with getting her second dose of Covid vaccine. She is supposed to receive her second dose tomorrow. She thought she was going to take second dose when I completely recovered. Caller asked if she waited until the 13th to receive second dose of Covid vaccine, would it be effective. She would feel more comfortable doing that. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 based on the known safety profile. However the short duration of 9 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
65 2021-01-12 fatigue 24 hr after vaccine developed body aches in shoulders, hip and back. Moderate to severe fatigue and... Read more
24 hr after vaccine developed body aches in shoulders, hip and back. Moderate to severe fatigue and sore left arm at site of injection. Symptoms remained for 36 -48 hrs. Took Tylenol for body aches , increased fluid intake and rested for 2 days. Completely resolved by day 3
65 2021-01-12 fatigue, chills, headache, fever Most extreme chills Fever 100 F Headache Neck ache Body aches Fatigue All lasted until about 6pm and... Read more
Most extreme chills Fever 100 F Headache Neck ache Body aches Fatigue All lasted until about 6pm and then patient was fine. Got Covid at work in March 2020
65 2021-01-12 fatigue, headache Slight sore arm at injection site, headaches, body aches, fatigue
65 2021-01-12 fever, chills chills, low grade fever, diarrhea
65 2021-01-13 lethargy, sweating, malaise 1/13/2021 at 3:11 pm EMT was alerted to client in observation area. Client was lethargic and compla... Read more
1/13/2021 at 3:11 pm EMT was alerted to client in observation area. Client was lethargic and complained of dizziness and feeling sick. Client brought to medic area. EKG and B/P and blood sugar taken. Client diaphoretic.
65 2021-01-13 body temperature increased, chills Awoke on 1/8/21, about 18 hours after injection with body aches and aching joints persisting for the... Read more
Awoke on 1/8/21, about 18 hours after injection with body aches and aching joints persisting for the rest of the day, taking ibuprofen every four hours. 1/9/21 I woke with moderate itching of scalp, body aches continue. Throughout the day I had large itching whelps at different places on my body. At 11:00am my temperature was 100.5, at which time I also had moderated chills for about an hour. I took ibuprofen and tylenol and benadryl at 4 hour intervals. after the chills stopped (about an hour) symptoms began to calm down. Sunday I woke with no symptoms at all.
65 2021-01-13 headache, fatigue, chills Fatigue,headache, chills lasting about 36 hours
65 2021-01-13 headache, fever Fever , body aches, shortness of breathe, headache
65 2021-01-14 chills, headache CHILLS, HEADACHE, MUSCLE PAIN
65 2021-01-14 fatigue, sweating, chills generalized body aches; chills; heart rate in 140s; diaphoretic; dizzy; fatigue; This is a spontaneo... Read more
generalized body aches; chills; heart rate in 140s; diaphoretic; dizzy; fatigue; This is a spontaneous report from a contactable healthcare professional. A 65-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration from 07Jan2021 13:30 to 07Jan2021 13:30 at a single dose for an unspecified indication. Medical history included covid (COVID prior vaccination: Yes). Concomitant medication included valacyclovir and vitamin d3. The patient previously took ampicillin, Keflex and metronidazole; the patient had allergies with all. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020. It was reported that 9-hours post second vaccine, the patient had generalized body aches, chills, 2 hours later Heart Rate in 140s, diaphoretic, chills and dizzy. HR normalized 6 hours later. Diaphoresis lasted 10 hours. No treatment was received for the events. The patient also reported to have extreme fatigue. The outcome of the event heart rate abnormal and diaphoretic was recovered on 08Jan2021 while recovering for the other events.
65 2021-01-15 fever Had fever of 102.3 deg F oral. Took 1000 mg of acetaminophen and fever broke. No further fevers occ... Read more
Had fever of 102.3 deg F oral. Took 1000 mg of acetaminophen and fever broke. No further fevers occurred. Also had muscle aches during fever.
65 2021-01-15 sweating, headache, chills chills, bodyache, headache, sweating
65 2021-01-16 fatigue, chills, fever Severe chills began at 10:30 pm; then fever spiked; slept fitfully and finally got up around 2 am to... Read more
Severe chills began at 10:30 pm; then fever spiked; slept fitfully and finally got up around 2 am to get a thermometer -while in bathroom the room started spinning and I fainted or passed out. I came to on the bathroom floor and managed to crawl back to the bed. There was confusion and the inability to understand what was going on. I remained in bed until the next morning when all symptoms abated except for some fatigue.
65 2021-01-16 malaise, chills, fever This AM developed malaise, fever, and chills
65 2021-01-17 body temperature increased 12 hours after receiving the second vaccine I developed a temp of 103 that lasted approximately 36 h... Read more
12 hours after receiving the second vaccine I developed a temp of 103 that lasted approximately 36 hours. I also developed a rash on my forearms 24 hours after the vaccine which lasted approximately 24 hours
65 2021-01-17 headache, fever Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccinatio... Read more
Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccination. States she had these same symptoms up to 3 days after vaccine but they resolved. She is also reporting onset of headache, joint pain yesterday (9 days post vaccine) and low grade temp today (10 days post vaccine).
65 2021-01-17 fever, lethargy Six days after having our first COVID-19 vaccine my husband and I started experiencing fever, aches,... Read more
Six days after having our first COVID-19 vaccine my husband and I started experiencing fever, aches, and lethargy. We notified our primary care facility. We were sent to get a test for COVID-19. We both tested positive. We need to know how this affects our second vaccine which is scheduled for January 27th. Please advise us.
65 2021-01-17 headache TOOK TYLENOL SINUS HEADACHE AT 2PM ON FRIDAY. WOKE UP FRIDAY AT MIDNIGHT WITH CHILLS, HEADACHE AND S... Read more
TOOK TYLENOL SINUS HEADACHE AT 2PM ON FRIDAY. WOKE UP FRIDAY AT MIDNIGHT WITH CHILLS, HEADACHE AND SHAKING. TOOK TYLENOL SINUS. REPEATED TYLENOL SINUS EVERY 4 HRS FOR HEADACHE. ON SAT AND SUNDAY WAS WEAK--MONDAY FELT BETTER.
65 2021-01-17 respiratory tract congestion, headache chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous repo... Read more
chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiration date not reported), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Medical history included 'Blood pressure'. Concomitant medication included doxorubicin hydrochloride (LIPISOL) for blood pressure. The patient reported that on 08Jan2021 (Friday), she had the COVID vaccine. On 09Jan2021 (Saturday), her arm hurt, she had body aches, and weakness. She also had a headache Saturday night. On 10Jan2021, she started getting chest congestion and her throat was hurting. When she was spitting out it felt like her throat was scratchy. Patient further reported that her arm does not hurt now. It still bothers her a little if she touches it, but doesn't if she doesn't touch it. Patient also reported that she does not have too much body aches now. She had a good dinner and took two of the 600mg Ibuprofen. It helped her. It still hurts a little. Patient reported that her weakness feels a little better. No fever and she has been checking her temperature. Patient clarified that her throat wasn't bothering her last night, but today it was bothering her. It was the bottom of her throat. She was supposed to go back on the 29th to get the other part. The patient was recovering from arm hurt, body aches, and weakness; has not recovered from chest congestion; and unknown outcome for the remaining events.
65 2021-01-18 chills Appendicitis; Vomiting; Nausea; Chills; This is a spontaneous report from a contactable consumer. A... Read more
Appendicitis; Vomiting; Nausea; Chills; This is a spontaneous report from a contactable consumer. A consumer reported that her 65-year-old mother received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Unknown), into the arm at single dose on 31Dec2020 for COVID-19 immunization. The patient did not have any medical history and did not receive any concomitant products. On 31Dec2020 the same evening of vaccination, the patient experienced vomiting, nausea and chills that were considered flu like. On 03Jan2021 or 04Jan2021 her appendix ruptured. She entered emergency room on 07Jan2021 and was diagnosed with appendicitis. She was admitted to hospital on 07Jan2021. She has been given hospital care for past four days. She will have surgery in 6 weeks to repair and right now they are cleaning ruptured area. Her care team is wondering if she should get second dosage. The patient is currently hospitalized. The patient recovered from the event vomiting on 31Dec2020, recovered from the events Nausea and Chills on 07Jan2021 and was Recovering from the appendicitis. Information on the lot/batch number has been requested.
65 2021-01-18 chills, fatigue, headache, fever Fever, chills, nausea, h/a, fatigue, vomiting lasting > 48*
65 2021-01-18 chills, fever, malaise Received second vaccine on 1/5/21 and on 1/6/21 started having chills, malaise and 102.3F fever. Sy... Read more
Received second vaccine on 1/5/21 and on 1/6/21 started having chills, malaise and 102.3F fever. Symptoms persisted appx. 24 hours and she took two days off work. She has now returned to normal and back to work.
65 2021-01-18 fatigue, headache, runny nose Runny nose, diarrhea, headache, fatigue, abd pain.
65 2021-01-18 chills, headache, fever was burning up; Sore arm; Throbbing headache; I was hot, I was cold; Fever; Chills; This is a sponta... Read more
was burning up; Sore arm; Throbbing headache; I was hot, I was cold; Fever; Chills; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 07Jan2021, at single dose, for COVID-19 immunization, in the hospital. Medical history included blood pressure high and high cholesterol. The patient reported "I just got my second Pfizer Vaccine (clarified as BioNTech Covid 19 vaccine) yesterday (07Jan2021) and I just wanted to call to report the side effects that I have because they told me you should specially after the second one. And I have had fever, headache, and chills. So, I just wanted to report this". When asked about the event start date, the patient stated, "I went to sleep, I got the shot yesterday morning on early (07Jan2021). And then I was fine except for the sore arm. And then I woke up in the night. I fell asleep fine; I woke up through the midnight and it was burning up. So, I took my temperature. So, I'd say about 3 am (08Jan2021)". When asked if the patient was still experiencing the events, the patient stated, "Little bit because I had also throbbing headache and I was hot, I was cold. I did take Tylenol (treatment) and I did think that it started to help a little bit. Because I did got, my fever has gone down." The outcome of the events was recovering.
65 2021-01-19 chills, fever, fatigue, headache Fever of 101.5 Headache Pain at injection site Body aches Chills, extreme fatigue
65 2021-01-19 fatigue, fever, headache fever, myalgia, rash, headache, nausea, fatigue
65 2021-01-19 chills, headache, fatigue, fever passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe head... Read more
passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP. A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 07Jan2021 11:00 at single dose for Covid-19 immunisation . Medical history included rubber sensitivity (Latex). The patient's concomitant medications were not reported. On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out with outcome of recovered , dizzy with outcome of recovered , hit the ground with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills with outcome of recovered , tired with outcome of recovered , severe headache on with outcome of recovered , vomiting twice with outcome of recovered , cold with outcome of recovered. The reporter stated the patient attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out dizzy and falling down and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-01-20 sweating In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea a... Read more
In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea and eventual vomiting. This lasted for a long period of time, I asked to go to ER because I was so alarmed. I felt great all day prior to injection. I had been at work as a nurse with Mobile County Public School System, until I came to get vaccination .
65 2021-01-20 headache, fever, chills Severe chills, fever, lower stomach pain, headache, injection site pain
65 2021-01-20 runny nose Swelling at injection site, swelling of hands, next day runny nose
65 2021-01-20 throat irritation generalized rash, tickle in throat sensation
65 2021-01-21 fatigue, headache ACHES/ HEADACHE/ FATIGUE/ NAUSEA. LASTED UNTIL 1/14 AFTERNOON. TOOK ADVIL AND REST
65 2021-01-21 throat irritation Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; ... Read more
Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; feeling of swelling and burning in throat; slight difficulty swallowing; hoarseness; pruritus
65 2021-01-21 fever, sweating, headache, fatigue Approx 5.5 days after receiving her first COVID-19 vaccine, reporter developed a low-grade fever of ... Read more
Approx 5.5 days after receiving her first COVID-19 vaccine, reporter developed a low-grade fever of 99.1-99.4F, headache, light nausea, and fatigue. Noted profuse sweating upon waking on 1/21/21.
65 2021-01-21 chills Chills for 1.5 hours beginning approx 2 hours following injection
65 2021-01-21 fever, chills First: headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second:... Read more
First: headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second: chills and low grade temps x 10 days. Joint pain x 10 days. Itching on day 13. Intermittent headaches and brain fog x 10 days.
65 2021-01-21 headache, fatigue, fever, chills First: headache x 6 days . Pruititis day 10 which incurred eruption on finger. Generalized muscle... Read more
First: headache x 6 days . Pruititis day 10 which incurred eruption on finger. Generalized muscle and joint pain x 7 days with low grade temp and chills. Fatigue Second dose: low grade temp and chills and body aches x 10 days. Fatigue. Brain fog
65 2021-01-21 influenza like illness, chills, headache, fatigue Flu like symptoms Major chills could not get warm Fatigue had to leave work No fever Headache Resolv... Read more
Flu like symptoms Major chills could not get warm Fatigue had to leave work No fever Headache Resolved by 11:00am 01/22/2020 No adverse events with first dose
65 2021-01-21 sweating Has a flush feeling over entire body, then broke out in a sweat. Felt prickly (pins and needles] in... Read more
Has a flush feeling over entire body, then broke out in a sweat. Felt prickly (pins and needles] in my arms on and off all day.
65 2021-01-21 fatigue, sleepiness Monitored for 15 minutes at facility. Left and came home. Within 1hour I was lightheaded and dizzy. ... Read more
Monitored for 15 minutes at facility. Left and came home. Within 1hour I was lightheaded and dizzy. Mental fog and exhaustion. Symptoms lasted through. 1/21/2021. Today mental fog lifted, lightheaded but not dizzy. Not as sleepy. Seems to be lessening as day goes on (1/22/2021)
65 2021-01-21 fatigue, headache Nausea on 1/19. Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigu... Read more
Nausea on 1/19. Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigue,. Got up on 1/21 still slightly achy but headache all day. Slept a great deal and took advil.
65 2021-01-21 chills, headache, fever One week later, fever of 102.8, chills, headache, body aches lasting 2 days
65 2021-01-21 fatigue Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) ap... Read more
Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) approximately 5 minutes after receiving the 2nd dose of the COVID vaccine. The patient was taken to the emergency department for further workup. In the ED, the patient was given acetaminophen and ondansetron with resolution of all symptoms except generalized weakness and fatigue. Workup in the ED was negative, and the patient was discharged home.
65 2021-01-21 fever fever 4 days later and diarrhea
65 2021-01-22 fever, chills After I got home from work on Friday 1/22 I developed a fever of 100.8 with chills.
65 2021-01-22 throat irritation Patient received 2nd dose of Pfizer COVID vaccine (Lot# EL9261). Within the 15 min wait time the pat... Read more
Patient received 2nd dose of Pfizer COVID vaccine (Lot# EL9261). Within the 15 min wait time the patient reported swelling of tongue. ( 1040 am) Immediately reported and responded. Patient alert and verbalized she felt "ok". Patient then reported increase in symptoms and was treated with 100 mg of Benadryl IM left deltoid. B/P 110/60, HR 77 and Pulse Ox 98%. Patient then reported a "tickle in the back of my throat" Patient immediately treated with Epinephrine 0.5 mg IM right thigh @ 1059. B/P 137/65, HR 73, Pulse OX 99% EMS arrived and patient transported.
65 2021-01-22 headache Severe nausea, syncope, headache
65 2021-01-22 throat irritation Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and... Read more
Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and outside, throat tightening, lungs heavy , not, and tightening. Body heavy. Mind disconnected. Happened with in 5 minutes of injection.
65 2021-01-23 fever Reported fever of 101 degrees F yesterday with joint pains and today diarrhea with continued joint p... Read more
Reported fever of 101 degrees F yesterday with joint pains and today diarrhea with continued joint pains. Has had BM five times already. Temp decreased to 100 degrees F. along with diarrhea and joint point
65 2021-01-24 throat irritation At 1000, RRT was called in the post-vaccine recovery area for a 65 y/o female who complained of itch... Read more
At 1000, RRT was called in the post-vaccine recovery area for a 65 y/o female who complained of itchy throat and swollen upper lip. 2 RNs responded with stethoscope, pulse ox, and emergency kit. Head-to-toe assessment completed. Assessment WNL. Vitals: 02: 96%, HR: 65, manual BP: 180/100. Client took Losartan 100 mg in the AM, only. Fire Chief on site, activated 911 response. Paramedics arrived and completed their work-up. Vitals stable, client AA0x4, assessment continues to WNL. Client speaking in full sentences with no labored breathing. 2 RNs determined to have client wait in recovery area for 15 more minutes. EMS did not transport client to hospital. After 15-minute period, client was stable and left AMA.
65 2021-01-24 headache At 53 hours after injection experienced piercing headache throughout different parts of head, face ... Read more
At 53 hours after injection experienced piercing headache throughout different parts of head, face and neck accompanied by nausea though no vomiting or fever. Tylenol did not touch it. Slept on and off. Lasted 24 hours and then disappeared.
65 2021-01-24 headache BY the evening I developed a headache and had serve pain for about 5 days in the middle of my back.... Read more
BY the evening I developed a headache and had serve pain for about 5 days in the middle of my back. After that my nose got stocked up and I ended up getting Covid.
65 2021-01-24 fatigue, chills Diarrhea Chills Muscle aches Extreme fatigue
65 2021-01-24 fever, chills, fatigue, headache I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, e... Read more
I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, exhaustion for 4 days. shot given on Wednesday and not able to shower or get up till Sunday Second shot symptoms more severe. Headache, sick to my stomach vomited, and exhaustion same thing shot given on Wednesday and not able to get up till Sunday. First 24 hours of the second shot I was so weak I good not get up even to get a drink.
65 2021-01-24 chills, headache Raid heart beat headache chills and extremely high blood pressure
65 2021-01-25 headache, respiratory tract congestion, chills About 15 hours later headaches, chills, congestion, weakness, body aches
65 2021-01-25 fever, fatigue DAY AFTER VACCINATION, HAD LOW GRADE FEVER, FATIGUE, AND WEAKNESS
65 2021-01-25 fatigue, headache, fever First night awoke 3am with muscle pain and fever. By morning also had sinus congestion/headache/eye ... Read more
First night awoke 3am with muscle pain and fever. By morning also had sinus congestion/headache/eye ache; fatigue. Temp continue to rise throughout day, reaching 100.8 by 5:30pm. All symptoms began to dissipate by 9pm, awakening normal by morning..
65 2021-01-25 chills, headache, fever, headache, fever, chills HA, chills, fever, body aches, swelling at injection site. Symptoms resolved after 48 hrs
65 2021-01-25 headache Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nausea... Read more
Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) intramuscular in the right arm on 11Jan2021 07:30 AM at a single dose for Covid vaccine. Medical history included high BP. The patient had no known allergies. Concomitant medications included lisinopril, colecalciferol (VITAMIN D), vitamin B complex (B COMPLEX), calcium, and cetirizine hydrochloride (ZYRTEC) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient experienced headache not too bad but hot nauseated 24 hours after injection on 12Jan2021 08:00 AM. Treatment was not received for the events. The patient had no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the events was not recovered.
65 2021-01-25 headache, fever, chills Low fever, Chills, Body aches, Sore arm, Mild head ach
65 2021-01-26 headache 1/20/21: Headache; slight nausea with flip-flop stomach feeling; no appetite; sore arm injection are... Read more
1/20/21: Headache; slight nausea with flip-flop stomach feeling; no appetite; sore arm injection area 1/21/21: Lingering headache but only slight; sore arm injection area 1/22/21: Lingering sore arm but dramatically decreased
65 2021-01-26 chills, headache I had chills, body aches and a headache. I also had pain at the injection site. I went to bed and ... Read more
I had chills, body aches and a headache. I also had pain at the injection site. I went to bed and when I woke up the next day, I only had a slight headache which was gone by noon.
65 2021-01-26 malaise When I signed up for the vaccine, the website said that i was at high risk for the vaccine and would... Read more
When I signed up for the vaccine, the website said that i was at high risk for the vaccine and would need to wait 15-30 minutes after the injection. I checked with doctor re: this warning and she felt the vaccine was still beneficial but to do my research and make a decision. I received the vaccine at the Center. I sat down as instructed. 5 minutes later, something felt off and I removed my protective visor. A paramedic came over about a minute later and asked if i was ok. I said that i didn't feel well. He said that he was going to get a chair with wheels for me and at that time i must have passed out. The next thing that i remember was waking up laying on the floor. My husband said that there were 4 paramedics in attendance. The primary paramedic was telling me that my BP was 72/60. An ekg was being run, an iv inserted and run full force. they checked my blood sugar which was fine. The primary paramedic kept talking to me to check my level of consciousness. I was there for quite a while. Not sure who the paramedics checked with, but they decided that i needed to go via ambulance to the hospital. The paramedics were very concerned that the ambulance go to the back door to pick me up so others getting the vaccine would not be frightened. I was transported to Medical Center for further evaluation. I was there for a few hours and my labwork was normal. EKG and chest xray were completed as well as cardiac monitoring. I called doctor's office the next morning to notify her of the event. It was very scary!!!
65 2021-01-26 fever, chills, headache slight headache; low grade fever and chills for approx 10 hours post injection; low grade fever and ... Read more
slight headache; low grade fever and chills for approx 10 hours post injection; low grade fever and chills for approx 10 hours post injection; This is a spontaneous report from a contactable other healthcare professional (HCP). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscular on 08Jan2021 18:00 (reported as 06:00 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. There were no other medical history. No known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. Facility type vaccine was hospital. No COVID prior vaccination. The patient experienced slight headache, low grade fever and chills for approximately 10 hours post injection on 09Jan2021 02:00 PM. No treatment for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.
65 2021-01-27 fever, headache Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas... Read more
Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas; Fever; Tightness in jaw; Sore arm and muscles; Sore arm and muscles; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 12Jan2021 08:40 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness in jaw within one hour after vaccination and noticed on her way home, sore arm and muscles on 12Jan2021, fever last night (13Jan2021). Her body was aching from her groin and going down, especially in both thigh areas on 13Jan2021. It woke her up. She didn't take anything for it. She laid there until she went back to sleep. It was gone now. The patient also experienced a headache on an unspecified date and chapped lips on 14Jan2021. The outcome of the events chapped lips and headache was unknown, tightness in jaw was not recovered, body is aching from her groin and going down, especially in both thigh areas were recovered while other events were recovering.
65 2021-01-27 headache I ached and had a headache, very bad body aches. It lasted till that Sunday. I called hospital numbe... Read more
I ached and had a headache, very bad body aches. It lasted till that Sunday. I called hospital number and they set me up with an NP and to get Covid tested. Test came back negative. I had Covid back in June, and Covid is much worse than the vaccine.
65 2021-01-27 fever I have had all the side effects listed as well a being febrile for 15 hours with alleviation of feve... Read more
I have had all the side effects listed as well a being febrile for 15 hours with alleviation of fever or symptoms yet. Additional symptoms are enlarged lymph nodes and infrequent but sharp shooting pains in the ear and lymph regions. At the time of this report, symptoms are ongoing.
65 2021-01-27 fatigue, headache Nausea, Continuous headache, Exhaustion for THREE days
65 2021-01-27 fever, headache Sore arm. body aches, low grade fever, headache,
65 2021-01-27 fever low grade fever, body aches, swollen lymph node under armpit
65 2021-01-28 headache 136/78, SPO2 98% on RA, 56 HR, Patient complains of HA behind right ear. Upon questioning she states... Read more
136/78, SPO2 98% on RA, 56 HR, Patient complains of HA behind right ear. Upon questioning she states that she nhas been crying all day due to a family death/burial today. Encouraged to hydrate, Therapuetic listening by RN initiated. Patient states that she is feeling better after 15 minutes. Vitals remain stable, Instructed to call 911 w/ any emergent symptoms, pt verbalized understanding and signed document.
65 2021-01-28 fatigue Starting the next night my feet wer freezing when trying to lie down at night, could not get them wa... Read more
Starting the next night my feet wer freezing when trying to lie down at night, could not get them warm unless wrapped in a blanket which is not normal for me, still ongoing but less intensity today 1-29 Ongoing fatigue and having to nap daily and if working go home and going to be early and sleeping about 10-11 hours a night, again not normal Improving daily but still ongoing
65 2021-01-29 fatigue About 26 hours after receiving the Pfizer Covid Vaccine, I experienced about half an hour of extreme... Read more
About 26 hours after receiving the Pfizer Covid Vaccine, I experienced about half an hour of extreme dizziness, starting about 6:00 pm. It lasted so long that I decided to just go to bed. I have never experienced such intense dizziness before. Also, I felt tired the next day, and just stayed home and rested. So far, I have not had any more dizzy spells.
65 2021-01-29 headache developed numbness/tingling of tongue, headache and also pain across chest, as well as high BP and H... Read more
developed numbness/tingling of tongue, headache and also pain across chest, as well as high BP and HR. Given water, benadryl 50 mg IM with improvement of everything except chest pain. Sent to CSMC ER for further evaluation.
65 2021-01-29 throat irritation numb lips with tightness and itching in throat, flushing
65 2021-01-31 cough, headache Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing th... Read more
Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing that evening, headache, sore arm. Took Tylenol.
65 2021-01-31 fatigue, malaise Paresthesias of left hand, general malaise, fatigue, ? HTN urgency ? however missed HTN med doses at... Read more
Paresthesias of left hand, general malaise, fatigue, ? HTN urgency ? however missed HTN med doses at the time of evaluation
65 2021-02-01 dehydration, lethargy, chills, fever Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1... Read more
Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1/23 she had defervesed to normal temp. Afternoon of 1/23/21 temp 101.4, 1/24/21 fever of 103 and 101. On 1/25/21 the nurses called the doctor and said that she was lethargic. Dr. found her to be hypotensive, lethargic, tacchycardic, They sent her to the ER. She also had during that day they found her with neck pain with movement, chills and fever. From 1/25-today she is still admitted to the hospital. They found her to have staph aureus sepsis - source unknown, encephalopathy related to sepsis, they did rule out meningitis, hyponatremia, UTI with E-coli and some staph, urinary retention, rhabdomyalisis with acute kidney injury and dehydration. They are treating her with antibiotics, getting better but still hospitalized.
65 2021-02-01 headache, fatigue, malaise hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in h... Read more
hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-02-01 fatigue, headache headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer report... Read more
headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient (not pregnant), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration, on left arm on 16Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included Diverticulosis, hypothyroid, osteoarthritis, vitiligo, psoriasis, anxiety/depression, known allergies: Iodine, sulfa, bivalve shellfish, garlic, onions. Concomitant medications included first dose of pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 23Dec2020 on left arm, celecoxib (CELEBREX), sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL). The patient experienced fatigue, sore arm the day after vaccine was administered on 17Jan2021. Two days after administration on 18Jan2021, patient experienced fatigue, headache, nausea. No treatment received for all events. The outcome of the events were resolving.
65 2021-02-02 fatigue nausea, diarrhea, dizziness, aches & pains all over body, feeling weird, tired, can't get up, all l... Read more
nausea, diarrhea, dizziness, aches & pains all over body, feeling weird, tired, can't get up, all lasting 3 days
65 2021-02-03 fatigue, headache, malaise, chills After receiving second dose of Phizer COVID19 Vaccine I became ill with shaking chills, muscle aches... Read more
After receiving second dose of Phizer COVID19 Vaccine I became ill with shaking chills, muscle aches, headaches and fatigue. Event started at home the day after receiving vaccine.
65 2021-02-03 headache, fever, chills, fatigue Around 1:00 am on the 2/3/21 I got a fever and was shivering. When I got up I was very weak and ti... Read more
Around 1:00 am on the 2/3/21 I got a fever and was shivering. When I got up I was very weak and tired. I started with a headache in the evening of 2/2/21
65 2021-02-03 headache Bad headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old fema... Read more
Bad headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 first dose on 18Jan2021 15:30 on left arm at single dose for COVID-19 immunization at Parking lot of a big stadium. Medical history included stressed and headache, both from 18Jan2021 before vaccine and medication to help sleep. Concomitant medication included ongoing clonazepam (KLONOPIN) tablet at 2mg pill at night to help sleep. Vaccine not Administered at Military Facility. No History of all previous immunizations with the Pfizer Vaccine considered as suspect. No Additional Vaccines Administered on Same Date. No Prior Vaccinations within 4 weeks. She is calling because she got the vaccine today and she has a bad headache. She mentioned she knows headache is a possible side effect. However, she is calling to see what she can take or what she cannot take for the headache. She stated before getting the vaccine she was stressed and had a headache that had started today, 18Jan2021, before she got the vaccine. She mentioned she was waiting 3.5 to 4 hours before getting the shot and that is when the headache started. However, after getting the vaccine it has gotten worse and it is to the point where she wants to place an icepack on her face. Stated it could be situational. She knows she was in the car for at least 5 hours. She also mentioned the paperwork we provide with a list of symptoms should also have listed what medications she can or cannot take. She finds it troubling that we do not have the listed on the paperwork. We have headache could be a possible symptom, but no information on what can be taken for symptoms. She also mentioned she needed her reading glasses to attempt to read the patient card provided that list the lot number and details regarding date for next dose. She then stated after looking at the card it is impossible to read. She cannot read the person's handwriting. The lot number is so messy. She believes it is: L2 7 or 8, 922 or 422, something like that, she cannot really tell the handwriting is so messy. The event not require a visit to Emergency Room or Physician's Office. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
65 2021-02-03 fatigue Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a c... Read more
Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ 1685), via an unspecified route of administration in the left arm on 20Dec2020 08:00 at a single dose for covid-19 immunization. Medical history included prediabetes, spinal stenosis of right back, allergies in penicillin, sulfa and yellow jacket venom. Concomitant medication included gabapentin, metformin, paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc and vitamins. On 20Dec2020 20:00, 12 hours after vaccine administration, the patient experienced blurred vision, fatigue, dizziness, tachycardia and arm soreness. The patient did not receive treatment for the events. The patient had not tested positive for COVID post vaccination. The outcome of the events was recovered on unspecified date.
65 2021-02-03 headache, chills Chills, body aches, severe headache
65 2021-02-03 cough, malaise Got tested and came positive after receiving first vaccine; Got tested and came positive after recei... Read more
Got tested and came positive after receiving first vaccine; Got tested and came positive after receiving first vaccine; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events in two patients. This is the first of two reports. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included vitamins nos. It was reported that both the patient and her husband received the Pfizer Vaccine on 10Jan2021; and they had reaction to it. They both both had bad arm swelling and pain. Her was worst she couldn't even lift or move her arm. At first, they just thought it was a reaction as they read reactions could be and then she started to get small cough but by Friday, her husband went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday, they both went and got tested, they did the rapid and they did what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. So, she thought they need to know that they got sick and it was after the vaccine. The patient needed to ask a question as they were supposed to go for their second vaccine on 31Jan2021 and do they do it even though they got sick. They knew they were claiming that they can't get sick because of the vaccine but it's very ironic that they did get this. They had been following CBC guidelines, both her husband and the patient because they are older and they wear mask all the time and they did everything they needed to and they could not understand how they got this. The patient underwent lab tests and procedures which included Rapid and PCR: positive in Jan2021. Therapeutic measures were taken as a result of "bad arm swelling and pain; worst she couldn't even lift or move her arm" which included treatment with Tylenol. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092094 same reporter and drug, similar events in a different patient
65 2021-02-03 headache headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female p... Read more
headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:15 AM at single dose in left arm for COVID-19 immunisation. The most recent COVID-19 vaccine was administered at workplace clinic. Patient age at vaccination is 65 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 06:15 PM, at single dose in right arm. Medical history included high blood pressure and high cholesterol. The patient has no allergies to medications, food, or other products/known allergies. The patient received unspecified concomitant medications. On 20Jan2021 on 01:00 PM the patient experienced a headache after second dose, it started about 24 hours after the 2nd dose. Still have it on day 2, but is not severe. Using generic Tylenol to treat it. The event was reported as non serious. The event was resolving. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 SR008138-Salivary, SARS-COV-2 COVID-19 test on 14Jan2021 with negative result.
65 2021-02-04 headache, fatigue At 11:30 pm, I experienced body aches ( neck, back, legs, and head) and insomnia. 3:00 am I took Ad... Read more
At 11:30 pm, I experienced body aches ( neck, back, legs, and head) and insomnia. 3:00 am I took Advil. Woke up a bit better. Just headache remained. Totally exhausted though. Took 2 naps. Went to sleep at 9:30 pm-6:00, second night. Today, day 3, so far so good
65 2021-02-04 headache, influenza like illness Body aches, joint pain, muscle ache, headache, flu like symptoms.
65 2021-02-04 fever Injection site very sore; arm swollen; Feverish; This is a spontaneous report from a contactable con... Read more
Injection site very sore; arm swollen; Feverish; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the left arm, on 21Jan2021 at 10:15 (at the age of 65-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFIB), shellfish allergy, allergy to pain medications, cancer, diabetes, high blood pressure, and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks of vaccination, included amlodipine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), and esomeprazole magnesium (ESOMEPRA). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm swollen and feverish on 21Jan2021 at 19:30 and injection site very sore on 23Jan2021. The events were reported as non-serious. It was reported that the injection site was very sore on the third day. Therapeutic measures were taken as a result of the events, which included paracetamol (TYLENOL) and icing arm. The clinical outcome of injection site very sore, arm swollen, and feverish was not recovered.
65 2021-02-04 throat pain, chills Light headed and mild heart arrhythmia (fast beat). After 10 days, chills, joint pain and sore thro... Read more
Light headed and mild heart arrhythmia (fast beat). After 10 days, chills, joint pain and sore throat
65 2021-02-04 chills Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shor... Read more
Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shortness of breath with symptoms worsening as time went on. Pt remained afebrile. Pt presented to the ED and was diagnosed with a Pulmonary Embolism.
65 2021-02-04 chills, fever a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 ... Read more
a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 hrs; temp of 100.6; body aches; nausea; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3302), via an unspecified route of administration in the left arm on 21Jan2021, at 08:00 a single dose for covid-19 immunization. Medical history included breast cancer stage one from Oct2019. There were no allergies to medications, food, or other products. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), benazepril (MANUFACTURER UNKNOWN). The patient experienced the following event on 21Jan2021, at 03:00: a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 21Jan2021. Details were as follows: a few hours after injection, the patient noted that her arm was unusually sore past elbow chills that lasted for about six hours. Temp of 100.6 body aches nausea. It was reported that treatment was not received for the events; however she used a heating pad to relieve the pain. The events were non-serious. No diagnosis of COVID-19 prior to vaccination was noted. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events, a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea was recovered in Jan2021.
65 2021-02-04 headache body ached so badly that felt like a truck ran over; severe headache; This is a spontaneous report f... Read more
body ached so badly that felt like a truck ran over; severe headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 20Jan2021 at 09:45 in the left arm at a single dose for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications included trazodone, escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN), and raloxifene hydrochloride (EVISTA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021 at 09:45, the patient's body ached so badly that felt like a truck ran over and had severe headache. The patient had a physician office visit but did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
65 2021-02-04 fatigue fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous... Read more
fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received second dose of bnt162b2 (BNT162B2, LOT: EL 3248), via an unspecified route of administration from on 10Jan2021 10:30 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history included Prediabetes, spinal stenosis of right back, right hip pain, known allergies: Penicillin, sulfa, yellow jacket venom. No pregnant. The patient had no covid-prior-vaccination. The patient Historical Vaccine included COVID 19 for covid-19 immunisation at 65 years old, product=COVID 19, brand=PfizerBioN Tech, lot number=EJ 1685, administration date=20Dec2020, administration time=08:00 AM, vaccine location=Left arm; and After 12 hours (08:00 PM) experienced Blurred vision, fatigue , dizziness, tachycardia, arm soreness, after first vaccine 20Dec2020. Concomitant medication included gabapentin (GABAPENTIN), metformin (METFORMIN), paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc (ZINC). The patient experienced fatigue and arm soreness, and flair up of right hip pain after had received a epidural right hip block 5 days before 2nd injection since Jan2021. No treatment received. The event recovered in Jan2021. No covid-tested-post-vaccination.
65 2021-02-04 headache, fever fever, headache, bp 155/79 (usdually in 110's 120's/ baseline), and nausea. Caller wanted to know i... Read more
fever, headache, bp 155/79 (usdually in 110's 120's/ baseline), and nausea. Caller wanted to know if any interaction with APAP. Advised no interaction between Pfizer covid Vaccine and APAP, increase fluid intake as well, PIC will call back to f/u at later time.
65 2021-02-04 nasal congestion immunocompromised patient; immunocompromised patient; tested positive for COVID/nasal congestion; te... Read more
immunocompromised patient; immunocompromised patient; tested positive for COVID/nasal congestion; tested positive for COVID/nasal congestion; This is a spontaneous report from a contactable physician. A 65-year-old female patient (nurse) received bnt162b2 (Pfizer BioNTech COVID 19 vaccine), via an unspecified route of administration, the first dose on an unspecified date and the second dose on 14Jan2021, at single dose for covid-19 immunisation. The patient's medical history included immunocompromised. Concomitant medications were not reported. The immunocompromised patient received her second dose of Pfizer vaccine on 14Jan2021. On 20Jan2021, she developed nasal congestion and her son became sick the same day. Both tested positive for COVID. The physician asked would you consider giving the monoclonal ab to her? Physician knew the expectation was mild disease not severe but would you consider giving her the monoclonal? Outcome of the events was unknown. Information about lot and batch number had been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for COVID".
65 2021-02-05 fatigue, headache Evening following injection and next day: Mild headache was treated with acetaminophen. Slightly ... Read more
Evening following injection and next day: Mild headache was treated with acetaminophen. Slightly chilled. Next day: fatiqued.
65 2021-02-05 fever Sore arm at injection Fever of 102
65 2021-02-05 fever, chills, fatigue, lethargy Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued ... Read more
Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued until evening but were not as bad in afternoon. Low grade fever, migraine and nausea began around 2:00. Woke up with migraine at 6:30 am on February 6 which has subsided since taking sumatritam. Some fatigue and lethargy this morning but ok otherwise
65 2021-02-05 malaise, chills Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection giv... Read more
Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection given and a wave of pain and nausea and malaise overwhelmed me. I passed completely out still lying in bed (so out that I wet myself in bed) and gradually came to, still feeling horrible. Got up, changed clothes, and major chills when I returned to bed. Around 6am I felt nauseous, got up to vomit, but instead passed completely out on the bathroom floor for about 15 minutes. Remainder of day I felt very stiff, low energy and slightly woozy. By afternoon, energy was returning (I vacuumed the house). Minimal pain in arm this time compared to previous.
65 2021-02-06 headache Diarrhea 02/04/21;Headaches 02/04/22;Headaches 02/05/21;Headaches 02/06/21
65 2021-02-07 headache, throat irritation Headache; scratchy throat; This is a spontaneous report from a contactable consumer. A 65-year-old f... Read more
Headache; scratchy throat; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 15Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included blood pressure high, thyroid disorder and mental health disorder. Concomitant medication included took one medication for high blood pressure and a thyroid medication, both of those have been diagnosed quite a while and she had been on those medications a while. Patient was also on a mental health medication as well. Patient had a headache Tuesday (19Jan2021) or Wednesday (20Jan2021) this week. Patient also had a really scratchy throat. She didn't know if that was related to bnt162b2 or not. Treatment included ibuprofen (ADVIL 200mg, lot: R88356, expiration date: May2023). Patient took two 200mg, no more than every 4 hours or something, then clarified that patient took a couple at nighttime. Headache hadn't gotten worse. It was not as bad today (22Jan2021). It seemed to be subsiding. Outcome of headache was resolving. Outcome of scratchy throat was unknown.
65 2021-02-07 headache feeling like I had the flu without the high fever; had a very bad headache; soreness in the arm wher... Read more
feeling like I had the flu without the high fever; had a very bad headache; soreness in the arm where I received the shot; This is a spontaneous report from a contactable consumer reported for self. This 65-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL8982) at single dose in right arm on 20Jan2021 at 10:30 AM for COVID-19 immunization. Medical history included hypothyroidism. Allergies to medications, food, or other products were unknown. Concomitant medications included duloxetine; levothyroxine; montelukast; trazodone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient felt fine the day she received the vaccine, with only soreness in the arm where she received the shot. The next day at 11:00 AM, she started feeling like she had the flu without the high fever. The worse symptom was that she had a very bad headache. These symptoms were continuing 48 hours after the vaccine was administered. She was generally very healthy, had a very active life, and didn't get headaches. She was rarely sick. She just didn't seem to be feeling any better. Seriousness was no: not results in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. There was no treatment received for the adverse events. The adverse events was not resolved.
65 2021-02-08 headache, chills, malaise I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horr... Read more
I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horrible body pain. No temp. I missed 6 days of work I was so sick.
65 2021-02-08 malaise, headache, fatigue, chills She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energ... Read more
She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
65 2021-02-08 headache my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like ... Read more
my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like a deep wide black spot and it is hard; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included amlodipine, metformin and propranolol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization and experienced severe headache and diarrhea. On 13Jan2021, the patient reported that: "my body collapsed, I had a pulmonary embolism. I had to go to the hospital in ambulance. When I was there, they find out that I have clot in my lung. I was in an intensive care for 2 days or 3 days and about 5 days in the hospital (from 13Jan2021 to 17Jan2021). I have behind my knee like a deep wide black spot and it is hard, my body did not have anything like that". Therapeutic measures were taken as a result of event pulmonary embolism/ clot in lung and included treatment with "some medications", one of which ELIQUIS. The patient outcome of pulmonary embolism and "clot in lung" was recovered on an unspecified date and of deep wide black spot was unknown. The information on the batch number has been requested.
65 2021-02-09 headache Diarrhea; With the first one I had was severe headache; This is a spontaneous report from a contacta... Read more
Diarrhea; With the first one I had was severe headache; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 18Dec2020 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included amlodipine (AMLODIPINE), lansoprazole (LANSOPRAZOLE), metformin (METFORMIN) and propranolol (PROPRANOLOL). The consumer stated, "I had this number to call. After I took the vaccine, the Pfizer vaccine on 18Dec2020, with the first one I had was severe headache on 19Dec2020 and I had some diarrhea on an unspecified date too. So, the headache started like from Saturday night sometimes until Monday and then after that it goes away, it went slowly but it goes away, severely, it was for two days." The outcome of the event headache was recovered on 21Dec2020 while the other event was unknown. Information about batch/lot number has been requested.
65 2021-02-09 headache, fever Extreme headache, nausa,low grade fever, vomiting
65 2021-02-09 fatigue, chills, headache, fever Headache, chills, fatigue, low grade fever
65 2021-02-09 fatigue, chills, fever, headache Headache; chills; fever; Vomiting; exhaustion; This is a spontaneous report from a contactable other... Read more
Headache; chills; fever; Vomiting; exhaustion; This is a spontaneous report from a contactable other healthcare professional. A 65-years-old female patient received bnt162b2 (BNT162B2; lot number=EL8982) second dose, via an unspecified route of administration on 20Jan2021 10:30 AM at SINGLE DOSE left arm for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) 75 mg for hot flasjes. Historical vaccine included first dose of Pfizer COVID 19 vaccine (lot number=EL1284) on 30Dec2020 10:00 AM at left arm for covid-19 immunisation. The patient experienced headache, chills, fever, vomiting and exhaustion, all on 20Jan2021 20:00 with outcome of recovered with sequelae (recovered with lasting effects). Reported as headache, chills, fever, vomiting, and exhaustion the exhaustion lasted more than 3 days and it was severe. Patient had reactions after each short. No treatment received for the adverse event. All events reported as non-serious. Patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19.
65 2021-02-09 throat irritation I had a metallic taste in base of my throat and after that I have like burning in my throat; I had a... Read more
I had a metallic taste in base of my throat and after that I have like burning in my throat; I had a metallic taste in base of my throat and after that I have like burning in my throat; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 65-year-old female patient received bnt162b2 (BNT162B2, Covid Vaccine, lot: EL3247, Expiration Date: 30May2021), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. Consumer stated, "I had the shot (Covid vaccine, Pfizer) a couple of days ago and I experienced the weird side effects. I just wanted to know if that was normal things or if I need to report this? I had a metallic taste in base of my throat and after that I have like burning in my throat. I had another question before you change. I was reading the pamphlets that was given to me at the clinic and it says that it is been in clinic trial an approximately 20,000 individuals have received the vaccine is that all? I had the vaccine on 21Jan2021 and it started immediately afterwards. No, it went away on following day." No treatment received. The outcome of the event was recovered in Jan2021.
65 2021-02-09 headache Light headache; her face was swollen; her throat was swollen little bit; This is a spontaneous repor... Read more
Light headache; her face was swollen; her throat was swollen little bit; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9262 and expiration date May2021), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetes. The patient has concomitant medications (unspecified), taking a lot of medications. The patient had light headache on 23Jan2021, and she noticed her neck, her throat was swollen little bit, and her face was swollen in Jan2021. She doesn't know what she should do. She doesn't have any pain or anything, she feels great. The patient took Tylenol one time and that's it, the headache went away. It was not a bad headache, it was a light headache. Outcome of the event headache was recovered in Jan2021 while unknown for other events.
65 2021-02-09 sleepiness, headache On 01/30/2021 at 08:00 had an extreme headache. Then having extreme difficulty keeping my eyes open... Read more
On 01/30/2021 at 08:00 had an extreme headache. Then having extreme difficulty keeping my eyes open, like I was trying to drift off to sleep. Immediately there after, I started vomiting. These symptoms lasted 4 days extremely fast and hard. Tylenol was take for the headache and helped very little. I slept a lot and I couldn?t eat or drink anything witching vomiting it back up. Even my regular meds with a little water came back up. The evening of the 4th day, I was able to keep clear broth down and crackers helped with the nausea some. The following week, I still didn?t feel quite right and kept fighting off sleep. Today is the 10th of February and toe nausea has returned. Getting out of bed, I dry heaved for an hour. I feel if I eat anything it?s going to come back up. My theory is that the side effects didn?t go away the week I felt somewhat better and had resurfaced, starting out slowly like before. I called my primary at the VA and we discussed what I was already doing i.e. a bland diet until I feel better.
65 2021-02-09 headache, chills, fatigue On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, h... Read more
On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 11Jan2021 14:00 at SINGLE DOSE on Right arm for covid-19 immunisation. Medical history was none. No-covid-prior-vaccination. No Known- allergies. Concomitant medication included atenolol (TENORMIN), clonazepam (KLONOPIN), sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). No-other-vaccine-in-four weeks. Since 19Jan2021, On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit]. No treatment received. Covid-test-post-vaccination: included Nasal Swab, Pixel by Labcorp, covid test date on21Jan2021 was Negative. The event recovered in Jan2021. Information about lot/batch number has been requested.
65 2021-02-09 headache, malaise, fatigue Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm wa... Read more
Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program. A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
65 2021-02-09 fatigue feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed;... Read more
feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed; pain in the injection site; joint pain; muscle pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3247), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient thinks she could have COVID last Mar2020. She was not sure because her doctor's office was close for around a month and she couldn't get tested. There were no concomitant medications. On that day, 19Jan2021, after she received the vaccine she started feeling pain in the injection site, joint pain, muscle pain and fatigue. On 25Jan2021, she was feeling pretty bad, she doesn't want to eat, her back hurts, she's irritable and depressed. The patient would like to know if these side effects could be associated with the vaccine in someone who had the virus. She felt awful and she felt like she has gone right back to where she was 8 months ago, 10 months ago and started over with fatigue and everything. It was awful. She thinks she could have had COVID in Mar2020 and the symptoms she was having now, she had then and when she has had basically the whole time and that would just come back worse. There was no treatment received for the events. The outcome for the events was unknown.
65 2021-02-09 cough, fever, malaise positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. Medical was none. There were no concomitant medications. The patient got covid positive/the covid-19 virus molecular test was positive on an unspecified date with outcome of unknown. On 20Jan2021 the patient started with the first symptoms of got very sick, had terrible body pain, sharp pain and aches, terrible cough, fever and felt completely like physically collapsed. The patient got positive covid-19 virus molecular test on 23Jan2021 with outcome of recovering. On 22Jan2021 the antigen test was negative. On 23Jan2021 the patient had also a negative flu rapid test.
65 2021-02-09 headache, chills vomited; chills; headache; had some itching, ongoing soreness and lump at site; had some itching, on... Read more
vomited; chills; headache; had some itching, ongoing soreness and lump at site; had some itching, ongoing soreness and lump at site; had some itching, ongoing soreness and lump at site; nauseous; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 19:00 at a single dose for COVID-19 immunization. She takes thyroid daily (as reported) as it was removed when she was 20. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination. The patient had not been tested for COVID post vaccination. The patient has not received any vaccine in 4 weeks. Concomitant medication included teriparatide (FORTEO) daily injection, diphenhydramine hydrochloride (BENADRYL). The patient previously took codeine and experienced allergies: codeine. The patient reported that no one knew if she should inject with teriparatide. On 22Jan2021, she received teriparatide at 4pm and bnt162b2 at 7pm. She took a diphenhydramine and had some itching, ongoing soreness and lump at site. She took teriparatide at 3:30pm at about 7pm she was nauseous and vomited. She had chills but felt better afterwards. She went to bed and have headache, not sure if she should discontinue teriparatide or discontinue before next shot. According to the reporter, the events started on 23Jan2021 19:00; vomited started on 23Jan2021 21:00. The outcome of the event was recovering.
65 2021-02-10 headache Severe pain in left arm muscle-icing, Tylenol, Advil Headache Nausea, vomitX1
65 2021-02-16 headache About 10 hours after vaccination a headache started. Then my joints started hurting almost like a ne... Read more
About 10 hours after vaccination a headache started. Then my joints started hurting almost like a nerve was firing off but only at the joints, ie knee, shoulder, toes, ankle, fingers, toes, etc. It would happen randomly. Never all joints at once. Very weird. Continued throughout the night making it difficult to sleep. In the morning, at 7 am, got up out of bed. Took 2 Advil. At 10:20 I still have the joint happening but not as frequent and not as strong. I still have the headache. It hasn't changed.
65 2021-02-17 malaise trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feelin... Read more
trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feeling very shaky and very weak; feeling unwell; alternating slow heartbeat and fast heartbeat; a weird feeling in her head like pressure but not a headache/pressure feeling in my head; they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction.; This is a spontaneous report from a contactable consumer. A 65 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 31Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included allergic to shrimp, lupus anticoagulant syndrome, chronic kidney disease and antiphospholipid syndrome. Concomitant medications included amlodipine, HCTZ, losartan, acetylsalicylic acid (ASPIRIN (E.C.) and atorvastatin calcium (LIPITOR ORIFARM). The patient informed that immediately after receiving the injection she felt a lump in her throat and could not swallow, still present now. Patient also informed that after vaccination she was having a very high blood pressures, feeling very shaky and very weak, a weird feeling in her head like pressure but not a headache, trouble sleeping because of the pressure feeling in my head, feeling unwell and alternating slow heartbeat and fast heartbeat. Patient also reported she had scheduled an allergist appointment and they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction. At the time of the reporting event outcome was unknown.
65 2021-02-18 throat pain Started feeling bad, throat started hurting, lost voice. Still am unable to talk very well and has ... Read more
Started feeling bad, throat started hurting, lost voice. Still am unable to talk very well and has been going on for 4 weeks.
65 2021-02-21 influenza like illness Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even ... Read more
Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even soles of feet. Difficulty sleeping that night. Could not sleep on left side for about 3 days. Knees ached, difficulty walking.
65 2021-02-21 chills, fatigue, head discomfort, headache, sweating Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and... Read more
Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and got up to go to the bathroom but felt fine. Went out to the hall bathroom so as not to wake husband in Master bath. Urinited and got up slowly as I always do and walked out to the hallway to go back to bed. I lost consciousness and came to when my husband who heard a thud came and found me out having fallen down the stairs.. head on the landing and feet above the landing. I have no recollection of it once leaving the bathroom and i would have headed away from the stairs which was just to the left of the bathroom doorway. I didn't feel any pain. Later found a bump on my forehead of the right side of my face and a bruised lip. He said my back was wet with sweat and I took a couple minutes to come to. After returning to the bed.. i immediately had to empty bowels. Diarrhea.. then the rest of the night in Chills. No fever. Slept most of the next day and night. Headache and joint aches and swelled lymph nodes in neck.. Fatigue through 20th. Mostly better by the 21st. Still today on 22 I am being careful when going from prone to standing. I feel more head pressure getting up and maybe I notice a little nausea when rising. I may just be worried about fainting again. It has never happened to me before. I do have very good blood pressure on the lower side so I was always careful to get up slowly but never fainted. Neck is sore.. Not sure if lymph nodes or something to do with fall.
65 2021-02-21 chills, headache, fatigue I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over a... Read more
I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over all my body (joint/muscle pain) that started about 10 PM the night. I woke up Saturday morning with a bad headache, felt like I was pass out, I had chills. Saturday afternoon I noticed under right armpit the lymph nodes were swollen. The pain radiates throughout my chest and shoulder but most severe under the armpit. As of today 22nd I feel tired and I am still experiencing the swollen lymph nodes under my right arm pit. All the other symptoms have went away. The lymph node feels warm to touch, there is also a small area of redness around the injection site. I am still having post COVID-19 symptoms as well which include nasal issues, weakness and brain fog. I have had all these symptoms since November.
65 2021-02-21 cough, headache, runny nose, fatigue all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness... Read more
all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
65 2021-02-21 cough, malaise, headache, runny nose my results came back stating I was positive; feel ill with a severe back pain on my left side. The s... Read more
my results came back stating I was positive; feel ill with a severe back pain on my left side. The same side where I was given the shot; cough; runny nose; headaches; a lot of pain in my bones; a lot of pain in my bones, and eye lids; Feel ill; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 11:00 at the age of 65 years old at a single dose for COVID-19 immunisation at the school/student Health Clinic. Medical history was none. The patient has no allergies to medications, food and other products. The patient is not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 07:00, patient began to feel ill with a severe back pain on her left side. The same side where she was given the shot. In addition, patient also experienced a cough, runny nose, headaches, a lot of pain in my bones, and eye lids. At first, she believed it was due to the vaccine but as she got worse, she decided to take a COVID test (nasal swab) on 31Jan2021 and the results came back stating she was positive. Since then the patient has been in quarantine. No treatment was received in response to the events. The patient was recovering from the events. The patient has a second vaccination appointment scheduled on 13Feb2021 and would like to know if she will still go as scheduled or will she need to go in a later date. Information on the lot/batch number has been requested.
65 2021-02-22 chills, malaise 78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I ... Read more
78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I felt hot and chilled... I am not sure it was related to the injection. It resolved on sat Feb 20th 2021. I still have mild nausea but am on Ozempic which gives me nausea some of the time. I did not feel well but finally fell asleep and slept until AM.
65 2021-02-22 headache, sleepiness Headachy. Feel very soundly asleep for 3 hrs on day of shot. Same thing next day. Woozy head most of... Read more
Headachy. Feel very soundly asleep for 3 hrs on day of shot. Same thing next day. Woozy head most of the day. Considered not drivinv.
65 2021-02-22 headache, fatigue, chills, malaise I was vaccinated nine days ago. I have consistently been having chills, a dull headache and fatigue... Read more
I was vaccinated nine days ago. I have consistently been having chills, a dull headache and fatigue. I was really sick by the end of the day after the vaccine. The fatigue, initially, put me in bed for a few days. It is not as severe now. It is mild to moderate. I feel week sometimes. It comes and goes.
65 2021-02-22 chills, headache, fever In the pt's words " received our second covid-19 vaccination on Sunday. I got my vaccination about 1... Read more
In the pt's words " received our second covid-19 vaccination on Sunday. I got my vaccination about 10:00. By 8:00 PM I was not feeling well. Had all of the side effects, chills, fever, muscle aches, joint pain and a wicked headache. Monday was the same minus the headache. Today, still have joint pain and feel very weak. The nurse that gave us our vaccinations said that if we experienced any of the side effects, we should let our primary physician know. Hopefully all of this is normal and I will be back to my normal self soon. I am concerned because most of the information I have read says 24 hours and effects should be gone. Not so with me. Hope all is well with you and your family. " Spoke w/ pt on phone and she stated her s/s are subsiding, other than the arthralgia, RN
65 2021-02-23 fever, chills 1 day of fever, chills and bad diarrhea
65 2021-02-23 headache, chills, fatigue, fever 5:00 pm 2/23 headache/ fatigue 1:30 am 2/24 chills, headache, racing heart, shortness of breath, low... Read more
5:00 pm 2/23 headache/ fatigue 1:30 am 2/24 chills, headache, racing heart, shortness of breath, low grade fever , aches
65 2021-02-23 headache About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,... Read more
About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,, and sinuses. States burning feeling is easing yard headache spending to top of head. Client instruct to go home and have husband drive. Plans to take her migrain meds. Says her migraines can start this way too. Left AR 12:13
65 2021-02-23 influenza like illness I was sick like when you get the flu for two straight weeks. I had absolutely no energy or will to ... Read more
I was sick like when you get the flu for two straight weeks. I had absolutely no energy or will to do anything. Couldn't get out of bed and it felt like my skin was crawling all the time. I have never been so sick in my life. I am NOT getting second shot because NO doctor will help me understand what happened to me. But, you need to know!
65 2021-02-23 chills, fatigue, cough Shaking from being cold. Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwar... Read more
Shaking from being cold. Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwards. Couldn?t eat for / days afterwards. Bad dry cough still persists now 2 weeks later. Took Tylenol nothing helps the dry cough
65 2021-02-23 fever pfizer jan 29 pfizer feb 19 Pfizer #1 EL 9263 Pfizer #2 EL 9267 low grade fever of 99.0, palpitatio... Read more
pfizer jan 29 pfizer feb 19 Pfizer #1 EL 9263 Pfizer #2 EL 9267 low grade fever of 99.0, palpitations, and diarrhea yesterday. Recommended that she see her primary provider if symptoms worsen.
65 2021-02-23 fever, chills pt developed rash on b hands that appeared to be chillblains, along with usual side effects of myalg... Read more
pt developed rash on b hands that appeared to be chillblains, along with usual side effects of myalgias, fever, chills, arthralgias. rash lasted a little over a week and resolved on its own.
65 2021-02-24 fatigue, headache Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired... Read more
Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired. started about an hour later. Did not sleep well. Stayed in bed the next 2 days. Tightness in chest went away the second day. Third day I felt like myself. These were things that I also experienced with Covid.
65 2021-02-24 chills, headache Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); pos... Read more
Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); possible slight swelling of face and eyes (minor); chills; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 15:15 at a single dose for COVID-19 immunization. Medical history included hypertension and kidney disease, and was allergic to bee stings, penicillin, aluminum chloride. Patient was not pregnant at the of vaccination. There were unspecified medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks prior to. The patient experienced hot red face and neck, possible slight swelling of face and eyes (minor), chills and headache on 29Jan2021 15:30. Outcome of the events was recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
65 2021-02-24 headache No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right ... Read more
No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right bodice, up the back of my neck and head on only the right side. I took Tylenol, placed hot packs on the area and drank fluids. I took Advil at 4:00 a.m. Fell asleep and woke up at 8 a.m. I had no temperature but headache was intense. I ate a small breakfast and stayed quiet with hot packs on all areas - 5 p.m. I was feeling much better - went to bed at 7:00 p.m. next morning I was ok.
65 2021-02-24 chills She did not have any reactions initially, but noticed the morning after the vaccine that her regular... Read more
She did not have any reactions initially, but noticed the morning after the vaccine that her regular cup of coffee did not taste good. She then had a rash that started on the left side of her neck, went towards the back now. This started a few days after the vaccine, all on the left side. She also got a cold sore on her lip which she had all the time as a child, but not as an adult, which has pretty much resolved. She has been cold, chills and some dizzy spells. She did get a bump on her head concussion in December. One day last week she just stayed on the sofa with a blanket due to feeling poorly. 3 days ago on her back by her shoulder blade an area has been really sore. She did take some Tylenol for the back pain which did not help so she stopped this. She did not call her doctor. The rash is still there but not as intense. It has not itched, but she has felt it.
65 2021-02-24 headache The rash is up under arm, in armpit and is in the same arm of injection but there is no rash at the ... Read more
The rash is up under arm, in armpit and is in the same arm of injection but there is no rash at the injection site.; because there was some itching under the arm. I went to see a dermatologist who says it has nothing to do with vaccine. I also had a slight headache; I also had a slight headache a day or two after the shot; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on 14Jan2021 on left arm at a single dose for COVID-19 immunisation. Medical history included chronic kidney disease. The patient had chronic kidney disease and its real important for someone with her disease to get the vaccine, because if she got the actual virus it would hit the kidneys hard. The patient had no positive covid or antibody test prior to the vaccine. Concomitant medications were none. The patient stated that only thing she thinks would be related was that, she noticed this rather after using the hot tub, her husband just cleaned the hot tub and put chemicals in it, maybe she had a reaction to chemicals used to clean the hot tub. On 24Jan2021, the patient was reported after 10 days the patient had rash was up under the arm, near the arm pit, in the same arm of injection but there was no rash at the actual injection site, however her skin was beautiful, there was no spot except under the armpit. She got the injection a week ago Friday, she noticed the rash days later, on Sunday with itching under the arm. The Dermatologist says it has nothing to do with vaccine. The patient also had a slight headache a day or 2 (on 15Jan2021) after the shot, not a migraine, it was a slight dull headache, but went away. The patient went to the dermatologist yesterday, and he said it had nothing to do with the vaccine. She went to the dermatologist on 26Jan2021. Caller again stated that there was no rash at the injection site, but there was a rash underneath the arm in the arm pit. She still has it, she just started to use medicine last night. It's getting better. The Dermatologist prescribed a topical cream and its some kind of cortisone. The patient did not have any severe reaction like head swelling or swelling. The patient was scheduled for her second dose on 05Feb2021. The patient recovered from headache on 16Jan2021, recovering from rash, and for itching it was unknown.
65 2021-02-24 chills, malaise, headache, fever, fatigue Tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell
65 2021-02-24 sweating Within 15-minutes of vaccination, the patient reported feeling flush, near-syncopal, dizzy, and ligh... Read more
Within 15-minutes of vaccination, the patient reported feeling flush, near-syncopal, dizzy, and lightheaded with diaphoresis. EMS evaluated patient on-site. Patient was hypotensive (89/60). 12-lead EKG showed sinus tachycardia, rate 102 bpm, no ST elevation. EMS transported the patient to Emergency Department for further evaluation. In ED, patient was hypertensive (155/65) with all other vitals WNL. Repeat EKG indicated NSR, low voltage QRS, with no ischemic appearing ST changes. ED physician administered 1L saline bolus and 650mg Acetaminophen. Patient reported feeling better and was discharged with a differential diagnosis of vasovagal episode, electrolyte imbalance, and volume depletion.
65 2021-02-25 headache Diagnosed with May-thurner syndrome; Deep vein thrombosis; Both of her feet were only slightly swoll... Read more
Diagnosed with May-thurner syndrome; Deep vein thrombosis; Both of her feet were only slightly swollen; Dull minor headache; Off-label use; Inappropriate schedule of vaccine administered; Localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (weight: 77.56 kg, height: 157 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the upper left arm, on 23Jan2021, for COVID-19 immunisation. Relevant medical history included thyroid condition from an unspecified date (over 25-30 years before this report) and ongoing, controlled with levothyroxine sodium (SYNTHROID); and breast cancer from an unspecified date, in 2019 (treatment and surgery on an unspecified date, in 2019. Presumed resolved with radiation treatment, but no treatment within a year prior to getting Pfizer COVID-19 vaccine). The patient previously, on 05Jan2021 (18 days before the second dose), received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunisation. After the first dose, the patient experienced localized discomfort at the injection site and swelling of feet. Concomitant medication included levothyroxine sodium (SYNTHROID) from an unspecified date and ongoing, 0.88 mg, daily, for thyroid condition. On 23Jan2021, the patient experienced injection site discomfort described as "localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given". On 24Jan2021, she had dull minor headache. On an unspecified date, the patient was hospitalized after the second dose and was diagnosed with May-thurner syndrome. She clarified that May-Thurner syndrome was where the iliac artery collapses and crushed the iliac vein in the upper abdomen; from that point down it started creating a blood clot. She developed a deep vein thrombosis (DVT) from her left ankle up to her right rib cage area; it was a monster. On 10Feb2021, the patient experienced deep vein thrombosis and thrombectomy was performed on the same day (outpatient thrombectomy surgery, performed 10Feb2021. It was a great surgery, very corrective. She never did have any pain or discomfort which confused everyone. She felt fine this whole time, no issues). On an unspecified date, both of her feet were only slightly swollen. Relevant laboratory test, performed on an unspecified date, in 2021, included computerised tomogram (CT scan with contrast of her abdomen and chest) that showed deep vein thrombosis: left ankle-right ribcage area. The adverse events May-Thurner syndrome and deep vein thrombosis were assessed as serious, hospitalization required from 02Feb2021 to 10Feb2021. The patient recovered from deep vein thrombosis on 10Feb2021, recovered from headache on 26Jan2021, recovered from swelling of feet and vaccination site discomfort on an unspecified date, while clinical outcome of the other events was unknown. Her vascular surgeon said he did not believe these events were vaccine related but cannot rule it out; her Primary Care Physician absolutely believed the events were vaccine related. The information on the lot number has been requested.
65 2021-02-25 headache Headache; BP 136/84 (pulse 74), O2 sat 98%. Given crackers and water.
65 2021-02-25 headache, throat pain, fatigue On February 23 (1 week after 2nd vaccine), I experienced sudden onset of swollen lymph node in left ... Read more
On February 23 (1 week after 2nd vaccine), I experienced sudden onset of swollen lymph node in left side of neck and sore throat, headache, difficulty swallowing, fatigue, some sinus symptoms and stuffy ears. Today is February 26 and I am still experiencing the same symptoms, somewhat less intense than initially. I called my primary care doctor's office and was told by the receptionist that this was a reaction to the vaccine and should subside in a few days and if not to call back.
65 2021-02-25 throat irritation Pt has a history of multiple drug allergies including anaphylaxis. Prior to COVID 19 vaccination we ... Read more
Pt has a history of multiple drug allergies including anaphylaxis. Prior to COVID 19 vaccination we discussed her reaction to previous Pneumovax 12 years prior. Several minutes following administration of the Pneumovax, she developed scratchy throat and hoarseness. Benadryl was administered with improvement in symptoms. She did not require epinephrine or ER visit. We discussed that she had a higher risk of reaction to the COVID 19 vaccine and advised her to wait 30 minutes post injection. During her wait time she began to develop scratchy throat and hoarseness that progressed over 10 minutes. She was taken to the treatment area where vital signs were obtained and 50 mg of oral Benadryl was given. Initial VS were SpO2 of 98, P 82, BP 140/100. She was alert and oriented. No edema lips or tongue. Heart RRR Lungs CTAB with no wheezes. She remained under observation for 30 minutes, vital signs remained stable and BP ranges from 138-140/80-90. She had noticable improvement in her throat and voice and she was discharged in good condition to home under the care of her husband. They were advised that Benadryl could be repeated in 4-6 hours if needed. Should she develop any facial swelling, shortness of breath, wheezing or lightheadedness they should proceed to the emergency department. Reviewed the newly updated CDC guidance on reactions. Although her reaction was immediate it was not considered severe. CDC advised against getting the second vaccine. She is advised to discuss further with her allergist, Dr if she would like to discuss the possibility of getting the second dose with premedication or other precaution. She and her husband understood well and all questions answered.
65 2021-02-25 malaise anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, w... Read more
anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, weakness, unable to take anything by mouth/had lost ability to swallow; swallowing, weakness, unable to take anything by mouth; affected my lungs, gut, muscles, everything.; still having lung issues; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number RM9809), via an unspecified route of administration on 03Feb2021 at the 65 years old at single dose for COVID-19 immunization. The medical history included Muscular dystrophy. The concomitant medications included unspecified multiple medications. The patient received the first dose on 03Feb2021. Immediately after the vaccine on 03Feb2021 she had an anaphylactic reaction, received an Epipen, went to the ER was given steroids and sent home. Next day, still having symptoms, received second Epipen administration, went to Urgent Care, was admitted to hospital 04Feb2021. The patient stated she had a history of muscular dystrophy. She stated she was having issues breathing, swallowing, weakness, unable to take anything by mouth, didn't have normal respiratory support in Feb2021. It had affected her lungs, gut, muscles, everything. She may leave here on hospice. She wanted to know if there were others who had reported side effects such as hers. She had anaphylactic reaction to the mineral. She was still in the hospital. She had lost ability to swallow and she was still having lung issues in Feb2021. She was a disabled rehab healthcare worker. She did not have an address right now in the hospital but if sent her something later once she get out she will be able to do that but she did not have it now. She takes multiple medications. Right now she cannot take medications she need orally. She had gone to hospital getting meds via primarily IV. She had acute anaphylactic reaction immediately after the vaccine and went by ambulance to hospital and was given steroids, care basically and sent home and she still had issues the next day and it kept going from home to urgent care to admission at the hospital. She had done lot of lab tests in Feb2021. She was very concerned that this was not going to be a temporary issue. She had form of muscular dystrophy and now what was happening was the week before she got the vaccine totally independent in her home, feeling ok, medications okay and now she was at IV medications not being able to swallow. She talked to someone yesterday and they told she should be calling and reporting what happened and that was why she had been on the phone all day. She just want make sure she did not feel like the healthcare was reaching out to their own vaccination department and she want to make absolutely sure that not only does Pfizer know that have a horrid reaction but she want the healthcare firm that she had a horrid reaction and she want the CDC to know that she had a horrid reaction because right now she would tell all her friends with the severe form of muscle dystrophy she had not going to be vaccinated even though the researchers were telling her to get vaccinated. It was going to take a while to stop the efficacy again and having to be on the phone everyday when she was barely breathing. The patient underwent lab tests and procedures, which included Lab test unknown result in Feb2021. The outcome of the events was unknown.
65 2021-02-25 headache, fatigue one day later, headache and a few instances of vertigo. 3 days later sudden fatigue/weakness/dizzine... Read more
one day later, headache and a few instances of vertigo. 3 days later sudden fatigue/weakness/dizziness in the evening that went into the next day.
65 2021-02-25 chills, cough, fatigue same symptoms as when I had Covid in March 2020. Pain, fatigue, chills, cough, ...
65 2021-02-26 headache Headache off and on for three days so far; treatment--bed rest.
65 2021-02-27 fatigue, chills, body temperature increased 103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second da... Read more
103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second day: 101 fever, chills, terrible fatigue and a red rash over entire body.
65 2021-02-27 headache Headache, very sore muscles in body as if struck byatruck,fever 100.7
65 2021-02-27 headache, influenza like illness, fatigue flu-like symptoms - no fever, muscle and joint aches, headache, flare up of psoriasis, fatigue
65 2021-02-27 malaise, headache, fatigue, chills, fever injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swell... Read more
injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, malaise
65 2021-02-28 throat irritation 20 minutes after the injection of COVID -19 vaccine, patient reports a itchy throat, administered pa... Read more
20 minutes after the injection of COVID -19 vaccine, patient reports a itchy throat, administered patient own dose 0.3mf EpiPen into right thigh and Benadryl 50mg IM right deltoid, patient taken by EMS to hospital
65 2021-02-28 fatigue, headache Bilateral numbness, headache, tongue feels weird, really tired, hx liver transplant
65 2021-02-28 fatigue, cough, headache Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe c... Read more
Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.
65 2021-02-28 influenza like illness I went for my second shot of Pfyzer vaccine and everything was fine (including the waiting period be... Read more
I went for my second shot of Pfyzer vaccine and everything was fine (including the waiting period before leaving the event). During the night felt mild flu symptoms, but not bad. The next day, Sunday February 28, around 8:00 pm I noticed (while putting my car seatbelt ) I felt a lump on my left side of my neck below my ear. Before going to bed last nine I had some mild flu symptoms but no pain. As of today, I still have the lump or nodule.
65 2021-02-28 malaise She didn't feel well last night; Weakness in left thigh and leg/leg was so weak she could not get up... Read more
She didn't feel well last night; Weakness in left thigh and leg/leg was so weak she could not get up; Fell down 3 times; This is a spontaneous report from a contactable consumer (patient) and healthcare professional. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 25Jan2021 11:30 at single dose (arm left) for COVID-19 immunization. Medical history included costochondritis, vertigo, autoimmune disease, uses a walker, inflammation of the cartilage between the rib and sternum and pulled muscle. Concomitant medications included methylprednisolone (MEDROL) (also reported as steroid pak) from Jan2021 to Jan2021 for pulled muscle and ketorolac tromethamine (TORADOL) from Jan2021, both for inflammation of the cartilage between the rib and sternum. The patient previously took iodine and experienced allergies. It was reported that the patient just got the first Pfizer BioNTech Covid-19 vaccine yesterday, 25Jan2021, 11:30 am. Last night, at 19:00, she had weakness on the left side of the body, especially in the thigh, and she fell down 3 times last night. Her leg was so weak she could not get up. She just got off the phone with the doctors office and was told to report this. The patient did not received therapy for the events weakness in left thigh and leg/leg was so weak she could not get up and Fell down 3 times. On 26Jan2021, the patient experienced didn't feel well last night. She was also on a Medrol pack about a week ago and just finished her last dose last night when she took the vaccine. The nurse practitioner at the doctor's office was wondering if it could have been an interaction between the Medrol pack and the vaccine. She got an email saying she could get the vaccine, but didn't think to call the doctor office to ask about the Medrol pack (steroid pack) or if it could cause any interactions. So the office told her to call. Later mentions along with the Medrol pack, she got an injection in the office of Toradol and this was before getting the vaccine. She stated that she did have her on a steroid pack for a pulled muscle so that may have exacerbated the issue. The weakness and things have improved so she was still a little nervous and uses a walker and just making sure to take it easy today. The patient had no other vaccines in 4 weeks and other medications in two weeks included steroid Pak. Patient had no problems with vaccines in the past. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The patient had no events following prior vaccinations. Patient stated that they had been lucky and they have been tested before and has not had it yet, so that was why they wanted to get the vaccine done. She just rested and her husband helped her to bed since she didn't feel well last night. She did not have any trouble breathing. Patient underwent a Chest x-ray in Jan2021 and nothing showed up on it, but just some old calcifications from many years ago. That was done sometime last week and she also had like 3 MRI's on an unspecified date. Patient was wondering if she should she get the second dose. Her next appointment was on 16Feb2021. She was pretty banged up and does not want to have to go through that again. Outcome of events was recovering.
65 2021-02-28 headache Technician thought the dose looked funny in the syringe but, didn't notify the pharmacist until she ... Read more
Technician thought the dose looked funny in the syringe but, didn't notify the pharmacist until she gave the vaccine and the next one pulled funny too. Then she notified me about the vaccine looking funny and upon inspection, there was no vaccine in the syringe. We pulled the rest of the shots in the vial and found that there was an extra shot. We concluded that this patient must not have actually received any vaccine in her dose and called her back to give her another dose. Patient was fine at the time of the incident and I followed up with her n 48 hours and she is still fine and no side effects to her arm. She did say that she had a headache but, that could have been due to the weather and not necessarily the vaccine and otherwise she feels fine with no other side effects or health issues.
65 2021-02-28 fever, headache, fatigue, chills Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night w... Read more
Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night with fever, chills, bad headache and body aches head to toe. Took Tylenol. Woke in the morning with fever (101.8), chills, bad headache, body aches head to toe, joint aches and nausea. Took Tylenol. Too sick to get up all of Saturday. Saturday afternoon vomited. Saturday evening fever broke and began feeling a little better. Sunday still had a bad headache, body aches and joint aches. Today, Monday, feeling better but still have a mild headache, body aches and joint aches. I also feel really week and tired.
65 2021-02-28 fever, chills, headache shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a ... Read more
shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a non-contactable consumer. A 65-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not available/provided to reporter at the time of report completion), via an unknown route of administration on 25Jan2021 at 10:00 AM at a single dose at the age of 65 years old for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included at the age of 64 years, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 25Jan2021 at 22:00, after receiving 2nd dose of COVID-19 vaccine in morning, patient experienced chills, shaking, fever, joint pain, loss of appetite, and headache later that evening. She stayed home from work for 2 days and felt better 48 hours later. The reporter assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, if patient was tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
65 2021-03-01 respiratory tract congestion, cough, pneumonia 2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the or... Read more
2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the original. NURSING HOME ACUTE VISIT 6/24/1955 MD SUBJECTIVE: Chief Complaint Patient presents with ? Cough Pt has COVID 19 and she is coughing and congestion. This is an acute visit with pt. Status and changes discussed with staff. Advanced directives on file. Allergies reviewed at NH, though may not be fully updated in electronic record. Problem List reviewed. ROS: Gen: Denies fever CV: Denies chest pain Resp: Denies dyspnea GI: Denies abdominal pain. GU: Denies dysuria. Psych: Denies depression. OBJECTIVE: VITALS: Vitals: 02/03/21 1226 BP: (!) 94/54 Pulse: 79 Resp: 18 Temp: 37 °C (98.6 °F) SpO2: 96% PHYSICAL EXAM: General: Alert, awake, no acute distress Skin: Intact HEENT: Grossly normal Neck: Supple Lungs: Within normal limits/clear CV: RRR Abdomen: Soft, BS active Extr: WNL Neuro: Unchanged and nonfocal ASSESSMENT/PLAN: Reviewed and signed orders. Recheck in 60 days. Patient was seen today for cough. Diagnoses and all orders for this visit: COVID-19 Cough CXR 2 view. Plan to start melatonin, vit D3, zinc. Rehab nurse note: Table of Contents for Miscellaneous Notes Telephone Encounter - RN - 02/09/2021 9:30 AM CST Telephone Encounter - 02/09/2021 9:16 AM CST Telephone Encounter - RN - 02/09/2021 9:30 AM CST Discussed with Dr. and he recommended that patient go to ER for urgent evaluation/treatment with dyspnea and low O2 levels even with supplemental oxygen. Electronically signed by RN at 02/09/2021 9:32 AM CST Back to top of Miscellaneous Notes Telephone Encounter - 02/09/2021 9:16 AM CST Rehab called, they stated PT was having trouble breathing and her O2 was 80 with oxygen. They wanted to know if they should bring her in but PT is Covid positive. Staff recommended that she go to the ER. Electronically signed at 02/09/2021 9:17 AM CST 2/9 ER-> admission note: (6day admission) History The patient is a 65 y.o. female with a past medical history notable for History of anemia, anxiety, cirrhosis, COPD, CHF, diabetes, reflux, hypertension. The patient presents for evaluation of Worsening issues of cellulitis in addition to the patient's history of recent Covid 19 infection. Patient also tested positive for influenza. Patient was started on steroids at skilled care facility. Patient was already on breathing medications. Patient has had issues with CHF and lower extremity swelling. Patient was taking a diuretic for this. Due to patient's cerebral kidney function patient is not a candidate for certain medications or either influenza, Covid 19 and we are limited on antibiotics. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/1/21 er to admission note: currently inpatient History The patient is a 65 y.o. female presents for evaluation of altered mental status. Notable PMHx: CHF, morbid obesity, diabetes, Patient is 3 weeks out from hospitalization for COVID-19 pneumonia. She has been more confused over the couple of days before admission. Because of altered mental status, patient was transferred to the emergency room. Patient also had some shortness of breath. In the ER, she had a chest x-ray which showed moderate interstitial infiltrate secondary to pulmonary edema or pneumonia. Lab work did show a UTI. BNP was normal at 45. Creatinine was near her baseline at 1.8. She did have elevated alkaline phosphatase at 452. White count was elevated at 14.7. Patient was difficult to arouse in the ER. On my exam, patient is difficult to arouse. After shaking her shoulder and yelling at her, she did open her eyes and say to me "I'm ok" before closing her eyes again. She is satting well on nasal canula oxygen.
65 2021-03-01 fatigue Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in... Read more
Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in toes and progressed to whole foot), lower leg weakness and fatigue began 16 days post vaccination. Hospitalization 4 days post symptom onset.
65 2021-03-02 fever, fatigue, cough, headache Low grade fever; headache; cough; fatigue; diarrhea; This is a spontaneous report from a contactable... Read more
Low grade fever; headache; cough; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). This 65-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) via an unspecified route of administration on 28Jan2021 at 14:30 (at the age of 65-years-old) as a single dose in the right arm for COVID-19 immunization. The patient had no medical history (as reported). The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications included levothyroxine from an unspecified date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not have any allergies to medications, food, or other products. On 01Feb2021, the patient experienced low-grade fever, headache, cough, fatigue, and diarrhea. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcomes of low-grade fever, headache, cough, fatigue, and diarrhea were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
65 2021-03-02 lethargy, chills, fever Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle sorene... Read more
Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of bnt162b2 (BNT162B2 also reported as product COVID 19 brandPfizer, lot EL9265), via an unspecified route of administration in left arm on 30Jan2021 13:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included MAC (mycobacterium avium complex) and allergic to strawberries. She had her first dose of bnt162b2 (lot EL3246) on 09Jan2021 in the left arm. The patient's concomitant medications were not reported. The patient previously took rifampin and and experienced, both had drug allergy. On 31Jan2021 12:00, the patient experienced low-grade fever, chills, lethargy, muscle soreness with no treatment. The outcome of events was unknown.
65 2021-03-02 malaise, fatigue, chills, headache Nausea; Dizziness; she feels like the whole house is turning around; slight headache; Chills; overal... Read more
Nausea; Dizziness; she feels like the whole house is turning around; slight headache; Chills; overall tiredness; overall not feeling good; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on the left arm on 29Jan2021 09:49 at single dose for COVID-19 prophylaxis. Medical history included ongoing hypertension (Stated that it is under control with her medication), prevent heart attack, high cholesterol, hepatitis B in 1996, Rubella/measles in 1996. Concomitant medication included ongoing acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) to prevent heart attack, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), simvastatin for high cholesterol. The patient previously took Flu shot for flu vaccination. She stated that she has had adverse events to previous vaccines. She stated that she had a rash and feeling bad. Profuse bleeding with her menses and stated that it lasted a week. Whenever she takes the Flu shot it disrupts her system for a while. Patient also previously took Hepatitis B in 1996 and a booster in 1997, Rubella/measles in 1996 and a booster in 1997, Tdap in 1996, OPV in 1996, Polio in 1996, TD 0.5mg in 2006. The patient experienced chills and overall tiredness on 29Jan2021; slight headache on 30Jan2021; nausea, dizziness and she feels like the whole house is turning around on 31Jan2021. Patient reported that she received the vaccine on Friday 29Jan2021 and said that she has had most of the events that were reported. Patient reported that she had chills, overall tiredness, nausea, slight headache, and overall not feeling good, like unwell feeling. She said that she had dizziness too. She said that she was wondering if she should call the doctor also. She was hoping her symptoms would go away. She said that she feels awful. She said that she feels like the whole house was turning around. She said that she cannot even drive. She said that she had a little bit of soup for lunch and she was nauseous. She said that she took Benadryl after she got home from getting the injection because she was not feeling good. She stated that she went to bed and slept and felt good when she woke up and said that feeling good was short lived. Chills: She said that she had to sleep with 2 layers of clothes. Noticed the chills at 9-10 pm that evening. She stated that she is still feeling chilly, but reported that the temperature is chilly outside. Tiredness: Started that evening after she received the vaccine. She said that she can still work, but she can hardly concentrate. She has to use a lot of focus to get the tasks done. Nausea: She noticed the nausea on Sunday. Slight Headache: She noticed the headache on Saturday 30Jan2021 and said that last night she had to take a Advil for her headache. Overall not feeling good: She thought it would have improved, but it is still there as of today. She said that she just wants to rest and she feels tired. Dizziness: Dizziness started yesterday 31Jan2021 and stated that it was awful yesterday. Patient said that it has slightly improved. The patient was recovering from chills and dizziness; not recovered from slight headache and nausea; unknown outcome for she feels like the whole house is turning around.
65 2021-03-02 sweating, chills, sneezing, fatigue Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, sta... Read more
Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, started going downhill with chills and some sneezing. Managed to get to sleep, but woke up at 1:15 am and could not get back to sleep. Feeling chilled all night. At 5:30 am, got out of bed to take Tylenol and experienced dizziness (briefly blacked-out), sweats, nausea (vomited) and slight diarrhea. After that episode, started to feel a little better, though still a bit woozy and exhausted from lack of sleep.
65 2021-03-02 chills Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got ... Read more
Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got her 2nd COVID-19 vaccination by Pfizer. She had no ill affects until approximately 10:30 p.m. yesterday (2/23/21) at which time she developed chills her symptoms worsened and by midnight she could not move her arms or her legs and her arms and legs felt numb. She did not have any difficulty breathing. She did not have any numbness in her chest and she did not have any shortness of breath. She did not have any rash and she did not have any swelling or have any headache. She relates that she is better now (2/24/21) although she does still feel like she has weakness of her arms and legs she is now able to walk. The only remaining parenthesia is a little bit of tingling in her right arm. She is still experiencing significant fatigue".
65 2021-03-02 sleepiness, headache, fatigue She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Hea... Read more
She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Headache; Tiredness; Sleepy like/She had the sleepiness last night; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), on the left arm, intramuscularly, on 30Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. No vaccine administered on the same day as BNT162B2 and no other vaccines administered within 4 weeks prior to administration. On 30Jan2021, it was reported that after the patient got the shot she felt the tiredness, sleepy-like. She had the sleepiness last night, she slept really good. The patient added that she had the first dose and she was fine. Then at night on 31Jan2021 around 1am or 130am her left arm started hurting really bad, it was throbbing. She could not put her hand over her arm, it was so painful. She called her work and was told to put ice on it and take ibuprofen. Patient also experienced headache on 31Jan2021 and took Tylenol which took away the headache, however, the patient reports headache at the time of reporting. Patient reports that on an unspecified date, she is having a hot flash, states she gets warm and then it goes away. The patient did not visit an emergency room but will see her doctor to report what is going on with her. Patient reports she is not going to take the second dose. She took off work Sunday since it was so bad and could not work like that. She is asking what happens if she does not take the second dose and how long does it take for the first dose to wear off. The outcome of the events tiredness and sleepy-like was unknown, for the event headache was not recovered, for the event left arm started hurting really bad, it was throbbing was recovering, while for the events having a hot flash, states she gets warm was recovered. The patient was vaccinated at an assisted living facility for 65+ and not in a military facility. Information regarding batch/lot number has been requested.
65 2021-03-02 headache chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas... Read more
chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas of dermal filler, which was administered 10/2019 and progressed throughout face; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200, expiry date unknown) via an unspecified route of administration on 13Feb2021 13:15 in left arm at single dose for COVID-19 immunization. Medical history included migraine, joint pain and dermal filler in Oct2019; allergies to penicillin, mango, tree nuts, bees, shrimp. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication received within 2 weeks of vaccination included estrogens conjugated (PREMARIN), celecoxib (CELEBREX), levothyroxine, colecalciferol (D3), cyanocobalamin (B12), ascorbic acid (C) and Mul. The patient previously received first dose of BNT162B2 (lot number EL9262), on 23Jan2021 09:30 AM at Left arm. At 4:30 am 14Feb2021, the patient woke with chest pain, dizziness, joint and muscle pain; and bad headache. Extreme facial swelling began in areas of dermal filler, which was administered Oct2019 and progressed throughout face. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl and Tylenol (today 1 Celebrex). The outcome of the events was recovering. The events were reported as non-serious, did not result in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating, congenital anomaly or birth defect
65 2021-03-03 fever, fatigue Fever migraine extreme fatigue Migraine headache since this vaccine
65 2021-03-03 sweating First Reaction: Three minutes after receiving injection felt lightheaded and dizzy. Symptoms resolve... Read more
First Reaction: Three minutes after receiving injection felt lightheaded and dizzy. Symptoms resolved with food, water, and time Second Reaction: About 36 hours later while doing dishes, felt prickly on both sides of my neck. Both sides of my neck turned pink as though I had a sunburn. Broke out in profuse sweating. Called my doctor who was on call that night. He told me to get Benadryl right away and to keep taking it until symptoms subsided. If they did not subside or got worse I was to go to urgent care, or ER. Treatment: Benadryl every 4-6 hours for 2 days. As each dose wore off I waited to see if the symptoms came back and then took more Benadryl. Issue lasted until Saturday night - 2 days.
65 2021-03-03 malaise, fatigue Nauseous, pain at injection site, fatigued, feeling unwell.
65 2021-03-03 throat irritation Tachycardia, throat "feels funny" - Evaluated by EMS-Cleared
65 2021-03-04 sleepiness, headache 0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-1... Read more
0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-18.She states no issues with 1st dose on 2/12.0923 Pt report pain and HA has resolved now she feels sleepy. VS as follows 148/86, HR-68, 02 sat 98%, r-20. Pt grandaughter accompanied her here.0937 Pt allowed to go home with grandaughter she reports she feels much better. VS as follows 150/89, HR-77, 02 sat 96%, r-18. Pt instructed to f/u with MD as needed.
65 2021-03-04 malaise, chills Dizziness Chills General malaise Temperature (when feeling better temp was 99.3, dont know how high ... Read more
Dizziness Chills General malaise Temperature (when feeling better temp was 99.3, dont know how high it was, didnt feel like I had a temperature)
65 2021-03-04 fatigue, malaise Feeling generally well, malaise, tired Injection site sore
65 2021-03-04 headache Following day around 8pm started having neck pain then numbness in left arm and face with slight hea... Read more
Following day around 8pm started having neck pain then numbness in left arm and face with slight headache. Lasted two days. Let up a little on third and 4th day. Day 5 almost gone still lingering numbness in left side of face.
65 2021-03-04 headache Numbless head face arm and headache. Call to Dr
65 2021-03-04 respiratory tract congestion Six days after receiving my second vaccine at a mass drive-thru site (on 2/25), I experienced plugge... Read more
Six days after receiving my second vaccine at a mass drive-thru site (on 2/25), I experienced plugged ears -- a feeling of congestion, pressure and mild pain. Then three days after that, on 2/28, I became dizzy and nauseous, causing vomiting and a feeling that I may faint. My husband took me to Urgent Care where I was diagnoses with BPPV and prescribed meclizine and ondansetron. I have been doing the Epley maneuver and my condition has improved somewhat, but I still feel fatigued and the pressure in my ears has not subsided. I cannot hear correctly out of my left ear. I am concerned that I now have Meniere's disease, which can be caused by "abnormal immune response" -- the vaccine? I have an appointment with an ENT specialist on 3/25 and hopefully can get some answers at that time.
65 2021-03-04 fatigue, chills about 24 hours later, I started feeling chill, tire and rash on my stomach, feel itchy on my back bu... Read more
about 24 hours later, I started feeling chill, tire and rash on my stomach, feel itchy on my back but very small area. Rash got spread out little by little as day go by, and the chill and tirdness are the same. Rash spread my whole from but not the breast area and the part of the back , my inner upper arm and inner thigh but not a big area. I went to see doctor on the 5 of March and doctor give me Hydroxyzine to take.
65 2021-03-04 chills, fatigue, fever, headache nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gav... Read more
nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gave her a headache; Feeling cold; chills; muscle pain; joint pain; fever; headache/Headaches was reported as worsened; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (also the age at vaccination) receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at the left arm on 26Jan2021 11:00 AM SINGLE DOSE for covid-19 immunization (reported also as To protect herself). Medical history included that she had a heart cath under anesthesia about two weeks prior to getting the vaccine. She clarifies it was on 30Dec2020. There were no concomitant medications. There was no additional vaccines administered on same date. There was no prior vaccinations (within 4 weeks). No family medical history relevant to AE(s) reported. The patient was vaccinated at a Clinic. The patient previously had a flu shot in Oct2020 and the shingles vaccine in Aug2020 (for immunization). It was reported that the patient had headache, fever, chills, muscle pain, joint pain, nausea and diarrhea after the first dose of the pfizer covid 19 vaccine. The patient wanted to know how long these side effects will last. It was also asked if she should get the second dose of the covid 19 vaccine because she had side effects to the first dose and if the side effects to the second dose or worse than the first dose. It was further reported that the patient got her first shot last Tuesday (26Jan2021). Starting Friday (29Jan2021) she got symptoms. Should she be concerned? She has had tiredness, headaches, (on 27Jan2021) and this morning (01Feb2021) she could not lift her head because her eyes were hurting. When she opening them it gave her a headache. She also had muscle and joint pain (on 29Jan2021) and chills (on 30Jan2021) and fever (on 28Jan2021). She got so cold she covered up with blankets and fell asleep (on 01Feb2021). Then when she woke up it was gone. How long should these side effects last? Should she be concerned? Should she contact her doctor? The reporter also says that most of her symptoms started Friday 29Jan2021. Then she clarifies that actually her symptoms started small before then, on Wednesday 27Jan2021. As the week went on more symptoms came and became other things. It was added that she felt like Friday 19Jan2021 is when she felt the infusion all of a sudden hit her body. That is when she felt the virus hit her with symptoms. Right now her head still hurts. She is not taking as many Tylenol or staying on it regularly like she was. Maybe she should do that again. Could not lift her head because her eyes were hurting. When she opened them it gave her a headache: She says she still has dull pain behind her eyes. She no longer has chills but is feeling cold (on 01Feb2021). Like she chest was frozen on the same side that she got the shot in. They told her to take Tylenol to get relief. But she got concerned as the days went on. She is supposed to get the second dose on 16Feb2021. It was added that it was unknown specific times that these occurred. Friday she would say that she felt it all hit her bad around 11 AM after lunch. The outcome of the event headache, Muscle and joint pain was not recovered; for the event Could not lift her head because her eyes were hurting. When she opened them it gave her a headache and Feeling cold were recovering; for the event nausea, fatigue and diarrhea was unknown; and recovered for the events Chills on 31Jan2021, Fever on 29Jan2021. The AE(s) did not require a visit to Physician office nor ER. Case was considered as non-serious.
65 2021-03-04 fever, headache very bad nausea; Throwing up mucus 5 times last sat.; 99.1 temp; dizzy/ think the dizziness was for... Read more
very bad nausea; Throwing up mucus 5 times last sat.; 99.1 temp; dizzy/ think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine; head ache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration (at the age of 65-years-old) on 28Jan2021 10:30 at a single dose in right arm for COVID-19 immunization. Medical history included anemia with blood transfusions, fat, diabetic, constipation, sinus, and manic depression, allergies, immune compromise. Concomitant medication included cyclosporine, lithium, metformin, omeprazole (OMPRAZOLE), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]). The patient reported, "I am immune compromise. I have had some of these health complaints ongoing. The vaccine made the problems worst. Can you tell me what the 2nd dose will do to me? I think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine." The patient experienced very bad nausea, throwing up mucus 5 times last Sat., 99.1 temp, dizzy/ think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine, head ache; all on 30Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 99.1 on 30Jan2021, SARS-CoV-2 test: negative on 01Feb2021. Unknown if treatment received for the adverse events. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted Emergency room/department or urgent care. The case was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
65 2021-03-07 headache High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these hap... Read more
High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these happened around 9:00 p.m. As soon as those signs appeared we rushed her to the ER. The results showed Brain bleed. She was transfered to Hospital where she was valorated again and other series of test were performed. On Tuesday, 02/16/2021 she was discharged from the hospital with Discharge Diagnoses: //Bilateral subarachnoid hemorrhage //Intractable headache //Essential hypertension, uncontrolled//Generalized anxiety disorder. Thursday 03/04/2021 we follow up with the neurologist. Saturday 03/06/2021 she went to the ER with blood preasure of 189/83.
65 2021-03-08 headache, fatigue, chills With the 1st one I had severe chills whre my teeth were chattering the second day, body aches and so... Read more
With the 1st one I had severe chills whre my teeth were chattering the second day, body aches and some fatigue. Lasted about 3 days. With this 2nd one, I woke up the first night with a terrible headache and chills. By morning the chills were gone but I am so tired and my whole body hurts. I had Covid in November and the symptoms are similar to what I experienced with Covid except I had a 103-104 fever and no chills. I had to go in the hospital to get an IV with steriods to help my lungs so I could breathe.
65 2021-03-10 fatigue Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fat... Read more
Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fatigue extreme/felt tired; Myalgia; Pain; This is a spontaneous report from a contactable Nurse. A 65-year-old female patient received first dose of BNT162B2 (BNT162B2; Lot number EL0140 for both doses, expiry date not reported) via an unspecified route of administration to right deltoid on 23Dec2020 at 15:00 single dose, and second dose via an unspecified route of administration to right deltoid on 13Jan2021 15:15 at single dose for covid-19 immunization, hepatitis a vaccine (HEPATITIS A) intramuscular on 29Dec2020 at single dose for immunization and varicella zoster vaccine rge (cho) (SHINGRIX) intramuscular from 29Dec2020 at single dose for immunization. Medical history included osteoporosis from 2011, osteoarthritis from an unknown date, Knee replacement (Reported due to the osteoarthritis, she had her one knee replaced in 2004 and her other knee replaced in 2011), Spinal compression fracture in 2011 (Reported she fell at work and had a spinal compression fracture in 2011. She said the spinal compression fracture was repaired by a vertebroplasty in 2011) and Hypothyroidism (she has had hypothyroidism for a long time, since either 1998 or 2000). The patient's concomitant medications were not reported. The patient experienced rhabdomyolysis on 06Feb2021, fatigue extreme/felt tired on 30Dec2020, myalgia on 30Dec2020, pain on 30Dec2020, petechia on 06Feb2021, muscle cramps/muscle spasms on 17Feb2021, dry skin on Feb2021, itching on Feb2021 and her cpk was over 2400 on an unspecified date. The patient was hospitalized for rhabdomyolysis from 06Feb2021 to 09Feb2021 and reported to have caused disability. All the other events were reported as medically significant. She said she wanted to report to Pfizer that she was admitted to the hospital on 06Feb2020. She said she was in rhabdomyolysis, and the rhabdomyolysis was really bad. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she was given a lot of fluids while she was in the hospital. She said her CPK was over 2400 when she was admitted to the hospital on 06Feb2021. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she has a petechia rash, cramps, muscle spasms, dry skin and itching now. Reported she literally saved herself from dialysis by going to the hospital. She said she kept putting off her symptoms, and took Tylenol and Naproxen for the whole month of Jan2021. She said her symptoms started brewing up from day 1, clarifying that her symptoms were not really bad until 30Dec2020 and 31Dec2020. She clarified on 30Dec2020 she took Naproxen, Ibuprofen, and Tylenol for her symptoms, and nothing helped her. She said she knew her symptoms were not normal for her, and she went for the whole month of Jan2021 with her symptoms. She said finally there came a time when she said "oh no, this is not normal at all", and she told herself she needed to check in at the hospital. She said she took Naproxen and Tylenol, and felt a little better, and drove herself to the hospital. Reported she kept walking and taking medicines, and while at work she diverted her mind from her symptoms, but when she came home she felt tired, and would tell herself she couldn't do it anymore. She said she doesn't know if what she experienced was from the COVID-19 Vaccine, but that definitely she had a reaction to either the Hepatitis A booster, the Shingrix Vaccine, or the Pfizer COVID-19 Vaccine. Reported she received 11 bags of Normal Saline (1000ml per bag) while she was in the hospital. She said fluid resuscitation was the only way to bring her CPK levels down and to treat the rhabdomyolysis. Reported her symptoms have improved. She said her last CPK was 134 on Wednesday, 17Feb2021. Reported she had cramps and severe muscle spams in her right leg on 17Feb2021, and then had cramps and muscle spasms in her left leg the following day. She said the cramps and muscle spams have not gone away completely. Reported she has a small petechia rash on her lower legs. She said at the moment the petechia rash shows up on her leg, she knows she is going to have a muscle spasm in that area. She said last night she had 2 petechia rashes show up on the lateral side of her right ankle. She said the petechia rash started to burn, and her right leg calf muscle became heavy. She said she could tell her right leg calf muscle was going to start to spasm, so she took some coconut oil and applied the coconut oil to her right leg calf muscle and massaged her right calf muscle. She said she had 2 areas of petechia last night (23Feb2021). She said the first time the petechia was noticed was when she went to the Emergency Room on 06Feb2021. She said the petechia has been persisting since that time. She said prior to being admitted to the hospital she never had dry skin or itching, but now she has dry skin and itching. She said she was using coconut oil to keep her skin moist. She stated she had 2 telehealth calls (11Feb2021 & 18Feb2021) because of a petechia rash and muscle cramps and was asking her doctor is she may need to go back to the hospital. The patient underwent lab tests and procedures which included blood work, CBC and Thyroid level on 06Jan2021 with unknown results (she had regular blood work done for her yearly checkup on 06Jan2021 (BMP, CBC, and Thyroid level). Also included CPK on 06Feb2021 greater than 2400, CPK on 09Feb2021 566 and CPK on 17Feb2021 134 (units were unspecified), She said her last CPK was 134 on Wednesday, 17Feb2021. Therapeutic measures were taken as a result of rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain, muscle cramps/muscle spasms, her CPK was over 2400. Outcome of the event rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain and her cpk was over 2400 was recovering. Outcome of petechia, muscle cramps/muscle spasms, dry skin and itching was not recovered.; Sender's Comments: Based on the information currently available, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The Hepatitis A booster and the Shingrix Vaccine may have also played a contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-03-12 headache right frontal/temporal throbbing headache on 2/3/2021 (day of vaccine) followed by right eye optic n... Read more
right frontal/temporal throbbing headache on 2/3/2021 (day of vaccine) followed by right eye optic neuritis on 2/8/2021. No history of demyelinating disease.
65 2021-03-14 malaise, fever Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to ... Read more
Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to Hospital. Was administered IV Benadryl and Prednisone. Slept for three hours. BP dropped to 165 and was released with Benadryl and Prednisone to take for the next four days. Next several days of nausea, diarrhea, fever, weakness, shakes. No energy. Not feeling well until March 14th.
65 2021-03-15 nasal congestion, cough, fatigue, throat pain, headache COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent los... Read more
COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent loss of smell; loss of taster intermittent loss of smell; coughing; congestion; sore throat; headache; Exposure to SARS-CoV-2; Nausea; injection site pain; lightheadedness; Stomach pain; extreme exhaustion; This is a spontaneous report received by Pfizer from Agency, (Mfr. Control No: 2020US004529) through a contactable physician. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Dec2020 (at the age of 65-year-old) as a single dose for Covid-19 immunisation and also started to receive abaloparatide (TYMLOS, Formulation: injection, Lot number: RT01102, Expiration date: Dec2022) via subcutaneous from 20Dec2020 to an unknown date, at 80 ug, once a day for osteoporosis. The patient medical history, included autoimmune disease-Behcet's disease causing ulcers, osteoporosis and constipation, and all were ongoing. The patient concomitant medication was not reported. On 29Dec2020, the patient experienced injection site pain, fatigue, nausea, Stomach pain and Light headness and the patient believed these symptoms were due to the vaccine. On 04Jan2021, the patient was Exposure to SARS-CoV-2. It was also reported that on 16Jan2021, the patient experienced coughing, fatigue, lost taste/smell, congestion, sore throat, headache, respiratory symptoms, general achiness and also had COVID-19 on an unknown date. It was reported that general achiness and respiratory symptoms possibly related to Covid-19 which resulted in emergency room visit on 16Jan2021. The cough was treated with benzonatate pearls. The following relevant laboratory tests were performed: Rapid COVID-19 (12Jan2021), negative, COVID 19 PCR test (15Jan2021), negative, and chest x-ray (16Jan2021), clear, negative. The action taken in response to the events for abaloparatide was unknown. The outcome of the events COVID-19, light headedness, stomach pain, exposure to sars-cov-2 was unknown, for the events nausea, general achiness, respiratory symptoms, loss of taster intermittent loss of smell, coughing, congestion, sore throat, fatigue, headache was not recovered and for the events injection site pain, extreme exhaustion was recovered on 31Dec2020. Information on batch/lot number was requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and contracted COVID on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.
65 2021-03-15 headache Patient felt like going to pass out and she did then, she was probably out less than in a minute; Se... Read more
Patient felt like going to pass out and she did then, she was probably out less than in a minute; Severe headache; Nauseous; Throwing up/Vomiting; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient (weight: 81.65 kg, height 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder form an unspecified date. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder. On 22Feb2021, the patient experienced sore arm. On 25Feb2021, the patient developed severe headache, nauseous, and vomiting (throwing up) and the patient felt like going to pass out and she did then, she was probably out less than in a minute. The patient described as following: so, on 25Feb2021, the headache increased throughout the day and her nauseousness continued throughout the day and in the afternoon with the pain of the headache she thought she passed out, she vomited that gave her little bit of relief but then she took "two (not clarified) Advil and went to bed". Clinical outcome of the adverse events was unknown at time of this report. Patient asked if should be expected the same kind of reaction when she got her second shot.
65 2021-03-17 fatigue, fever, headache, chills Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain r... Read more
Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain redness & swelling; injection site pain redness & swelling; exhaustion; This is a spontaneous report from a contactable 65 reporting for herself. A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6201/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 11:00 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Hashimoto's hypothyroidism. The patient has allergies to halibut and sea kelp. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 22Jan2021 at 03:30 PM (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), rosuvistatin, acetylsalicylic acid (ASPIRIN), probiotic, and vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 23:00, the patient experienced fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion. The events did not require hospitalization. The outcome of the events fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion was recovering. Since the vaccination, the patient had not been tested for COVID-19.
65 2021-03-18 headache Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing... Read more
Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing issues; Dry heaves; Mucus to come out; Nauseous; Dizzy; Headache; Ears became hypersensitive; Senses heightened; Throwed up; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Feb2021 (lot# EN6205), as 0.3 ml single, for COVID-19 immunisation. Medical history included seizure from 2017 (she hasn't had a seizure in 8 months), allergy (to a lot of things). Concomitant medications were not reported. The patient did not have other vaccinations in 4 weeks prior. Within 15 minutes from having the vaccination at the center the patient experienced the first seizure that lasted about an hour. The seizure was really bad, she had breathing issues, dry heaving like she was trying to throw up, mucus to come out. The paramedics checked her out, they stayed around until she came out of the seizure. The patient went home and then at 07:50 PM she started heavy shallow breathing, was nauseous, dizzy, had a headache, which also happened at the center. Ears became hypersensitive, it was so noisy like loud, but her husband and the paramedics said it wasn't loud but she could hear it, all of her senses were heightened. She had a second seizure and didn't known how long it lasted. Patient had another seizure at 08:25 PM, at 08:40 PM she had another one, at 09:00 PM patient was coming back around and had another seizure and her throat closed up and that's when she went to the hospital, when her throat started to close up. While the patient was in the emergency room (ER) she had another seizure, she had 6 total seizures, she has never had this many before so she knows it was an adverse event to this vaccination. The seizures also increased the patient's heart enzymes- troponin levels. The patient has an EEG, was given 4 baby chewable Aspirin, as she had a mild heart attack. She thought the seizure increased her troponin. The patient mentioned that during the first event at the center, she was so into the seizures, she remembers grabbing her left shoulder, her arm was hurting. She was so into the seizure and trying to throwing up that it didn't dawn on her. The hospital didn't tell her she had a mild heart attack, it just dawned on her because her troponin levels were up mildly and she thought the seizures were triggering something in her heart, not just her seizures. The patient got another headache and was dizzy and had shallowing breathing. Seizures recovered on 28Feb2021. The patient underwent lab tests and procedures which included chest x-ray: normal, it didn't show pneumonia or fluid on the lungs on 27Feb2021, electrocardiogram (EKG): normal on unspecified date, electroencephalogram (EEG): normal on 27Feb2021, troponin: increased on 27Feb2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
65 2021-03-21 cough, malaise, fatigue Presented to ED on 3/14/21 with shortness of breath. She started feeling sick march 6th, with fatigu... Read more
Presented to ED on 3/14/21 with shortness of breath. She started feeling sick march 6th, with fatigue and no appetite. She developed a cough, loss of taste/smell, and then nausea/vomiting. She tested positive for Covid-19 on the 11th. She hasn't been able to hold down meds for the last week. She is having intermittent chest pains which she attributes to not being able to take her cardiac meds. Was started on supplemental oxygen and admitted to hospital. Is still admitted at time of writing.
65 2021-03-21 chills, headache delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and nec... Read more
delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
65 2021-03-22 fatigue Pt notes that her BG levels started to rise about 5 days after the vaccination and remained elevated... Read more
Pt notes that her BG levels started to rise about 5 days after the vaccination and remained elevated for a little over a month later. Her BG readings have been improved since then. She also noted to worsening depression, fatigue, arthralgias associated beyond the initial period of the vaccination.
65 2021-03-24 fatigue, cough Sinus drainage with cough; Sinus drainage with cough; fatigue; Terrible Laryngitis; post nasal drip;... Read more
Sinus drainage with cough; Sinus drainage with cough; fatigue; Terrible Laryngitis; post nasal drip; minimal raspy voice/Mild hoarseness; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 25Feb2021 13:00 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation . Medical history included diabetes mellitus from 2017 (Diabetes diagnosed 4 years ago) , obesity (Obesity has been 10 years or more) , hypersensitivity (Allergies for lifetime) , arthritis (Arthritis diagnosed 20 some years ago) , hypertension from 2011 (High blood pressure diagnosed 10 years ago) , depression (Depression diagnosed 30 years ago) , breast cancer female from 2019 , breast conserving surgery. Concomitant medication included anastrozole (ANASTROZOLE) taken for breast cancer. The patient experienced terrible laryngitis on 28Feb2021 with outcome of not recovered , fatigue on 01Mar2021 with outcome of recovering , sinus drainage with cough on 04Mar2021 09:00 with outcome of not recovered , post nasal drip on 2021 with outcome of unknown , minimal raspy voice/mild hoarseness. All the reported events were considered Important Medical Events. Course of the events: the patient received the vaccine on 25Feb2021, and 3-4 days after, she started getting terrible Laryngitis. It is a little better. She also was fatigued. She did not run a fever. She did develop a little sinus drainage and cough within the last 4 days. She can smell and taste. She called her doctor and he said it is a side effect or reaction to the COVID vaccine. She wanted to know if that was likely or if there had been reports of any others having this reaction. He told her not to get second vaccine. The patient was difficult to understand due to minimal raspy voice. Follow up information has been requested; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-03-28 fever, fatigue, cough, headache, dehydration Dehydration, hospitalized/dehydrated; My fever broke on Monday; Cruel, incapacitating headache/have ... Read more
Dehydration, hospitalized/dehydrated; My fever broke on Monday; Cruel, incapacitating headache/have such a painful headache that I can't eat; Eye pain; Aversion to food/ can't eat; Constant watery diarrhea despite not much food/diarrhea I have so bad; Constant nausea; Utter and complete lassitude/ exhausted; Being in bed, low energy; Stomach upset; Cough; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female consumer patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 04Mar2021 16:00 as a single dose for COVID-19 immunisation. Medical history included, in the 1990's, was diagnosed with systemic sclerosis (limited, used to be called CREST scleroderma), pretty severe Raynaud's syndrome, telangiectases, fatigue and sometimes joint aches. Patient was healthy despite this. Patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. Concomitant medications in two weeks included amlodipine besylate, escitalopram oxalate (LEXAPRO), and clonazepam (KLONOPIN). The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 11Feb2021 04:00 PM and felt unwell but went to work and was fine in 2 days. On 04Mar2021, it was very different, the patient began having symptoms within 4 hours after receiving vaccine at 9 o clock that night. The patient stated "symptoms worsened and it is one week today and I am still sick. My fever broke on Monday. I still have cruel, incapacitating headache, eye pain, aversion to food (extremely weird for me), constant watery diarrhea despite not much food, constant nausea, utter and complete lassitude, dehydration (hospitalized, 2 liters of fluids), pain meds and anti-nausea meds. I have missed a week of work and this is a serious issue for many. I am OK but using precious sick time." Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient stated "I missed whole week to work and I'm still sick. I have had so many different symptoms and some have gone away like my fever is gone but I have such a painful headache that I can't eat, nausea and constant diarrhea, you get the idea. I'm not against the vaccine but I think it would be good if people like me, people that have had my experience know, I hope it's within the normal range, I still don't know I would love to talk to somebody and find out if what I am experiencing is in the normal range, but it's not, people saying they experience so far the kind of the level of being in bed, low energy, unable to eat, fever, headache, stomach upset, I didn't have a cold, I had respiratory, I had a cough that has cleared up. I was hospitalized yesterday with fluids to become hydrated. It's important for us, you know, I mean, I leave the work that not good, people need to be prepared, it should be sick time I think it's important there is a follow up, absolutely. I was very happy I got the vaccine but I am so sick and it's been a week today so, that's why I decided to call and I was in the hospital yesterday, getting fluids dehydrated and I was admitted (reason for hospitalization was not clarified). I wasn't admitted, I was in the hospital for the day on IV fluids, anti-nausea medication, pain medication also, 3 things they gave me in an IV. They sent me home but the diarrhea I have so bad, I'm exhausted, but I have to spent all my time in the toilet, I thought today might be, I might wake up it would be healing today but I'm still pretty sick." Outcome of fever and cough was recovered, and of remaining events was not recovered. The patient underwent COVID-19 virus test via nasal swab on 03Mar2021 with negative result. Information about lot/batch number has been requested.
65 2021-03-28 fever, chills, fatigue feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm fe... Read more
feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm felt mildly painful as injection went in; severe chills; fever; fatigue; restless sleep; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 65-years-old via an unspecified route of administration on 08Mar2021 08:15 (lot number: EN6203) as single dose for covid-19 immunisation. Medical history included covid-19 (covid prior vaccination: yes) from 10Jan2021 to an unknown date. There were no known allergies. Concomitant medication included acetaminophen taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 65-years-old, administered on the left arm on 15Feb2021 08:15 (lot number: EL9264) for covid-19 immunisation and experienced very painful injection site, chills, fever and fatigue. The patient reported that when she had her second vaccine on 08Mar2021, her arm felt mildly painful as injection went in, as though never healed from previous shot. This time, within 3 hours of vaccine, she began to feel fatigue, then began to experience chills and fever. She drank plenty of fluids, and took acetaminophen about 6 hrs after injection. In the evening her temp was up to 101.2 (her normal 97.2) and she took Acetaminophen at bedtime. Had very restless sleep, and at 5 AM on 09Mar2021, she got up feeling sick to her stomach ended up fainting onto bathroom floor. Luckily uninjured, and felt better upon "coming to". She was very fatigued rest of day, then normal next day. The patient underwent lab tests and procedures which included body temperature: 101.2 on 08Mar2021. No treatment was received for the events. The patient recovered from the events on an unspecified date.; Sender's Comments: Linked Report(s) : Same reporter,patient,product/ 2nd dose;US-PFIZER INC-2021269674 Same reporter,patient,product/ 2nd dose
65 2021-03-28 cough received 1st dose 1/15/21, complaints of cough, nausea, diarrhea started 1/20/2021. Presented to th... Read more
received 1st dose 1/15/21, complaints of cough, nausea, diarrhea started 1/20/2021. Presented to the ED on 1/24/2021 with the same symptoms; COVID-19 test came back +. Per ED physician, "On repeat evaluation she is resting comfortably in the room. O2 saturation remains in the low 90s on room air. Vital signs otherwise stable. Her Abbott Covid test was positive. CBC does show leukopenia otherwise unremarkable. BMP shows mildly elevated creatinine, no other significant abnormalities. Chest x-ray unremarkable. Patient was ambulated with pulse oximeter and O2 saturation dropped into the mid 80s. Recommended she be admitted and she agrees. Case discussed with hospitalist who agrees to meet the patient. We will give her Decadron here". Admitted to the RCU where she received ceftriaxone and azithromycin for bacterial pneumonia. Transferred to healthcare facility on 2/1/2021.
65 2021-03-28 sweating, chills, fatigue then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feelin... Read more
then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
65 2021-03-29 fatigue, headache Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous repor... Read more
Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous report from a contactable 65-year-old female consumer reported for herself. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose (at the age of 65 years old) for covid-19 immunisation. Medical history included osteoarthritis due to car wrecks in younger years, migraine headaches, muscle spasms in back, covid-19 from Jul2020 to an unknown date (still on oxygen from being hospitalized in July with Covid and still get really tired, was home for a week and a half before being transported to hospital for 2 weeks, and received a plasma transfusion). The patient previously took codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, lisinopril and experienced drug hypersensitivity. On 21Feb2021 17:00, the patient experienced headache, tightness in chest, legs hurting from knees down, super tired (felt almost like he did when she had Covid infection and she was still on oxygen from being hospitalized in July with Covid). The outcome of the reported events was recovered. There was no treatment reported. Since the vaccination, the patient had not been tested for COVID-19.
65 2021-03-30 throat irritation, headache, fatigue Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in ... Read more
Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in the throat; Headache; Dizzy; couldn't think clearly/her thinking wasn't clear; Confused; sensation in her chest; weak; fatigued; she had a full tongue which effecting her talking; tingling in her lips; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot Number: EN6198; Expiration Date: Jun2021), as single dose in left shoulder on 04Mar2021 at noon for COVID-19 immunisation. Medical history included Hashimoto's disease from May2012 and ongoing (autoimmune condition), ongoing undifferentiated connective tissue disease (UCTD) (autoimmune condition, unsure when diagnosed, started with polymyalgia rheumatica, then it went to rheumatoid arthritis (RA), then it went between Lupus and undifferentiated connective tissue disease), hospitalization: she had to go hospital twice in last 4 months, one was for Amlodipine which has polyethylene glycol and another time for Lisinopril as another blood pressure medication, she had 2 mild anaphylactic reactions in the last 4 months from amlodipine and Lisinopril, patient thought they all have PEG in the ingredients; underwent colonoscopy unknown results. There were no concomitant medications. On 04Mar2021 the patient experienced anaphylactic reaction, gasping for air, headache, dizzy, could not think clearly/her thinking was not clear, tongue swelling, swollen lips, throat closing/restriction in her throat, confused , sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips. Course of events was as follows: The patient drove two hours to get the vaccine. The patient was vaccinated on 04Mar2021 at noon. The reaction started immediately, the caller had a severe headache within seconds, a little bit of sensation in her chest. The patient's thoughts were getting mixed up, she was not thinking clearly. This was one of first things that happened. The patient stumbled a little bit and the nurses were there around her and said she better sit down now. Then the sensation in her throat was starting to feel like it was closing up, her lips were swollen; so she would say she was a little bit confused. The patient started getting dizzy and her thinking was not clear, her tongue swelled, she had a full tongue which effecting her talking, she was gasping for air, she needed a moment to regulate her breathing. In regards to swollen lips she added at first she had a tickle in the throat, tingling in her lips, restriction in her throat, then she started slurring her words before the ambulance got there. On site they responded and watched her because she did not know if the symptoms were going to get worse. The paramedics gave the caller oxygen and an IV, since she had a mild experience she wanted to see what she did not take any medications before taking the vaccine so she could see what it would do, she did not take an ibuprofen or Tylenol. Patient commented, she knew it was not recommended, but some people do it. The patient mentioned started speaking very badly and very fast, she started gulping for air, and was informed the histamines are hitting her. She felt like she was going to faint, she thought if she was able to count back from ten she was going to be knocked out. Once she counted back she started to feel better. Like she would not faint. She did not faint often. She mentioned counting backwards from ten when getting a colonoscopy or something like don't get passed five and then knocked out, so she knows the sensation that can occur. After 1.5 hours they decided to call the emergency number and that was when the ambulance came. The ambulance service was the one who did everything for the patient. Because the patient got in the ambulance, they required her to go to the hospital, she was in a bed in the hall, by the time her doctor had looked at her, her throat had opened up and was feeling reasonably well after an hour an half. Confirmed she was not admitted just in the Emergency Room. On 04Mar202 the patient was at the hospital and was gasping for breath. The patient was on an IV and they gave her 125 mg of Solu-Medrol, 50 mg of Benadryl, and 5 mg of nausea medicine, phedrol the caller thought it was called. They did a good job and that helped the patient down from the most severe symptoms and she wanted to report her symptoms. The patient has been looking around and she thought this reaction it was from the polyethylene glycol. She mentioned historically she had a minor reaction. She had to go hospital twice in last four months. One was for Amlodipine which has polyethylene glycol and another time for Lisinopril which is another blood pressure medication. She confirmed she visited the emergency room for all 3 of these cases. The patient was still very confused on 09Mar2021 and over the weekend, she had to rest, she was weak and fatigued. On 09Mar2021 it was first real day she went back to work. She worked and asked her brother to watch out for her. On 10Mar2021 she was starting to feel a little bit better as regarded anaphylactic reaction, she has recovered with residual effects from the anaphylactic reaction. Confusion was improved but stull a concern. The outcome of anaphylactic reaction was recovered with sequelae, of headache, swollen lips, confused was recovering, of gasping for air, dizzy, could not think clearly/her thinking was not clear, tongue swelling, throat closing/restriction in her throat, sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips was unknown. Patient asked if there was a conclusion about the PEG and her anaphylactic reaction. Her second dose was scheduled on 25Mar2021. Patient stated that her PCP and the CDC recommend to not get the second dose. Caller wanted to know if the anaphylaxis could be worse in the second dose. The patient wanted to know if she should she get the next dose. She was very concerned about COVID as well but did not know if it's worth her risking her life. Patient wanted to know if she can get the Johnson and Johnson vaccine after a certain amount of time after receiving the Pfizer COVID 19 vaccine, caller cannot get the second dose of the Pfizer COVID vaccine due to a reaction. As of 12Mar2021 patent stated she does not wish to be contacted any further. A Product Complaint was filed.
65 2021-03-30 cough, fever, headache, pneumonia bilateral pneumonia; severe headaches; bronchial cough; low grade fever; body aches; This is a spont... Read more
bilateral pneumonia; severe headaches; bronchial cough; low grade fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202; expiry date: not known), via an unspecified route of administration, administered in arm right on 24Feb2021 11:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 21Dec2020 with reported symptoms of bilateral pneumonia, severe headaches, bronchial cough, low grade fever, and body aches. The patient is not pregnant. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT); and codeine phosphate, guaifenesin (CODEINE GUAIFENESIN). The patient previously took gabapentine and experienced allergies. No other vaccine received in four weeks. Clinical course was reported as follows: she tested positive for COVID-19 on 21Dec2020 and recovered. She had bilateral pneumonia, severe headaches with bronchial cough, low grade fever and body aches which lasted five weeks. She was fully recovered but had intermittent mild symptoms lingering. On 25Feb2021 08:00, within 24 hours of getting the first vaccine, she developed all these symptoms again, but they were severe again and had to start prescriptions meds again daily to manage them and she still experiencing them now. She was due to have her second vaccine on Wednesday, 17Mar2021 and she was considering postponing it after her primary care (PC) doctor suggested she did so till her symptoms subsided. These adverse events resulted in doctor/other healthcare professional office/clinic visit. The patient had COVID prior vaccination and had not tested post vaccination. The patient had not recovered from all the events. No follow-up attempts are possible. No further information is expected.
65 2021-03-31 malaise, fatigue Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every ni... Read more
Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day; like she had arthritis; Her hair has been falling out/Hair loss; Joint pain; Fingers were frozen; Couldn't eat; barely hydrated; Pain she had in her fingers/ Her toes hurt when she walks; It was hard for her to cook, wash clothes, and do anything; This is a spontaneous report from a contactable Nurse (Patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscular, administered in Deltoid Left on 16Feb2021, 13:15 (Batch/Lot Number: elg267) as SINGLE DOSE for covid-19 immunisation, at 65 years old. Medical history included ongoing Irritable bowel syndrome, she was diagnosed with IBS (irritable bowel syndrome) 15 years ago (unspecified date); Blood pressure high from 2000 and ongoing, High cholesterol from an unknown date (she has had high cholesterol for about 4-5 years or longer), depression from an unknown date (she was diagnosed with depression in her 30s after a car accident. She said she has had post-traumatic stress and depression for years); type 2 diabetes mellitus from an unknown date (she has had Type 2 Diabetes for a while. She said she couldn't take the diabetes medicine. She said she didn't say much to her doctor about the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now); post-traumatic stress from an unknown date. Patient received the first dose of BNT162B2 on 29Jan2021 13:15, 65 years old, (lot number el9262) for covid-19 immunisation and experienced back pain, fatigue, alopecia, malaise, arthralgia, nausea, vomiting, feeling abnormal, musculoskeletal stiffness, arthritis, illness, hypersomnia and fluid intake reduced. There were no concomitant medications. The patient had her second COVID-19 vaccine on 23Feb2021. On 23Feb2021, patient experienced feeling unwell. She has never been so sick; and severe fatigue/fatigue extreme. She got her second COVID-19 Vaccine shot her tiredness was worse. Reported with the regular flu vaccine she had felt bad for maybe 3-4 days, but nothing like how she felt after getting the COVID-19 Vaccine. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. Reported it had been 10-12 days since she had her second COVID-19 Vaccine, and she was still so tired. She is tired all of the time. Her tiredness was worse. She was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad; she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she woke up at 5:30AM today. She said she was exhausted from just going to a doctor's appointment. On 25Feb2021, patient experienced nausea and vomiting. She said she had severe nausea and vomiting, clarifying that the nausea and vomiting lasted 2 weeks. Treatment was Phenergan Syrup 6.25mg/5ml every 6 hours, as needed. She said the Phenergan was originally prescribed for IBS. She said the Phenergan Syrup was dispensed in a pharmacy bottle, and didn't have a NDC, Lot, and Expiration Date. She said the Phenergan prescription label only had a printed barcode. Zofran 4mg tablet, as needed, three times a day. On an unspecified date in Feb2021, the patient experienced her hair has been falling out / Hair loss. She reported that her symptoms while a little better she is still tired all of the time, her hair is still falling out reporting, "If I roll it up in a clump its the size of a golf ball". She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. Hair Loss Treatment: She said the first thing she started taking was 1 Vitafusion Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support. She stated she also took 2 Vitafusion Vitamin C 282mg Gummies a day. She said the product label said to take 3 Vitafusion Vitamin C 282mg Gummies per day, but she only takes 2 Gummies; Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. She said her Fingers were frozen in a half closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to unstick; Couldn't eat and was barely hydrated. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed; Pain she had in her fingers/ Her toes hurt when she walks, she never hand been like this before. She said every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were sore. Treatment: Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6 day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and is to take 1 Prednisone 50mg tablet a day for 6 days; It was hard for her to cook, ash clothes, and do anything. She said she was just laying bed with an ice pack, or a heat pack, and taking pain pills. She said she told her doctor she had called the Health Department, and the CDC. She said the Health Department didn't want to tell her anything, and the CDC will only talk with someone who has had an anaphylactic reaction to the COVID-19 Vaccine. She said she asked her doctor how long she was going to have the side effects. She said her doctor said that all of her patients who had any reaction to the COVID-19 Vaccine, had mostly had called into her office to ask about the COVID-19 Vaccine side effects, and most of the patients COVID-19 Vaccine side effects resolved in a week. She said her doctor said not one of her other patients had ever told her about the kind of side effects she was having. She said her doctor told her she must be in the 2% group and to call Pfizer to report her side effects. She asked how long the events would last and what can she take. The patient underwent lab tests and procedures which included cardiac stress test: all was good right now (unspecified date). Therapeutic measures were taken as a result of her hair has been falling out/hair loss, like she had arthritis, nausea, vomiting, joint pain (arthralgia). Events did not require visit to emergency room. Outcome of the event hair loss was not recovered; outcome of feeling unwell, severe fatigue/exhausted, joint pain was recovering; nausea and vomiting was recovered on an unspecified date; and outcome of all other events was unknown. The patient considered the events as related. The reporter considered the events as serious - medically significant.; Sender's Comments: Based on a temporal association and known drug safety profile, the causal association between the events and the suspect drug BNT162B2 cannot be totally excluded. Possible contribution from patient's underlying medical condition is also considered. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
65 2021-04-01 fatigue, malaise Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shou... Read more
Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers; didn't feel good; her fingers were frozen in a half closed position when she woke up in the morning; her body ached like she had arthritis; she couldn't eat and was barely hydrated; Hair loss; she couldn't eat and was barely hydrated; Tiredness/Fatigue extreme; Backache; "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning; sick; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: el9262, Expiration Date: Unknown) via intramuscular route of administration in left deltoid on 29Jan2021 (at the age of 65-year-old) at 13:15 as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: Unknown) via an unspecified route of administration on 23Feb2021 as a single dose, both the doses for COVID-19 immunization. The patient medical history included Irritable bowel syndrome diagnosed 15 years ago (ongoing), ongoing Blood pressure high from an unknown date in 2000, high cholesterol for about 4-5 years or longer, depression (diagnosed in her 30s after a car accident), Type 2 diabetes mellitus (she couldn't take the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now), post-traumatic stress, she was bedridden for 2 weeks on an unknown date in feb2021 (only able to get up to go to the bathroom), it was hard for her to cook, wash clothes, and do anything on an unknown date in Feb2021. The patient underwent stress tests, and all was good right now. The patient did not receive any additional vaccines administered on same date of the Pfizer Suspect was none. The concomitant medication was not reported. The patient previously took historical vaccine, flu vaccine on an unknown date for immunisation and felt bad for 3-4 days. It was reported that after first dose patient has been so sick. The patient experienced back pain on 29Jan2021. She reports that starting the next day that was on 30Jan2021, she has experienced severe fatigue extreme and tiredness. She reports that her symptoms while a little better she is still tired all of the time. She reports "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning on an unknown date in Jan2021. Caller also reports, my joints are in severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers on an unknown date in Feb2021. My fingers are closed, and I can't straighten them out when I wake up". The patient put ice on her back and took pain pills and stuff. It was reported that patient had undergone back tests and result was not reported. The patient reported that she took she took Norco, or Hydrocodone/Acetaminophen 10mg/325mg. said her Norco 10mg/325mg prescription was for 1 Norco 10mg/325mg tablet every 6 hours, as needed, for pain. She said she normally would take 1 Norco 10mg/325mg tablet during the day, and another Norco 10mg/325mg tablet at bedtime. She said after her first COVID-19 Vaccine dose, she had been taking a Norco 10mg/325mg tablet every 6 hours. She said she also took a muscle relaxer, Tizanidine 4mg tablet. She said she took 1 Tizanidine 4mg tablet with the Norco 10mg/325mg tablet, three times a day. She said her backache felt like a belt across her lower back. She said when she has a backache, she gets off her feet, and puts her legs up on a pillow to take pressure off of her back. She said she rested, as well, but tried to do stuff around her house. She said she did have some tests on her back, and she had a fractured facet in her lower spine around the L1 vertebrae. She said she had to have some more tests done on her back. She said the backache she experienced after getting her COVID-19 Vaccine was not normal backache pain. It was Reported about 5-6 days after getting her first COVID-19 Vaccine, that was on an unknown date in Feb2021, her hair started falling out and the severity was explained by patient as "If I roll it up in a clump it's the size of a golf ball". She clarified she would brush her hair and would end up having hair everywhere (in her brush, on the counter, and floor). She said the day after she first noticed her hair falling out, she had even more hair fall out than normal. She said she was worried about her hair falling out and took Biotin and vitamins. She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. The patient took 1 vitamin Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support (UPC Number: 2791700026, Lot Number: WA01802798, Expiration Date: Dec2021). She stated she also took 2 Vitamin C 282mg Gummies (UPC Number: 2791702071, Lot Number: WAO1887038, Expiration Date: Jan2022) a day. She said the product label said to take 3 Vitamin C 282mg Gummies. She stated she also takes 2 Calcium (UPC Number: 2791701951, Lot Number: YY01548358, Expiration Date: Jun2022) 500mg per day. Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. Reported she was still tired. She clarified after she got her first COVID-19 Vaccine, she had felt tired for a few days with her back bothering her. She said she would get up and take her pain medicine, go to the bathroom, and get something to drink and go back to bed. She said she had felt a little better but wanted to take a nap every day. She said after she got her second COVID-19 Vaccine shot her tiredness was worse. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She clarified when she got home from her second COVID-19 Vaccine she was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad, she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she was exhausted from just going to a doctor's appointment. Reported every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were frozen in a half-closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to "unstick." Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and was to take 1 Prednisone 50mg tablet a day for 6 days. Reported she had severe nausea and vomiting on 25Feb2021 and clarified that the nausea and vomiting lasted 2 weeks. She said she took Phenergan and Zofran around the clock. She said she couldn't eat and was barely hydrated. Zofran 4mg tablet (NDC Number: 65862-187-30, Lot Number: OND420010-A, Expiration Date: Jun2024), as needed, three times a day. She said the Zofran was dispensed in a white manufacturer's bottle. Reported she needed to have some regular blood work done. The seriousness of the events Backache, Tiredness/Fatigue extreme, Hair loss, Feeling unwell, Joint pain, Nausea and Vomiting were reported as serious (medically significant) by the reporter. The final outcome of the events Backache, Tiredness/Fatigue extreme, Hair loss was not recovered; Feeling unwell, severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers, Nausea, Vomiting was recovering; didn't feel good, her fingers were frozen in a half-closed position when she woke up in the morning, her body ached like she had arthritis, she couldn't eat and was barely hydrated, sick and "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
65 2021-04-04 headache After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in lef... Read more
After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in left foot was painful and very high anxiety. I started exp cramping in my lower arms I have been to ER, PCP, Ophthalmologist and Neurologist. I'm having terrible headaches as well. The Opthamologist applied eye drops that cause me to go to ER on 4/2 had blood work, checked pressures in eyes, prescribed medications nausea/dizziness, pain in my head and IV for low sodium.
65 2021-04-06 chills, headache, fatigue, fever Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; Th... Read more
Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Mar2021 09:30 am (Batch/Lot Number: En6204) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications within 2 weeks of vaccination were not unspecified. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received cefaclor (CECLOR) and experience allergies, and also received first dose of BNT162B2 (Lot number= En6200) on 25Feb2021 09:30 AM at single dose at left arm for COVID-19 immunization. The patient experienced nausea, fever, chills, headache, tired and diarrhea which led to loss of fluids and low blood pressure in Mar2021 08:00 PM with outcome of recovering. The adverse events resulted in hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage, emergency room/department or urgent care. Patient received treatments for the events included fluids, medicine, partial colon removal. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19: negative in Mar2021. Additional information has been requested.
65 2021-04-07 chills, headache, malaise, fatigue, fever Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and musc... Read more
Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and muscles throughout body; aching joints and muscles throughout body; Chills; felt "heavy & on-fire" though cool to the touch (neuropathy); diarrhea; Headache; lower GI distress; muscle cramping all over body; Low-grade fever/temperature 100.9; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included osteoarthritis and upper gastrointestinal (GI) distress. Concomitant medications included omeprazole (PRILOSEC) taken for upper gastrointestinal (GI) distress, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (CAL) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number: EL3249) on 27Jan2021 04:30 PM at left arm. Other vaccine in four weeks reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products reported as no. These symptoms persisted for 24hours: on 18Mar2021 the patient was awoke midnight with chills, severe lower GI distress, diarrhea, head ache, muscle cramping all over body, legs felt heavy and on-fire though cool to the touch; temperature 100.9. Second 24 hours: the patient had low-grade fever, diarrhea, head ache, aching joints and muscles throughout body, continued lower GI distress. After 48 hours: the patient had temperature normal, sore achy body, head ache, fatigue. Consumed only water during first 72 hours then resumed liquids (broth, ginger ale) intake. Effectively treated diarrhea with loperamide hydrochloride (IMMODIUM); dicycloverine hydrochloride (BENTYL) for lower GI distress; resumed omeprazole (PRILOSEC) for upper GI distress. The patient returned to work on 23Mar2021 half-day, 24Mar2021 full-day still not feeling well. On 24Mar2021 during the night, legs were restless from hips down, felt "heavy and on-fire" though cool to the touch (Neuropathy) was similar to first night on 18Mar2021. On 26Mar2021, all symptoms have disappeared and the patient felt good, again she was in very good general health, active, appropriate weight, never ill. Events reported as non-serious. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event fever was recovered on 20Mar2021, of other events was recovered on 26Mar2021.
65 2021-04-07 cough anaphylactic; reactions are allergic; Terrible airway swelling, it felt like breathing through a str... Read more
anaphylactic; reactions are allergic; Terrible airway swelling, it felt like breathing through a straw, narrowing airway; Sensation of throat closure/narrowing of airway; significant shortness of breath/difficult to breath like through a straw; Pain in both lymph nodes, under both the armpit; Pain in both breasts; Dry cough; Itching, airway/trachea itchy; Hoarseness; Dizziness; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the left deltoid on 15Feb2021 at 15:30 as a single dose for protection against Covid. Medical history included ongoing obesity as she gains and loses it, ongoing hypertension, ongoing asthma (at 59 she was bumped up to moderate degree asthma), ongoing significant food allergies, was born with and had ongoing eczema so she was allergic to milk (was given soy milk since she could not tolerate milk, when she drank milk, it produced phlegm/caused increase in mucus, ongoing significant environmental allergies wherein she would have allergies in the fall, from August through September and would have sneezing, congestion and itchy watery eyes. The patient also had a history of getting bronchitis but has not had it for a long time. The patient got stung by a bee when she was 40ish and her upper thigh got red, itchy and it lasted for 10 days and she and no other symptoms and was now careful around bees. The patient reacts to the smoky matches that blow out and make smoke, from the sulfa in the matches, fireplaces, wood burning and firepits. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, start and stop date were not reported and fluticasone (manufacturer unknown) taken for asthma and allergies, start and stop date were not reported. The patient was on significant medications for her asthma, allergies and blood pressure. The patient previously got a flu shot at the end of Oct2020. The patient also previously took Aleve in her early 40's and was taking them for a neck injury for 2-3 months and at the end of the treatment she broke out in a rash. The patient also previously took aspirin 3 years ago and broke out in a rash. The patient also has an albuterol inhaler but has not taken it for years. The patient was careful, handwashing normally, wipes the shopping carts as they are germy. The patient stated that after receiving the vaccine, one main event was terrible airway swelling, itching and it was difficult to breathe. The terrible airway swelling felt like breathing through a straw and narrowing airway. She stated that it started 18.5 hours after the vaccine, on 16Feb2021 at 10 am and lasted for 4 hours between 10 to 2 pm. The patient also had itching wherein her airway and trachea were itchy which also started on 16Feb2021 at 10 am to 2 pm. The patient experienced narrowing of airway and sensation of throat closure also between 10 am to 2 pm. The patient also experienced that it was difficult to breathe but she did not feel like she needed to go to the hospital. If it got any worse she would gave went to the emergency department. She stated that she was sitting up, walking around and she would have had a significant shortness of breath and she was trying to wait it out. It was difficult to breath like through a straw which also started from 10 am to 2pm. She did not feel like she wanted to walk or do daily activities. She was on the phone with her mother and her mother could hear her difficulty in talking and her heavy breathing. The patient also experienced pain in both lymph nodes, under both armpits and pain in both breasts which started also on 16Feb2021 at 10 am and lasted for 24 hours the 10 am the next day. The patient had dizziness which started about noon and when she woke up the next day it as gone which she considered as medically significant since she is never dizzy and it was not due to her blood pressure and she has been on pills for a long time. The patient had dry cough and hoarseness also on 16Feb2021 from 10 am to 2 pm. The patient was afraid to take the second vaccine and she spoke to her pulmonologist who knows her history and was told that she would benefit. She thought that if she felt bad, she would go to the emergency room if it got worse but it did not. The patient stated that she thinks these reactions are allergic, the itching and narrowing of throat can be anaphylactic. The patient did not require any medical intervention and was not seen in the emergency department and was not hospitalized. The events lasted for 4 hours and stayed at that level. The patient did not get any treatment and it went away. The outcome of the events terrible airway swelling, it felt like breathing through a straw, narrowing airway, Dry cough, Itching, airway/trachea itchy, Hoarseness, Sensation of throat closure/narrowing of airway, reactions are allergic and anaphylactic was recovered on 16Feb2021 at 14:00. The outcome of dizziness was recovered on 17Feb2021 and the outcome of pain in both lymph nodes, under both the armpit and pain in both breasts on 17Feb2021 at 10:00. The patient reported that the events were considered as medically significant. The relatedness of the drug to the reactions from primary source reporter (method of assessment: Global Introspection) for the events was related.; Sender's Comments: A contributory role of vaccine BNT162B2 to reported events cannot be fully excluded since it is part of the product safety profile. Potential contributors include patient's advanced age, as well as underlying obesity, hypertension, asthma, eczema, multiple allergies and other co-morbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
65 2021-04-07 throat pain, malaise, respiratory tract congestion she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling... Read more
she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling in throat created an infection; throat feels dry; a lot of congestion in chest and in the lobes; a lot of congestion in chest and in the lobes; Lymph nodes in throat swelled up; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Lot Number: EN6198, NDC number: 59267100001, Expiry date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 65-year-old) at single dose for COVID-19 immunization. Medical history included ongoing asthma diagnosed about 40 years ago in 1981. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for asthma had for a number of years, keeps them on hand; and salbutamol sulfate (VENTOLIN CR) taken for asthma, had for a number of years. The patient got the first shot and she have asthma but forgot to tell them that she has asthma and no one asked her first. The patient got pretty sick on unspecified date and she is trying to figure out if this could be from the vaccine. On 06Mar2021, her lymph nodes in her throat swelled up and her throat was raw, painful, super red and she could hardly talk, it also created a lot of congestion in chest- the lobes. The swelling in throat created an infection on unspecified date. She wound up going to the doctor and they prescribed her an antibiotic which cleared the infection in her throat. Her symptoms started two days after she received the shot. She is supposed to get the second shot on Thursday 25Mar2021 and that's why she is calling to find out information on what other people reported as far as asthma patients. She is debating on getting the second shot. Initially caller states that for the most part, it cleared up and went away about three days ago, but then explains it is gradually getting better. Every once in a while, her throat feels dry and raw, but she drinks water and it feels better. At first, she did not want to really talk. She has asthma, the congestion never really goes away and it didn't really improve this time after prednisone like it usually does. She did not feel good on Friday, but on Saturday it got bad. Her side effects have improved from what they were then. The patient recovered from the event swelling in throat created an infection on unspecified date. The outcome of got pretty sick and throat feels dry was unknown and the outcome of the remaining events was recovering. No follow-up attempts are possible. No further information is expected.
65 2021-04-09 fatigue Possibly an autoimmune disease; Possibly Fatigue; Experiencing exacerbation of pre-existing symptoms... Read more
Possibly an autoimmune disease; Possibly Fatigue; Experiencing exacerbation of pre-existing symptoms; This is a spontaneous report from a contactable consumer via the medical information team. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient exacerbation of pre-existing symptoms since she had the vaccine first dose. The reporter did not know the details of her pre-existing symptoms but stated that fatigue was included and possibly an autoimmune disease. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
65 2021-04-09 malaise, throat pain, headache ischemic colitis; sore throat; constant headaches; ears hurt; dizzy; generally not feeling well; Thi... Read more
ischemic colitis; sore throat; constant headaches; ears hurt; dizzy; generally not feeling well; This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 65-year-old, via an unspecified route of administration, administered in left arm on 04Feb2021 (Lot Number: EL3246) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included the patient having known allergies (unspecified). Concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EL0140) at the age of 65-year-old, via an unspecified route of administration at the left arm on 14Jan2021 at 04:00 PM for Covid-19 immunization. On 01Mar2021, the patient experienced ischemic colitis, constant headaches, ears hurt, dizzy, generally not feeling well, and sore throat. The patient was hospitalized on an unspecified date due to the events for 5 days. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of ischemic colitis, which may likely represent intercurrent medical condition. Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the other reported events due to temporal relationship There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-04-10 chills, fatigue, headache Vaccine given on 3/21/2021 - Chills, headaches , weakness and fatigue started on 3/22/2021- no fever... Read more
Vaccine given on 3/21/2021 - Chills, headaches , weakness and fatigue started on 3/22/2021- no fever. Weakness,chills and fatigue and headaches progressed until 4/01/2021 when patient experienced complete weakness in left arm and leg and unable to stand or walk. Prior to 2nd dose, patient was recovering from a stroke and was beginning to walk with assistance and a cane. After April 1, 2021, patient is unable to stand or walk. Chills, headaches weakness and fatigue continue as of April 11, 2021
65 2021-04-14 pneumonia Death R06.02 - Shortness of breath J18.9 - Pneumonia
65 2021-04-18 fever High fever, severe night sweats, blood clots in lungs
65 2021-04-20 throat pain, respiratory tract congestion, fatigue, fever, headache, cough Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weaknes... Read more
Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weakness, & fatigue that had started 4/4/21 and diagnosed w/COVID-19 (4/10/21). She had just received 2nd vaccine (3/27/21), but had been exposed to COVID-19 the following day from a relative. She was discharged w/dexamethasone and pulse oximeter. Symptoms had continued to worsen and returned to ED where she was admitted for acute hypoxemic respiratory failure and tachycardia secondary to COVID pneumonia requiring steroids, remdesivir, oxygen, but unfortunately succumbed to her illness (4/18/21) given condition critical and prognosis poor.
65 2021-04-23 fatigue Left eyelid swollen and purple; Sharp pain on her left eyelid; Very weak and fatigued; Very weak and... Read more
Left eyelid swollen and purple; Sharp pain on her left eyelid; Very weak and fatigued; Very weak and fatigued; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered in Deltoid Right on 28-JAN-2021 16:00 at single dose for COVID-19 immunisation. Patient medical history included COVID-19 Virus and diabetes runs in family, but she just had a physical. Patient did not have diabetes. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29 Jan2021, the patient had experienced very weak and fatigued very weak and fatigued. On 30 Jan 2021, the patient had experienced sharp pain on her left eyelid. On 31 Jan 2021, the patient had experienced left eyelid swollen and purple. Next COVID-19 Vaccine in 18Feb2021. The patient did not received other medications within 2 weeks of vaccination. Patient was not on any prescription or over the counter medications. She took Eye Relief Eye drops and Benadryl for her eyelid swelling. Benadryl and Eye Relief eye drops did not do anything for swollen eyelid. Provided, lab-1451-1.0, on back of fact sheet for recipients and caregivers. On an unspecified date in 2021 the events sharp pain on her left eyelid and very weak and fatigued was resolved. At the time of reporting, the outcome of the event left eyelid swollen and purple was not recovered..
65 2021-04-23 headache Prolonged headaches; nausea; abdominal pain; This is a spontaneous report from a contactable nurse (... Read more
Prolonged headaches; nausea; abdominal pain; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN 5318), dose 1 via an unspecified route of administration, administered in left upper arm on 25Jan2021 at 12:45 as single dose for covid-19 immunization. Medical history included cardiac disorder, hypertension, type 2 diabetes mellitus, hypothyroidism, drug hypersensitivity and allergies to Ace inhibitors. Concomitant medication was not reported. No other vaccine in four weeks. No other medications in two weeks. On 25Jan2021, at 04:00 pm patient experienced prolonged headaches, nausea and abdominal pain. On 01Feb2021, the patient underwent lab tests and procedures which included sars-cov-2 test as negative. No covid prior vaccination. The treatment medications for the events included Zofran. The patient was recovered from the all events.
65 2021-04-24 sweating, malaise, lethargy blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; ... Read more
blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; clammy and lethargic; clammy and lethargic; respiratory rate was 8; This is a spontaneous report from a contactable nurse (husband). A 65-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EW0153), intramuscular, administered in Arm Right on 08Apr2021 12:30 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at Administration facility. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included diabetes, hypertension, depression, and known allergy to sulfa. The patient was not pregnant. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; and BP (blood pressure) meds, ECT therapy. The reporter stated that he and his wife came around at 12:30 (08Apr2021) and got her first dose of COVID vaccine. They waited in observation for 15 minutes. They went to go eat after the shot and he stopped to get gas and his wife stated "I don't feel right and I am breaking out in a sweat." So, he just came back over here to the vaccine site. When nurse approached the car, the patient in the passenger seat appeared diaphoretic, clammy and lethargic. She was responsive oriented to four spheres and denied pain. She said "I just don't feel right." Pulse rate was 63, respiratory rate was 8, BP was 120/60 O2 saturation 97%. The patient stated "I am a diabetic and blood sugar was 140 this am." She is on insulin and BP meds her spouse stated, Advanced EMT on site checking vitals. Epi 0.3 was given in right thigh per EMT and patient was transported to ER via ambulance. All adverse events started on 08Apr2021 01:15 PM. The adverse events resulted in Emergency room/department or urgent care. The patient received corrective treatment for the reported adverse events. Outcome of the events was recovering. The patient had no COVID prior to administration of bnt162b2 and was not tested for COVID post vaccination.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
65 2021-04-26 cough, chills, throat pain emphysema; wheeze from the pollen; allergies were not exacerbating but started the last few days; wh... Read more
emphysema; wheeze from the pollen; allergies were not exacerbating but started the last few days; wheezing cough; she had a sore throat; agitation; chills; anxiety; tight, shallow, and labored breathing/troubles breathing/Difficulty breathing/ has to yawn a lot to get the air in; tight, shallow, and labored breathing/troubles breathing/Difficulty breathing/ has to yawn a lot to get the air in; tightness in her chest; felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7534), via an unspecified route of administration, administered in Left Arm on 23Mar2021 19:00 as single dose for COVID-19 immunisation. Medical history included ongoing laryngopharyngeal reflux diagnosed about 5 years ago, ongoing anxiety, usually happens during stressful circumstances; diagnosed about 20 years ago and she had had the sensation of labored breathing, dry mouth, and accelerated heart rate then yes for work like with public speaking; sensitive: Sulfa drugs, aesthetic filler in her face and allergic reaction Hyaluronic acid filler collagen and she doesn't smoke and drink. Family history included daughter was diagnosed with psychotic episode and diagnosed with mental illness and it was stressful getting that under control and she was sensitive to medication and surgical procedures she doesn't tolerate narcotics. Concomitant medication included clonazepam (KLONOPIN). She reported that she was prescribed .125 of clonazepam and it was a dissolvable sublingual and she doesn't use it frequently as she has read about reliance and potentially addictive and she will take a walk or watch a boring video to try to get her mind off it. The patient previously took oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET) and she was sensitive to Percocet; and darvocet and experienced sensitive to Darvocet post surgery; and codeine, and vicodin and was sensitive to both drugs, advil and causes her stomach to be upset, shingles vaccine, HPV vaccine, chicken pox vaccine and got 1 pox from that about 15 years ago when it first came out. The only post-surgical medicine pain reliever she can take was Tramadol and more often than not she doesn't have to do anything beyond Tylenol extra strength. On 24Mar2021, 04:00, the patient experienced extreme chills, and anxiety accompanied with tight, shallow, and labored breathing. She had troubled breathing due to this. She mentioned that she went to the emergency room (ER) that morning. On 27Mar2021, the patient had emphysema and agitation. On 26Mar2021, early in the morning, she had the breathing issue that she mentioned first concurrent with agitation and anxiety like at same time with the extreme chills. The sensation of agitation was all combined together, it like hit out of the blue while she was getting ready to go to sleep. She stated that at 4am it hit her with a sudden bout of extreme chills and at the same time a sense of anxiety, it felt like she hit a wall and couldn't get a full breath. She stays up late but wasn't doing anything anxiety provoking, she thought she was reading recipes. She sat to calm herself as she was not sure if it was a reaction or anxiety at the initial reaction fueling it further so she tried to sort of lower everything in her system and was concerned it could accelerate and not subside. At the hospital, they took her in an exam room and did her vitals and she was there about 2-3 hours and it was early in the morning and at that point sometime they took a chest x-ray, EKG, and blood work and at that point prior to that while she was waiting she was feeling a little better, the worst had subsided and she suggested she go and they asked her to stay since she was already checked in and to be seen. The doctor looked at the results and read the film and questioned about emphysema and she felt that was unrealistic reading as she doesn't smoke, doesn't drink and it's not in her genetic make up. The doctor told her lungs were showing a lot of air and she said maybe it was because she was gasping and they told her to take a big gulp of a breath and hold it to get the X-ray. The doctor suggested she see a pulmonologist and she didn't feel that was warranted. She contacted her general practitioner and they recommended she get the 2nd shot and had her see an allergist who also suggested she get the 2nd shot. The patient stated that she was not really overweight and doesn't drink and doesn't smoke and the allergist didn't mention but she saw in the paperwork that a side effect could be difficulty breathing. She had no swelling, body rash, dizziness or weakness. Since that episode, she periodically throughout the day, and she can't tell if it's anxiety or allergies or something but she felt labored breathing and tightness in her chest and can't get a full intake of breath. She reported that when she sleeps on her back the sensation disappears completely and when she sleeps on her side it reappears a little; 1-2 nights after, it woke her from sleep and she doesn't think she was dreaming about anxiety. She stated that she has never had anaphylactic if this should escalate what to do and she decided to go to the ER and they had her wait an additional 2 hours for a follow-up reading that was all clear, all fine, except emphysema thing which was again, she was just researching and forgot the medical term, she this it was hype aeration, too much air sucked in. Her general practitioner recommended she see an allergist for a 2nd opinion and was surprised she was up on anything and didn't mention side effect and the handout said it could be a possible side effect. She has to yawn a lotto get the air in. She does have laryngopharyngeal reflux prior and she clears her throat which is probably annoying and controls that through diet instead of taking Pepcid AC. She has had to clear her throat a lot but never had labored breathing or shortness of breath, that to get a full breath sometimes she has to yawn to get past that tightness of shallow breathing or labored breathing. On certain days she doesn't feel it and thinks it was done and she will have a spate and it happens and she thought there was something stressing and does a reality check and again it's that time of year and when she was taking her walk and walked past a certain block she started to wheeze from the pollen on an unspecified date and she called her allergist to see about getting something. She had a mask and that helped a little. Her allergies were not exacerbating on 23Mar2021 or 26Mar2021 but started the last few days and she has a wheezing cough that had an extended sort of wheeze at the end of the cough. Before her cough for LPR it was annoying throat clearing. After the vaccine, she took that walk through that one specific spot on her route she got to coughing and thinking she needs to call and get something prescribed something if anything if she gets the second shot it will address any of the side issues if they were related to allergies so don't have to contend. It was every night where she sort of feels it and she sleeps through the night so if it was tension related it subsides and can't distinguish what is emotional and physical but she was sleeping through the night and it was an indication that it was improving. She reported that when she visited her son and after she returned he told her he was unaware he had strep and didn't know it, he was asymptomatic and she had a sore throat and went to urgent care and had an exam and didn't have strep and doesn't know what it was but she was feeling better by the weekend. She was supposed to go back and everything was shutting and she didn't go. Maybe she was exposed and just had a mild thing while she was there. She was tested for Covid on 26Mar2021 and her result was negative, but they did not do an antibody test. She wanted to know if difficulty breathing was a common reaction with the vaccine, and if the side effects would be lesser after the 2nd dose since she already had a severe reaction after the 1st dose and if she should still receive the 2nd dose of the vaccine. She was concerned the 2nd shot will be more pronounced than the 1st and she doesn't want to go through that and it be more severe. She has heard if you had that reaction you may have been exposed to Covid before and she may have been around people with Covid that had positives and she may have antibodies from an asymptomatic experience and it may do more harm than good and she should do the 2nd shot. She mentioned this to her allergist and was told if she has a similar symptoms to call and get a bronchodilator. She was onboard with that but wants to discuss it because she finds it hard to believe she was the only one that had difficulty breathing and was wondering what was the duration of this labored breathing. She was scheduled for the second dose 18Apr2021. Outcome of events sore throat was recovered on an unspecified date; and outcome of rest of events was unknown.
65 2021-04-27 malaise Patient with dementia NOS received COVID-19 vaccination first dose (as reported) on 3/30/2021. Famil... Read more
Patient with dementia NOS received COVID-19 vaccination first dose (as reported) on 3/30/2021. Family reported she was feeling unwell with vague complaints thereafter. Found dead on 4/27/2021. Autopsy performed on 4/28/2021 revealed ischemic bowel with an acute superior mesenteric artery thrombosis. She had little other cardiovascular disease to account for the thrombosis.
66 2021-01-02 headache, fatigue, chills, fever Headache, low fever 99.9-100, chills, fatigue started 1/3/2021
66 2021-01-04 sweating 66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg ... Read more
66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg po, diphenhydramine 50mg PO at 1000. She also was administered NaCL 0.9% as a carrier for durvalumab as an infusion between 1000-1200. Pt was administered COVID19 vaccine at 1110. At 1120 patient called out stating "I just don't feel right". Pt was diaphoretic/weak/hypotensive. No swelling or respiratory distress noted during the episode. Attending physician and PharmD alerted and were at bedside. Per note, pt has needle phobia. Please refer to relevant history below for information regarding BP. Patient was monitored closely at the infusion clinic. She was able to receive her chemo agent as planned after she felt better from eating. Patient does not wish to get the second dose of covid vaccine.
66 2021-01-04 headache, fatigue Headache, Extreme Fatigue; Headache, Extreme Fatigue; This is a spontaneous report from a contactabl... Read more
Headache, Extreme Fatigue; Headache, Extreme Fatigue; This is a spontaneous report from a contactable Other-HCP. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number Unknown), intramuscular at Left arm on 23Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included Diabetes mellitus, Known allergies: penicillin. Concomitant medication included metformin. The patient experienced headache, extreme fatigue on 23Dec2020 23:00. Both events were non serious. No treatment was received. The patient was not Pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the events was resolved in Dec2020. Information about lot/batch number has been requested.
66 2021-01-04 headache Patient was experiencing headache, lightheadedness, generalized itching, shortness of breath, wheezi... Read more
Patient was experiencing headache, lightheadedness, generalized itching, shortness of breath, wheezing, and nausea after 8-10 minutes of COVID-19 vaccine administration. Vital signs were stable RR 22 and SpO2 96% on RA. She was speaking in full sentence, no acute distress, with expiratory wheezing. No central cyanosis or new rash. After 15 minutes, she reports improvement on her symptoms. She was given Benadryl po and Albuterol 2 puffs in the clinic with improvement on her symptoms. Lungs have more air movement and less wheezing after the albuterol treatment. She was send home and educated in ED precautions.
66 2021-01-04 chills, fatigue Starting the day after vaccine I have had extreme fatigue, nausea, decreased appetite. dizziness, mu... Read more
Starting the day after vaccine I have had extreme fatigue, nausea, decreased appetite. dizziness, muscle aches, chills. It has continued now for 14 days, without improvement. It is actually worsening.
66 2021-01-04 headache difficulty communicating, difficulty thinking; difficulty communicating, difficulty thinking; diffic... Read more
difficulty communicating, difficulty thinking; difficulty communicating, difficulty thinking; difficulty communicating, difficulty thinking/She could not talk; her tongue was acting like it was swollen; Headache; Dizziness/she got really dizzy; This is a spontaneous report from a contactable consumer (patient). A 66 years old years female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1685, Expiry Date: Mar2021) via intramuscular at right arm on 22Dec2020 16:00 at single dose for preventative (COVID-19 immunization). The patient's medical history was allergic to iodine, yellow jackets, and perfumes or colognes. The concomitant was reported as none. The patient clarified that after receiving the vaccine she started with headache and then she got really dizzy. The dizziness lasted for about a day. Headache lasted for about 2 or 3 days. She had difficulty communicating with people or thinking. She could not talk, her tongue was not swollen but her tongue was acting like it was swollen. Events onset date was in Dec2020. She experiences these symptoms when she has any reaction to her allergies. Treatment included that She has been taking what she always takes for her allergies which is Tylenol for headache and Benadryl for her allergies. Her second dose was scheduled for 12Jan2021. She was asked to go to the hospital but she did not have time to go to the hospital. States she works three jobs and did not have the time. The outcome of the events was recovered completely from all side effects on Christmas day (on 25Dec2020).
66 2021-01-04 chills stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable other healthcare p... Read more
stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable other healthcare professional. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at left arm on 24Dec2020 08:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in a hospital facility. Medical history included hypertension, and allergic to penicillin. The patient was not diagnosed with Covid-19 prior vaccination. Concomitant medication included amlodipine and irbesartan; both from unspecified date for unspecified indication. On 26Dec2020 22:30, the patient experienced stomach cramps, diarrhea and chills. The patient was not tested for COVID-19 post vaccination. The patient did not receive treatment due to the events. The outcome of the events stomach cramps, diarrhea and chills was recovering. The reporter considered the events non-serious; the events did not results in death, not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
66 2021-01-05 headache Severe headache and nausea
66 2021-01-05 fatigue, headache, chills, throat pain Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward aro... Read more
Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward around shoulder blade, severe headaches, nausea (no vomiting), sore throat, FATIGUE, chills/cold sweat, general body aches.
66 2021-01-05 fatigue, dehydration, chills, headache severe chills, dry stinging mouth, headache, dehydration, dry heaves,nausea, for approximately 6 hrs... Read more
severe chills, dry stinging mouth, headache, dehydration, dry heaves,nausea, for approximately 6 hrs. The symptoms resolved then she experienced Headache, fatigue body aches until 01/06/2021 @0600.
66 2021-01-06 fever, headache Awoke in the middle of the night with spiking fever 101.5, headache, muscle aches, diarhea, In bed f... Read more
Awoke in the middle of the night with spiking fever 101.5, headache, muscle aches, diarhea, In bed from Monday night to Wednesday morning started feeling better.
66 2021-01-06 chills, headache Headache, nausea, really bad chills that woke her out of her sleep
66 2021-01-06 cough, fever, chills The patient states on 12/18/2020 at approximately 1430 a rash on both arms appeared. The rash has l... Read more
The patient states on 12/18/2020 at approximately 1430 a rash on both arms appeared. The rash has lasted several weeks. The rash continues to be present on 01/06/2020. No itchiness. Patient also states on 12/18/2020 at approximately 1700, she started with chills which got progressively worse throughout the evening, fever (99.8 F), patient states this temperature is 'high' for her, body aches, shortness of breath and a cough. All these symptoms got worse enough where she thought she had to call 911. However, the symptoms eventually subsided that night and she did not need to call 911. The body aches, chills and "fever" lasted for about 2 days.
66 2021-01-09 influenza like illness, headache Headache and flu like symptoms lasting 20 hours
66 2021-01-10 malaise, chills, influenza like illness 1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 9... Read more
1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 99.3, muscle pain arms and legs worse Uncomfortable during the entire night (tossing and turning) 1/10/21- 07:30-General malaise(flu like symptoms)- muscle pain-feeling weak T-99 started feeling better during the late afternoon, still with muscle pain , T-98.7
66 2021-01-10 headache Headache occurred at 18 hr after dose Ibuprofen 400mg po every 8 hours Duration is 48 hr
66 2021-01-10 fever Low grade fever which lasted 24 hours. Raised, reddened area at site of injection also as well as si... Read more
Low grade fever which lasted 24 hours. Raised, reddened area at site of injection also as well as significant left axillary lymph node enlargement which both persist.
66 2021-01-10 headache, body temperature increased Patient had vaccine in Left arm. That same night patient had temp of 100.1 and the right neck at ba... Read more
Patient had vaccine in Left arm. That same night patient had temp of 100.1 and the right neck at base of head to shoulder began to hurt patient was unable to swallow without pain in the next few days. Patient went to ER and was hospitalized for 2 days treated with IV steroids and 2 antibiotics (clindamycin and acyclovir). Patients symptoms resolved and patient was discharged without additional issues. The admitting physician was unable to identify the cause of these symptoms, but the vaccine could not be ruled out.
66 2021-01-11 fatigue, sweating "45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,... Read more
"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,muscle aches , pain some Syncope, nausea, sweating on and off, oral herpes outbreak just like I did when I had Covid -19 in April"
66 2021-01-11 headache, fever, chills 9 hours after receiving the vaccine I experienced joint pain, muscle pain, headache, fever and chill... Read more
9 hours after receiving the vaccine I experienced joint pain, muscle pain, headache, fever and chills. Symptoms resolved after 36 hours.
66 2021-01-11 chills, fever I felt close to passing out as my first symptom after receiving the booster. Since I had not heard... Read more
I felt close to passing out as my first symptom after receiving the booster. Since I had not heard this as a reaction, I thought I should report it. I felt faint numerous times up to 90 hours afterward. Then complete resolution. I also had 101 fever for 24 hours, chills, body aches, but these symptoms have been listed as common.
66 2021-01-11 chills, fever, headache Injection site pain, chills, fever, headache, muscle pain, nausea 12 hours after second vaccine
66 2021-01-11 headache c/o headache shortly after receiving Covid vaccine b/p 158/87 HR 81 Pulse ox 98% monitored ee, state... Read more
c/o headache shortly after receiving Covid vaccine b/p 158/87 HR 81 Pulse ox 98% monitored ee, states feeling better nor headache upon leaving clinic. b/p121/74, HR 78 02 sat 98%
66 2021-01-11 fever, chills, headache onset of severe headache, chills, nausea, fever to 101.5 and chest tightness (pulse ox dropped to 92... Read more
onset of severe headache, chills, nausea, fever to 101.5 and chest tightness (pulse ox dropped to 92% requiring treatment with albuterol several times during the day. Inset of symptoms occurred approximately 16 hours after vaccination. Fever and other symptoms began subsiding approximately 24-28 hours after vaccination.
66 2021-01-12 headache Headache, generalized body aches/pain, pain in legs for 18 hours
66 2021-01-12 headache, fatigue Headache,Fatigue, Body aches,
66 2021-01-12 headache, fatigue Sudden onset of severe headache, dizziness, joint pain, exhaustion at 9:00pm
66 2021-01-12 fever, chills fever T104.2, HR115, shivering, nausea, throat feels dry, vomiting Taking Tylenol Prescribed Zofran ... Read more
fever T104.2, HR115, shivering, nausea, throat feels dry, vomiting Taking Tylenol Prescribed Zofran by PMD Prescribed Ibuprofen by ED MD
66 2021-01-13 body temperature increased, headache, chills 6:30 am 1/13/21: swelling in right axilla, headache, body aches, soreness at injection site 4:pm 1/1... Read more
6:30 am 1/13/21: swelling in right axilla, headache, body aches, soreness at injection site 4:pm 1/13/21: temp 99.8, chills, selling and redness in right axilla extending to right breast, body aches, severe headache 6:30 am 1/14/21: afebrile, moderate body aches and headache, increased swelling and redness in right axilla extending to right breast Called PCP office. Told to continue Tylenol and use ice packs
66 2021-01-13 influenza like illness Aching in arms & legs; After 2nd vaccine felt like I had the flu; This is a spontaneous report from ... Read more
Aching in arms & legs; After 2nd vaccine felt like I had the flu; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 15Dec2020 15:00 (lot EH9899, expiry date not reported) in the left arm, then second dose on 05Jan2021 (lot EL0142, expiry date not reported); both via an unspecified route of administration at a single dose as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had other medications (unspecified) in the two weeks prior to vaccination. The patient was not pregnant at the time of vaccination. On 06Jan2021 02:00, the patient experienced aching in arms and legs, and reported that after 2nd vaccine felt like patient had the flu. The patient did not receive any treatments for the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient recovered from the events aching in arms and legs and felt like patient had the flu in Jan2021.
66 2021-01-13 chills, fever Day following: severe body aches, chills and fever and slight nausea. The second day following inje... Read more
Day following: severe body aches, chills and fever and slight nausea. The second day following injection felt a bit better but that evening night sweats and third day following quite nauseated.
66 2021-01-13 sweating Dizziness Narrative: employee said her heart was low, so she laid on the floor C/o sweaty, diziness,... Read more
Dizziness Narrative: employee said her heart was low, so she laid on the floor C/o sweaty, diziness, lying on floor felt better. PMH of vascular response, taking beta blocker had juice felt better. Vss. 115/76 bp pulse 65. Recheck b/p 103/69 65 pulse, 101/68 pulse 69 oxygen sats room aire were 100. initial pulse was 43 b/p 115/76. Resolved after rest elevated legs, and fluids. Employee left about after and hour walking well, with no further c/o symptoms all seemed to resolved She was instructed to go the emergency room any further symptoms. She verbalized back the plan.
66 2021-01-13 headache, fatigue, body temperature increased Note: Took Tylenol 1000 mg before injection and every 4-6 hrs since injection 1/11/21 9:00 pm, sor... Read more
Note: Took Tylenol 1000 mg before injection and every 4-6 hrs since injection 1/11/21 9:00 pm, soreness at injection site 1/12/21 6:30 am, soreness at injection site, slight swelling in right axilla 1/13/21:6:30 am, soreness at injection site, moderate swelling in right axilla, headache, body aches 1/13/21 4:00 pm, temp 99.8, soreness at injection site, increased swelling and redness in right axilla extending to right breast, severe headache. body aches, fatigue 1/14/21 6:30 am, afebrile, increased swelling and redness right axilla extending to right breast, headache, body aches. 1/14/21 10:00 am, Called PCP office. Told to take Tylenol and use ice at axilla, and report to CDC
66 2021-01-13 headache, chills chills, shaking, headache, neck ache, joint pain, nausea, vomiting
66 2021-01-13 fatigue extreme tiredness/reported as worsened; This is a spontaneous report from a contactable consumer (pa... Read more
extreme tiredness/reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK9231), intramuscular on the left arm on 06Jan2021 14:50 at SINGLE DOSE for COVID-19 immunization (also reported as preventative) at the hospital. Medical history was not reported. There were no concomitant medications. It was reported that the patient had tetanus shot around 21Dec2020 or 22Dec2020. The patient also had prior vaccinations which included first pneumonia shot was fine. During the second pneumonia shot, the patient had extreme swelling on left arm and could not lift her arm. She was off work several days due to the pain. It was part of a two shot series for those over 65 years old. She had the COVID-19 vaccine yesterday (06Jan2021). The patient had extreme tiredness that started a that night of 06Jan2021 and was really ongoing at the time of the report. She does not want to fall asleep while driving home as she was at work. She has an appointment for the second dose on an unknown date. It was mentioned that the extreme tiredness was reported as worsened (not recovered).
66 2021-01-14 chills, fever, fatigue Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle ... Read more
Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle pain 8/10; other vaccine same date vaccine date 05Jan2021; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included DM type 2, hypertension (HTN), fibromyalgia, chronic asthma, Covid prior vaccination, No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date included other vaccine same date product was Pfizer, other vaccine same date vaccine date 05Jan2021. On 06Jan2021, the patient experienced Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. No treatment received for the adverse events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. The events were non-serious per the reporter. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus was recovering. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bone and muscle pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-01-14 fatigue Fatigue, body aches 1/12-13/21 and extreme nausea on 1/14/21.
66 2021-01-14 fatigue Fatigue, nausea, vomiting, fever, chills, headache, muscle aches. (All began immediately following 2... Read more
Fatigue, nausea, vomiting, fever, chills, headache, muscle aches. (All began immediately following 2nd dose and have continued to present day. However, as of 1/15/21 symptoms have begun to subside.)
66 2021-01-14 fatigue, lethargy, influenza like illness Flu-like symptoms; lethargy; athralgias; fatigue; This is a spontaneous report received from a conta... Read more
Flu-like symptoms; lethargy; athralgias; fatigue; This is a spontaneous report received from a contactable consumer. A 66-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in left arm, on 07Jan2021 08:00, at single dose, for COVID-19 immunization, in the hospital. Medical history included Meniere's disease and penicillin allergy. The patient was not pregnant at the time of vaccination. The patient had no other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in left arm, on 17Dec2020, for COVID-19 immunization. The patient experienced flu-like symptoms, lethargy, athralgias and fatigue on 08Jan2021 at 21:45. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
66 2021-01-14 body temperature increased Patient had an elevated temperature that reached a max of 101.2 before resolving.
66 2021-01-14 sweating Periods of tachycardia and diaphoresis started 7 hours after vaccine Had 3 "spells" of it ending am... Read more
Periods of tachycardia and diaphoresis started 7 hours after vaccine Had 3 "spells" of it ending am of 1/14/21
66 2021-01-14 headache, headache Sore arm, headache
66 2021-01-14 fatigue Sore arm, loss of appetite, fatigue, extreme dizziness, drop in blood pressure
66 2021-01-15 malaise, headache about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomac... Read more
about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomach and intestine cramps and 3 days later i still have them. also still have lots of nausea. body aches all over. swelling ankles more on right side, headache, fell sick all over. no treatment just staying in bed.
66 2021-01-18 malaise, chills Chills; Malaise; Hives; Other vaccine same date details: [{other vaccine same date product= Pfizer/B... Read more
Chills; Malaise; Hives; Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]; Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]; This is a spontaneous report from a contactable other hcp. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, intramuscular on 08Jan2021 11:30 at a SINGLE DOSE and via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunisation. Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]. Medical history included drug hypersensitivity to Penicillin from an unknown date and unknown if ongoing. Concomitant medication included lisinopril (LISINOPRIL) and atorvastatin (ATORVASTATIN). The patient previously took clindamycin and experienced drug hypersensitivity. The patient experienced Hives, Chills, Malaise on 08Jan2021 18:00. The outcome of the event was unknown. Information on the lot/batch number has been requested.
66 2021-01-18 fever Fever
66 2021-01-18 fatigue, fever, headache, chills Fever 101-102. Chills (wearing winter coat and several winter blankets to get warm), headache, feeli... Read more
Fever 101-102. Chills (wearing winter coat and several winter blankets to get warm), headache, feeling of eyes popping out of head, muscle aches all over, and exhaustion. Feel like I have covid all over again.
66 2021-01-18 headache Within minutes of receiving my first dose injection, my mouth and tongue began to itch and my tongue... Read more
Within minutes of receiving my first dose injection, my mouth and tongue began to itch and my tongue began to swell. I also had a headache and felt nauseous. Over time, I also had some difficulty breathing
66 2021-01-19 chills, fever Fever 99.4, chills, aches
66 2021-01-19 headache, chills, fever Headache, fever, chills, body aches.
66 2021-01-19 fatigue Patient felt "tired" getting up from chair. Patient was seated and evaluated. Patient has past medic... Read more
Patient felt "tired" getting up from chair. Patient was seated and evaluated. Patient has past medical history of DM and did not take metformin today, and did not eat anything today. Was anxious about getting vaccine. Felt better after sitting and able to get up without problems. Felt well enough to return home.
66 2021-01-19 fatigue Patient felt "tired' getting up from chair. Patient was seated and evaluated. Past medical history o... Read more
Patient felt "tired' getting up from chair. Patient was seated and evaluated. Past medical history of DM on metformin - did not take metformin today, and did not eat anything. Anxious about getting vaccine. Patient felt better after sitting, and able to get up without problems. Felt well enough to return hoe.
66 2021-01-20 cough Cough began 12/27/20 followed by severe migraine on 12/31/20.
66 2021-01-20 malaise I am an RN at this hospital, I received second injection 1/13/2021. On 1/15/2020 felt sick enough to... Read more
I am an RN at this hospital, I received second injection 1/13/2021. On 1/15/2020 felt sick enough to just lay down all day, then left arm below injection site became moderately swollen, itchy and inflamed. This has lasted until today 1/20/2021 swelling, inflammation and itching has subsided 50 %. It was most of my upper arm an extensive area.
66 2021-01-20 fever, headache, chills Injection site pain; chills; fever; headache; muscle pain; nausea; This is a spontaneous report from... Read more
Injection site pain; chills; fever; headache; muscle pain; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old female patient received the second dose of BNT162B2 (Pfizer, lot number: EL3246), intramuscularly in left arm on 08Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included known allergies: sulfa drugs. Concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (lot number: EK5730), intramuscularly in left arm on 21Dec2020 17:00 for COVID-19 immunization. Patient experienced injection site pain, chills, fever, headache, muscle pain, and nausea 12 hours after second vaccine on 08Jan2021 22:00. No treatment was received. Patient was recovered from these events. No follow-up attempts are possible; no information is expected.
66 2021-01-20 fatigue, cough Patient presented with worsening fatigue and shortness of air that began Friday(1/15/21) after recei... Read more
Patient presented with worsening fatigue and shortness of air that began Friday(1/15/21) after receiving COVID 19 vaccination. She has also had nausea, vomiting, and diffuse abdominal pain since that time. Patient has had a cough for last five days. Patient admitted to ICU for care on 1/17/2021.
66 2021-01-21 fever, chills, headache HAD FEVER, HEADACHE, BODY ACHES, AND CHILLS
66 2021-01-21 fatigue Severe weakness Extreme fatigue Loss of appetite
66 2021-01-22 fever, chills, headache Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm p... Read more
Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm pain, generalized muscle aches. 36 hours after developed chills, fever 102.5, headache, fatigue 48 hours fatigue, muscle aches present but less fatigue lasted 5 days
66 2021-01-22 nasopharyngitis, fatigue Tiredness, cold and muscle aches
66 2021-01-24 headache ?Pfizer-BioNTech COVID-19 Vaccine EUA blurry vision next day and headache, but had slightly abnormal... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA blurry vision next day and headache, but had slightly abnormal eye exam by eye doctor so could be primary ophthalmologic issue. also seen by neurology and normal CT scan of head
66 2021-01-24 headache At 1132, Pfizer was administered. RRT called at 1138 in the post-vaccine Recovery area for a 66 y/o ... Read more
At 1132, Pfizer was administered. RRT called at 1138 in the post-vaccine Recovery area for a 66 y/o female that complains of upper chest tightness and temporal tightness, pain 3/10, non-radiating. 4 RNs responded to the scene. Head-to-toe assessment completed. She reports allergies to sulfa. She took multiple morning medications today, all regularly taken. Hx of stents, HTN, HLD, DM, WPW, irregular HR. Initial vitals: HR: 125, BP: 126/80, RR: 19, O2 98% on RA. Denies nausea and SOB. At 1148, she reported that her pain was subsiding. Given medical hx, RRT activated 911 response, called by Site Manager. At this point, client calm, AA0x4, skin WNL, resp WNL. 1201 EMS arrived and report was given to them. Client taken into ambulance for EKG. ALS response provided. Nitro and ASA given. EKG revealed A-fib, HR 120, O2 96%. Client to be taken to Hospital via ambulance, truck number 490. EMS assumed care at 1214. Husband that was with client was told of plan.
66 2021-01-24 headache Vaccinated 1/20 at her PCP. Pt was seen by NP via telemedicine urgent care complaining of severe per... Read more
Vaccinated 1/20 at her PCP. Pt was seen by NP via telemedicine urgent care complaining of severe persistent headache and all-over body pain since 1/23, reportedly in too much pain to even move out of bed all day on day 4 after COVID vaccination (1/24). Still in pain today, primarily in arms and shoulders, but is able to ambulate and conduct ADLs. Headache persists with some dizziness. Encouraged to rest, hydrate, and take Tylenol PRN. Strict ED precautions for any CP, SOB, syncope, or evidence of allergic reaction.
66 2021-01-25 headache, fever, chills Fever, body ache, HA, nausea, chills, tremors, O2 sat = 96%
66 2021-01-25 fatigue, sleepiness I am quite really tired/I have never been this tired during the day time like I am right now; I fell... Read more
I am quite really tired/I have never been this tired during the day time like I am right now; I fell asleep sitting in the chair/I feel like I took something that helped me to sleep; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Batch/lot number: EJ1686), via an unspecified route of administration at deltoid left on 12Jan2021 at single dose for covid-19 immunization. Medical history included hypertension, diabetes, High cholesterol, asthma, Allergies, irritable bowel syndrome, depression. Concomitant medication included lisinopril, metoprolol, hydrochlorothiazide (HCTZ), glipizide, sitagliptin phosphate (JANUVIA), budesonide, formoterol fumarate (SYMBICORT Inhaler), montelukast sodium (SINGULAIR), montelukast, levocetirizine for allergies, levocetirizine dihydrochloride (XYZAL) for allergies, atorvastatin, dicycloverine (DICYCLOMINE), sertraline as anti-depressant, ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient was quite really tired, she was trying to get walked on, so, she can work because she worked from home and she was sitting here, and she fell asleep sitting in the chair in front of computer. She tried to reach employee health at work, but they were helping in the shot clinic. She had never been this tired during the daytime like she was right now, she felt like she took something that helped her to sleep on 12Jan2021. The nurse did not visit any emergency room/ physician office. The patient had drunk coffee and was drinking diet coke for caffeine. No other treatment received for the events. The outcome of the events was unknown.
66 2021-01-25 cough, throat irritation Patient with known allergies in observation area following injection noted flushed cheeks, chest tig... Read more
Patient with known allergies in observation area following injection noted flushed cheeks, chest tightness, and reported to clinical manager.(10:16) Given 25mg PO Benadryl and continued observation. AT 10:30, no resolution of symptoms-telehealth visit initiated. Vital signs stable, Oxygen sat at 97%, patient with c/o cough and scratchy throat. Order given and medication administered. Solumedrol 125mg IM. Additional 1 hour observation-symptoms resolved, and patient was discharged to home.
66 2021-01-25 chills Shot site on arm began hurting a lot around 1am the next day Jan 26. I began to feel nauseous the ne... Read more
Shot site on arm began hurting a lot around 1am the next day Jan 26. I began to feel nauseous the next day at 11 am. Also had some chills. Took Advil soon after and helped alleviate the chills right away. Received Pfizer-BioNTech COVID-19 Vaccine EUA
66 2021-01-25 sleepiness, headache arm soreness; very achy; Drowsiness; bad headache; This is a spontaneous report from a contactable c... Read more
arm soreness; very achy; Drowsiness; bad headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 11Jan2021 at single dose (1.8 cc but unsure ((heard that but could be wrong) recommended dose)) as works with COVID positive patients. Medical history was none. No concomitant medications. Caller just wanted to know if she could take Tylenol for mild symptoms after having the COVID 19 vaccine. She received the vaccine yesterday. She was wondering if it would make the symptoms a little less. She didn't have a prescribing doctor. The side effects started last night. On 11Jan2021, she was expecting arm soreness, but this was worse. She developed it about 6 hours after the shot. This was the sorest her arm has ever been from any injection, and she had had a lot of them. Her arm was almost too sore to move. This morning, it was much better. It was really bad last night. She was also very achy, and experienced drowsiness, also has a very bad headache on 11Jan2021. The CDC website stated before the vaccine patients should not take Tylenol because it can tamper with the immune system response. It said it was alright to take after, but she just wanted to call to make sure. Investigation Assessment was no. The outcome of the event very achy was not recovered, of the events was recovering.
66 2021-01-25 headache, chills, fever chills fever body aches nausea diarrhea headache
66 2021-01-26 chills, fatigue, headache Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A hea... Read more
Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A headache; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EH9899, expiry date: unknown), via an unspecified route of administration on 06Jan2021 10:30 at single dose (Right upper arm) for COVID-19 immunization. Medical history included Blood pressure (takes blood pressure medication). The patient's concomitant medications included blood pressure medication. The patient experienced a sore arm, chills, tremor in fingers and a headache when she came home from being vaccinated. The morning after, she experienced dizziness, tiredness and passed out. She then checked her blood pressure and it was fine and then she went to bed and slept all day. She got up around 7 pm and was fine. It was further reports that the patient received first COVID Vaccine on 06Jan2021. She came home and was fine. Arm was a little sore. During night had chills and noticed fingers had tremors. Had a bad headache. Woke up in morning and went to do usual things. Was dizzy and passed out. Woke up on floor. Husband helped her back into bed and she slept the whole day. After that she was absolutely fine. They were curious, but a little bit concerned about taking the second dose. Advised patient to follow up with primary care physician. She went to primary care physician yesterday. Primary care physician advised her to take the second dose of COVID Vaccine stating he didn't see why she couldn't take it. HCP Details: Address and email address are unknown Received first dose of COVID Vaccine on 06Jan2021 around 10:30. Chills: began at 23:00 Fingers had tremors: began 23:00 Bad headache: did not provide time of onset Dizzy and passed out: 08:00 Woke up absolutely fine on 07Jan2021 around 19:00 Indication: 66 years old and it was available to her Causality: Yes, because she was fine before then History and Investigations: Takes blood pressure medication, but blood pressure has been normal. Product name not provided by caller. Vaccination facility type was at a skilled nursing facility. The outcome of the events was unknown. Chills, Tremor in fingers, headache, Dizziness, and Passed out were reported as Medically significant events. Reaction assessed for Chills, Fingers had tremors, Had a bad headache, Dizzy, and Passed out. Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including chills, tremor in fingers, headache, dizziness, and passed out, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
66 2021-01-26 fever, fatigue diarrhea, can't eat, 99 fever, dizzy, abdominal pain, muscle pain,fatigue
66 2021-01-26 headache joint pains; headaches; This is a spontaneous report from a contactable other health professional. A... Read more
joint pains; headaches; This is a spontaneous report from a contactable other health professional. A 66-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3246), intramuscularly on 11Jan2021 at 10:00 at a single dose for COVID-19 immunization. Medical history included pre-diabetic from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing; known allergies: no. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose-lot number: EJ1685, intramuscularly, in the left arm at 19:30) for COVID-19 immunization on 22Dec2020. Concomitant medications included calcium (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), simvastatin (ZOCOR); all taken for an unspecified indication from an unspecified date to an unspecified date. On 12Jan2021 at 03:00, the patient experienced: joint pains and headaches; no treatment was reached. The clinical outcome of the events was recovered in Jan2021. There were no other vaccines within four weeks of the suspected vaccine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
66 2021-01-28 headache, cough 24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-remi... Read more
24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-reminded if She gets worse-GO the ER-or have someone drive her there-for instance-SOB 25th Jan 2021-Monday-legs, to mid calves-swollen 26th Jan Tuesday-still coughing a lot 27th Jan like the 24th of Jan 2021-hurts to breathe, HA, body slows, hoarse when speaking, Cough a lot. 28th Jan 2021-Thursday-her Back hurt. Her waist & shoulder blades painful 29th Jan 2021-today-she said COVID-19 reaction-that's why she called
66 2021-01-28 chills, headache, fever CHILLS FEVERISH BODY ACHES JOINT PAIN HEADACHE
66 2021-01-28 fatigue Dizziness, muscle pain, tiredness, joint pain I woke up to use the bathroom. after relieving myself... Read more
Dizziness, muscle pain, tiredness, joint pain I woke up to use the bathroom. after relieving myself I stood up and got very dizzy, then I fell down. I fell again after I got myself up.
66 2021-01-28 headache, fever Fever, aches, headache, swollen glands, and joint pain.
66 2021-01-28 lethargy Joint and muscle pain/ lethargy
66 2021-01-29 chills 24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild chills. While... Read more
24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild chills. While trying to get blankets, turning up heat, preparing dinner, had abnormal muscle and joint pain upon any movement. No muscle or joint pain while sitting still.. 6 hours after symptoms took acetaminophen 500mg and diphenhydramine 25mg . 9 hrs after onset of symptoms felt fine with no symptoms and slept through the night fine. 48 hrs after vaccine feel completely normal.
66 2021-01-29 fatigue Extreme fatigue, unable to stand or walk, dizziness, physical weakness, upset stomach,
66 2021-01-29 malaise, headache, fatigue, throat irritation Pfizer-BioNTech COVID-19 Vaccine EUA Side Effects: Injection site pain, tiredness, headaches, join... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Side Effects: Injection site pain, tiredness, headaches, joint pain, feeling unwell, swollen lymph nodes, rough-feeling throat lasting just over 24 hours
66 2021-01-31 fatigue Feeling achy, tired and not myself
66 2021-01-31 fever Fever of 102, treated with 2 tablets regular strength Tylenol. Checked temp. 4 hrs. later and rec... Read more
Fever of 102, treated with 2 tablets regular strength Tylenol. Checked temp. 4 hrs. later and recorded 98.8. Fever never returned and I have remained fever free.
66 2021-01-31 pneumonia, headache I got a headache and I have had one ever since receiving the vaccine (and I'm not prone to headaches... Read more
I got a headache and I have had one ever since receiving the vaccine (and I'm not prone to headaches) - they come and go. I never have had these before. I had wheezing and it was getting worse- on the 30th and I went to Urgent Care 31st. Was a diagnosed with Pneumonia. Doxycline - was prescribed. I'm still wheezing but I feel fine. But I'm not wheezing as heavy as it was. I received second dose of January 14 - no other symptoms.
66 2021-01-31 throat irritation Tingling in lips, heaviness in chest, scratchy tongue and throat.
66 2021-01-31 throat irritation itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an ... Read more
itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; arm soreness; dry throat; arm discomfort; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 17Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included Cholesterol and Blood pressure, patient stated she took low dose medication for her blood cholesterol and blood pressure, but has had no new medications. She had a history of some allergies: a slight shrimp and scallops allergy, possible peanuts, penicillin, and a Neomycin product. She said they were not a big deal, and she had environmental allergies as well. She had an allergic reaction to the eye drop Neomycin, possibly, just the eye drop, she had a little breakout around her lips but she didn't know if it was the drug or not. The allergy to shrimp and scallops showed up in a blood test, her reaction to peanuts around her mouth but she had a negative scratch test and blood test for allergy to peanuts. The patient's concomitant medications were not reported. The patient stated she did get the flu vaccine, that was ok, she was fine, this was probably around Nov2020 or so, though she didn't know off hand when she got it, it was the regular flu vaccine and not an increased dose. The patient experienced arm discomfort on 17Jan2021, itching to eyes, mouth, and throat an hour after vaccination on 17Jan2021 12:00. The patient took the first shot yesterday (17Jan2021) and she had some discomfort to her arm, but it didn't bother her. She got the shot about 11:00 yesterday (17Jan2021) and about an hour after the shot she had some itching to her eyes, mouth, and throat that was not severe then was on and off through the day. She would like to know if this is common, she would like the information for the second dose, if she should expect more or less or same, she was concerned about the second dose. She did not have a severe reaction, she just wanted to make sure there weren't any adverse reaction for that make sure she known. She had not seen a doctor for her itching eyes, mouth, and throat. She didn't do any treatment for it, it was better today (18Jan2021), she just noticed it an hour after the injection that she felt a bit of eyes being itchy and all over, her mouth and throat were not severe, but she definitely felt it through the day. She felt it a little at night sometimes anyway like a dry throat. It was gone this morning and her arm was better, it seemed like the itching went with the arm things since following her arm soreness her itchiness started, then when her arm felt better the itchy was going away. The outcome of events was recovering. Information on the Lot/Batch number has been requested.
66 2021-01-31 headache severe upper stomach pains and stomach pains all over and cramps; all over body pain; headache; naus... Read more
severe upper stomach pains and stomach pains all over and cramps; all over body pain; headache; nausea; ankles swelling more the right one; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the right arm on 13Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included Coronary artery disease (CAD), 2nd degree AV heart block, acid reflux, gastritis, high blood presure, fibromyalgia, gammaglobulinemia, allergies to sulfa, eggs, milk, fish, shrimp, and nuts. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan (DIOVAN), esomeprazole sodium (NEXIUM), acetylsalicylic acid (BABY ASPIRIN), alprazolam, atorvastatin (LIPITOR). The patient previously took codeine, morphine, clopidogrel (PLAVIX), isosorbide mononitrate (IMDUR) and experienced allergies. On 13Jan2021 15:00, approximately 1 hour after the shot, the patient experienced severe upper stomach pains and stomach pains all over and cramps. A few hours later, she got all over body pain, headache, nausea, and her ankles were swelling more the right one. These events are all still going on 3 days later. Treatment was not provided in response to the events. The patient has not undergone COVID testing post vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
66 2021-02-01 headache, sweating, fever Received 2nd dose of Pfizer on 1/26/21 (Tuesday). Felt fine on 1/27(Wednesday, scheduled day off). ... Read more
Received 2nd dose of Pfizer on 1/26/21 (Tuesday). Felt fine on 1/27(Wednesday, scheduled day off). Woke up 1/28 (Thursday) around 3:00 am drenched. Had fever/chills and headache all day. Again on 1/29 (Friday) woke up drenched - had slight fever, but no headache. Called PCP on Thursday - told to rest, hydrate and eat BRAT diet. Called Thursday & Friday was told the same. By Saturday, felt almost myself again.
66 2021-02-01 fatigue, fever, chills flu; fever; chills; body ache; fatigue; This is a spontaneous report from a contactable healthcare p... Read more
flu; fever; chills; body ache; fatigue; This is a spontaneous report from a contactable healthcare professional. A 66-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) on her left arm, via an unspecified route of administration on 15Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included Allergies, Asthma, Sleep Apnea, Obesity, IBS, Depression and Arthritis. Concomitant medication included paroxetine hydrochloride (PAXIL), buspirone, unspecified allergy shots. The patient experienced Flu, Fever, Chills, Body Aches, Fatigue; all on 16Jan2021 09:45. No treatment was received for the events. The outcome of the events was recovered on an unspecified date in Jan2021.
66 2021-02-01 respiratory tract congestion, sneezing pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched ne... Read more
pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched nerve in my neck and blood pressure went up to 182/98; arm where she got the shot hurt like it was very tender; left breat hurt/then right breast hurt; having a little bit of trouble with asthma; congested and sneezing; congested and sneezing; bumpy rash on her chest and arms; puffiness/swelling in the neck; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration on 14Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing asthma and high blood pressure unknown if ongoing; both from unknown dates. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for asthma, unspecified vitamins and an inhaler for asthma. On 14Jan2021, the patient received the vaccination. She had a reaction to the vaccine almost immediately within 15 minutes of receiving vaccine. First, she had a pinched nerve in her neck and blood pressure went up to 182/98. Then about an hour later, the arm where she got the shot hurt like it was very tender. Then, her left breast hurt, followed by her right breast hurt. A few days later on 17Jan2021, she had breast pain and also pain under her arm. In Jan2021, she was also have some trouble with her asthma, was congested and sneezing. She had bumpy rash on her chest and arms. It was like tiny little bumps but it was not painful. She also had puffiness/swelling in the neck. The clinical outcomes of the pinched nerve in her neck, blood pressure went up to 182/98, arm where she got the shot was tender, breast pain, pain under arm, trouble with her asthma, congested and sneezing, bumpy rash, and puffiness/swelling in the neck were unknown.
66 2021-02-01 fatigue soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going... Read more
soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going to take my late night showers I looked at it and it had blister on it; blister; didn't sleep well/Didn't sleep well; sore arm; Around the skin it is discolored; This is a spontaneous report from a contactable consumer A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 08:15 at a single dose for COVID-19 immunization. Medical history included covid-19 around 15Jun or 16Jun2020 and did the quarantine. The patient's concomitant medications were not reported. Patient had soreness and tiredness the next day after vaccination on 16Jan2021 and took TYLENOL every 4 hours. She was concerned because on 16Jan2021, when she was going to take shower, it looked bruised, and blister on it. Patient didn't know what to do. Patient applied ice packs. The patient had patches, blister on top of that and it was not at the injection site. It's where she applied the ice. That was on 15Jan2021. She also didn't sleep well on 15Jan2021. She took ibuprofen but was not running a fever with no itching. Around the skin it was discolored on Jan2021. Patient was scheduled to get the 2nd dose in 3 weeks. Patient took her Pfizer Vaccine (Covid Vaccine) on Friday morning the 15th approximately 8:15 in the morning. Other than a sore arm on Friday she was okay. They told her to put ice pack on it for soreness. So she did that afternoon. On 16Jan2021, she looked at it in the morning It looked like bruise on the arm, not where she gave patient the injection but down a little below her arm and it looked like a bruise and then in the afternoon she was going to take my late night showers I looked at it and it had blister on it. She took Ibuprofen. She didn't have fever. She felt herself today. On 16Jan2021, in the morning she did feel tired and she did take afternoon nap for about 2-3 hours because before that she didn't sleep well. She already knew that she need at least 8 hours. Patient height was reported as about 5'3.Outcome of the event soreness was not recovered while for the remaining events was unknown. The reporter considered the events as non-serious. Information on lot number/batch number was requested. Follow-up (17Jan2021): New information received from a contactable consumer included: new event (sore arm), patient weight, and event details.
66 2021-02-03 headache, fever, chills About 15 hours after receiving the vaccine, I started with muscle aches. Then I got uncontrollable c... Read more
About 15 hours after receiving the vaccine, I started with muscle aches. Then I got uncontrollable chills followed by a high fever. Woke up about three in the morning with a headache over my right eye that was unbearable. Took some Tylenol and woke up this morning and just have a slight headache
66 2021-02-03 fatigue Approximately 6 hours after injection, I began feeling very tired. I was up walking around office w... Read more
Approximately 6 hours after injection, I began feeling very tired. I was up walking around office working on some computer updates and then cam back to my office. About 15 minutes later while sitting at my desk my hand and feet began tingling, then about 10 minutes later my feet became numb, from toes to ankle, both ankles began to swell and had +Edema, and blood pressure was 123/50 , pulse low and undetected on my electronic BP cuff, taken by wrist it was 42, event lasted about 30 minutes, I forces fluids, took a Benedryl, and walked in my office when numbness subsided.
66 2021-02-03 headache Awaken at night with very sore arm and a headache. Took a 500mg Tylenol and was able to go back to ... Read more
Awaken at night with very sore arm and a headache. Took a 500mg Tylenol and was able to go back to sleep. Headache resolved the next morning. Sore arm resolved in about 2 days
66 2021-02-03 influenza like illness, chills Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in he... Read more
Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in her arm and her knees are a little achy; Chills; first dose was on 05Jan2021/ second one yesterday 19Jan2021; Kind of like the flu, like she was hit by a truck; had trouble getting off of the sofa; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), via an unspecified route of administration on 19Jan2021 11:37 at a single dose on right arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER9231, expiry date: Apr2021), via an unspecified route of administration on 05Jan2021 at single dose in left arm for COVID-19 immunization. The patient experienced body aches, mostly in her arm and her knees are a little achy on 19Jan2021 22:00, chills on 19Jan2021, and kind of like the flu, like she was hit by a truck, had trouble getting off of the sofa, all on Jan2021. The patient just got her second Pfizer COVID Vaccine. She experienced nothing with the first dose. She had the second one yesterday 19Jan2021. Last night she had body aches and chills. The chills are completely gone and the body aches are 85%-90% better. She called out of work today, unknowing how long these would last, and her boss told her to get this reported. She does feel better. She was warned of the second dose being more ferocious. She felt great all day. Around 10 PM the body aches started. Kind of like the flu, like she was hit by a truck. She had trouble getting off of the sofa. They told her not to take Advil as it would make the vaccine not work as good. She is used to taking Advil. She confirmed she did not take the Advil. She took Tylenol instead, this morning. She had to go out and get some. The nurse told her when she got the second dose that she would have side effects and she would feel it. Her arm was sore so she circled it around. She went this morning to the pharmacy to get the Tylenol. She is unsure if because she was moving around, or because of the Tylenol that she feels so much better. Maybe like she could even go into work at Noon. She did not take Advil or Tylenol last night, which maybe that is why she was sore. The chills only lasted about half an hour last night and 15 minutes today. Body aches had greatly improved. It is mostly in her arm and her knees are a little achy. They are normally not. She is 85% better. It is going away as we speak. The outcome of the event Body aches, Pain in arm, knee pain was recovering, chills was recovered on 20Jan2021, while for the other events was unknown.
66 2021-02-03 fatigue, nasal congestion Extreme fatigue, muscle pain all over even hair follicles hurt, Entirely snuffed up nose
66 2021-02-03 throat pain tingling in mouth and nose with metallic taste metallic taste also went down throat with heat sensat... Read more
tingling in mouth and nose with metallic taste metallic taste also went down throat with heat sensation and sore throat
66 2021-02-04 cough, chills Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as we... Read more
Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); This is a spontaneous report from a contactable physician (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3283), via an unspecified route of administration on 20Jan2021 at a single dose on Right deltoid for COVID-19 immunization. Medical history included Chronic lymphocytic leukemia with 65% of cells lymph's, low WBC count (13500) otherwise; DM2, A1C usually close to 6.1; HTN. Unspecified concomitant medication taken. The patient previously took nickel and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9331), intramuscular on 31Dec2020 12:15 PM at a single dose on left arm for COVID-19 immunization. The patient experienced chills, rigors, wheezing, shortness of breath, local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop), cough, myalgias on 20Jan2021 23:30. Therapeutic measures were taken as a result of the events which included Benadryl, Aleve, Nebulizer treatment, change in local temperature to help stop rigors. The outcome of the events was recovering. No other vaccine in four weeks. The patient was not pregnant. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
66 2021-02-04 sneezing, throat irritation, runny nose, fatigue Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, ra... Read more
Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, rash on chest/neck, fatigue. Saw medical provider on 2/02/2021 who suspected above due to receiving 1st dose of covid-19 vaccine.
66 2021-02-04 fatigue Extreme tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 66-yea... Read more
Extreme tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 66-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 13:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient did not get COVID prior vaccination and COVID was not tested post vaccination. The patient experienced extreme tiredness on 21Jan2021. No treatment was received. The outcome of the event was resolving. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
66 2021-02-04 headache Headache next day. Started 0900. No prior history chronic headaches
66 2021-02-04 sweating Pfizer-BioNTech COVID-19 Vaccine EUA Drive Thru Vaccination clinic - Within 10 mins of getting the ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Drive Thru Vaccination clinic - Within 10 mins of getting the vaccine, patient reports numbness to her central lips and tip of tongue. Diaphoresis and chest discomfort. Vitals were 157/78, 99, 16, 98% RA. Symptoms slowly started to resolve. 911 called and pt sent to ED. Pt takes Allegra (fexofenadine) daily. Symptoms resolved at 1:15pm. Troponins were normal - low concern for ACS. Diphenhydramine 25mg po on 1121 and prednisone 40mg at 1214. Discharge prescription for prednisone 40mg daily x 3 days.
66 2021-02-04 runny nose, malaise, fatigue, chills Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramp... Read more
Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramps; acid reflux; vomiting; This is a spontaneous report from a contactable consumer, reporting for herself. A 66-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 20Jan2021 at 09:15 (at the age of 66 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included obese from an unspecified date, and cancer in 1998 & 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included letrozole, vitamin (unspecified), Omega, 'TransResve', calcium, 'eld'. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00PM, the patient experienced runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting. The patient did not receive treatment for the events. The clinical outcome of runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
66 2021-02-04 sleepiness facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolv... Read more
facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolved), neck pain (ongoing, possible fibromyalgia flare); ocular irritation redness (ongoing, possibly unrelated)
66 2021-02-05 headache Client complaining of headache and feeling of throat closing immediately after receiving vaccine. RN... Read more
Client complaining of headache and feeling of throat closing immediately after receiving vaccine. RN and MD responded. BP 100/60 HR 95. 50MG IM Benadryl given in R arm. Shortly after administering Benadryl, client reported feeling much better. Continued to monitor. Client left site without further incident.
66 2021-02-05 malaise I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my hea... Read more
I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my heart rate doubled. It took around an hour for my heart rate to slow down again. By bedtime all I had was a sore arm. That was gone within 24 hours.
66 2021-02-05 chills Mild to Severe migraine still have it. Chills and stiff neck.
66 2021-02-06 chills, fever, headache, fatigue Tiredness (no energy) Headache Chills Fever 107 Injection site redness Nausea
66 2021-02-07 fatigue 1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Bena... Read more
1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Benadryl given with good effect. C/O nausea and decreased appetite 1/30 received PRN Zofran with good effect. No further complaints 2/1
66 2021-02-07 chills, fever, headache First Vaccine - produced fever, chills, headache, dizziness, nausea - lasted 2 days - Vaccine was a... Read more
First Vaccine - produced fever, chills, headache, dizziness, nausea - lasted 2 days - Vaccine was administered Sunday at 3:20 PM and I was sick Monday and all day Tuesday - by Wednesday I was fine Second vaccine was January 31st at 3 PM - the next morning I woke up - got in the shower - got nauseous dizzy and fell breaking my left leg and left ankle. I still had nausea for 6 days and headache for 6 days - seems better today
66 2021-02-07 fatigue contracted Covid after my 2nd dose, 3 days to be exact; contracted Covid after my 2nd dose, 3 days t... Read more
contracted Covid after my 2nd dose, 3 days to be exact; contracted Covid after my 2nd dose, 3 days to be exact; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL3246) at single dose at right arm on 14Jan2021 for covid-19 immunisation, administered at hospital. Medical history included rheumatoid arthritis, allergies to morphine and related, PCN, sulfa, quinidine, Xeljanz. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included: upadacitinib (RINVOQ), folic acid (FOLIC ACID), ropinirole hydrochloride (REQUIP). The patient previously received the 1st dose of bnt162b2 (BNT162B2, Lot # EJ1685) at single dose at right arm on 26Dec2020 03:00 PM for covid-19 immunisation, administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced contracted Covid after her 2nd dose, muscle aches and fatigue 3 days to be exact on 17Jan2021 17:00, Covid test result positive on 22Jan2021. Since the vaccination, the patient has been tested for COVID-19 (nasal swab): positive on 22Jan2021. No treatment was received for the adverse event. The outcome of Covid test result positive was unknown, of the other events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported lack of efficacy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
66 2021-02-07 headache, fever, fatigue vomit once shakes
66 2021-02-08 chills, fatigue, fever Fever, chills, extreme body pain, extreme fatigue
66 2021-02-08 chills, fatigue Had normal side effects of complete ftigue, body aches, chills for 2-3 days after vaccine. On day 5 ... Read more
Had normal side effects of complete ftigue, body aches, chills for 2-3 days after vaccine. On day 5 I totally lost my sense of smell and taste. I can find no where else to report this and do not see this listed as a vaccine side effect anywhere.
66 2021-02-08 chills I receive my second vaccination for Covid on January 4, 2021. Less than 36 hours later I experience... Read more
I receive my second vaccination for Covid on January 4, 2021. Less than 36 hours later I experience a rapid heart rate (110 - 128) and shortness of breath not related to activity. I had anticipated body aches, chills etc and did have those as well. Over the course of 4 - 5 days those resolved but my tachycardia and shortness of breath have not. I waited another week to see if it would improve and when that did not occur I made an appointment to see Cardiologist because quite frankly, I was fearful of my symptoms. My lungs remain clear, I have no difficulty taking a deep breath and my SAO2 is high 90's. I had my annual physical 1/18/2021 and my lab work was normal as was my EKG. I have never had shortness of breath and my heart rate was normally in the 70 - 80's range at rest. Doctor ordered testing and the results are in My Chart. I had a Echo/Stress/Echo which was normal. My EF was 60% and in spite of my extreme shortness of breath on the treadmill, there was no ischemia induced. Bp was elevated initially and during the test but returned to 130's/70's in recovery phase. SAO2 was 97% to 100%. I did a home sleep study on 1/31/2021 with results pending. Doctor stated there was nothing on my testing that would account for my symptoms. At my initial visit (1/26/2021)he started me on low dose Cardezem 120mg to address my heart rate. My heart rate has improved with Cardezem (increased to 240 mg 2/2/2021) but my shortness of breath with minimal exertion has not. I believe Doctor plans to order a PFT next. Because of the timeframe for new onset symptoms and my Covid 19 vaccination, I wanted to reach out to you for guidance. ? Second Covid Vaccination 1/4/2021 ? Shortness of breath and tachycardia 1/5/2021 ? Scheduled appointment with Cardiologist for 1/21/2021 and it was cancelled and rescheduled for 1/26/2021 ? Dr. appointment 1/26/2021, started on Cardezem 120 mg qd ? 1/31/2021 Sleep Study completed, results pending ? 2/2/2021 Echo/Stress/Echo completed, Cardezem increased to 240 mg qd ? PFT order pending ? Follow up with Doctor scheduled for 2/18/2021
66 2021-02-08 throat irritation Scratchy throat Wheezing Shortness of breath
66 2021-02-09 headache Death. I actually not sure which Covid Vaccine she took. I just know the date and time she took it ... Read more
Death. I actually not sure which Covid Vaccine she took. I just know the date and time she took it at her local school where she worked. Died in her sleep after complaining of a headache. I talked to her around 5pm on sunday through a videochat and she seemed happy and well. But a local friend commented that she had complained of a headache late in the afternoon.
66 2021-02-09 sweating, headache Did the adverse event start after the first or second vaccination? both Date and time of vaccinatio... Read more
Did the adverse event start after the first or second vaccination? both Date and time of vaccination: (list both if they received both shots): 1-6-2021 @ approx 10:15am Pfizer LOT # EL3246 1-27-2021 @ approx 11AM Pfizer LOT # EL9262 Date and time adverse event started: 1-31-2021 at approx 8:30am, cold hands/feet, nausea, HA, pain to bilateral eye, mid lower back aches radiating to upper. today 2-5-2021 losing voice, all symptoms are reported to be intermittent Pfizer LOT # EL3246
66 2021-02-09 headache Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2... Read more
Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2nd dose pfizer vaccine given; after obtaining chart pt reports "feeling flushed, and then redness/rash on chest, and blood pressure go up". Pt given epi during rapid response; Pt reported a headache at this time. Pt denies dizziness, nausea, diarrhea, sob, no facial swelling, no lip swelling; no dysphagia; RR equal non-labored; Alert and orientated x4;
66 2021-02-09 chills, headache, fatigue chills; fatigue; headache; soreness in her arm; This is a spontaneous report from a contactable cons... Read more
chills; fatigue; headache; soreness in her arm; This is a spontaneous report from a contactable consumer reported for herself. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PFREL1283), via an unspecified route of administration on left arm on 13Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included diabetic, highwood pressure, kidney issues. The patient's concomitant medications were not reported. The patient previously took hydrocodone, morphine, oxycontin, metformin, trulicity, all experienced drug allergy. The patient experienced chills, fatigue, headache, soreness in her arm, all on 13Jan2021 16:00 with outcome of recovered on 14Jan2021 16:00. This last for about 24 hrs. No treatment received for these events.
66 2021-02-09 cough, fever fever; persistent cough; This is a spontaneous report from a contactable consumer (patient herself).... Read more
fever; persistent cough; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 22Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies and was not pregnant. She had not been diagnosed with COVID prior to vaccination. Concomitant medications included metformin 500 mg and hydrochlorothiazide 12.5 mg. The patient experienced fever a persistent cough and fever on 22Jan2021 19:00. No treatment was received for the events. The outcome of the events was recovering. The patient was not tested for COVID post vaccination. Information on the lot/batch number has been requested.
66 2021-02-09 headache headache; heart-pounding, racing heart beat,; dizziness; feelings of passing out; This is a spontane... Read more
headache; heart-pounding, racing heart beat,; dizziness; feelings of passing out; This is a spontaneous report from a contactable consumer. A 66-year-old non-pregnant female received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9262), via an unspecified route of administration in the left arm on 23Jan2021 10:00, at 0.3ml, single for covid-19 immunization.The patient medical history was not reported. Patient is an Rh Neg A blood type and did not have Covid, as she's been isolated for a year. Concomitant medication included gabapentin, paroxetine hydrochloride and atorvastatin. On 23Ja2021, after half an hour (10:30) of receiving 1st dose of the vaccine, patient experienced heart pounding, racing heart beat, dizziness, feelings of passing out. These symptoms lasted up to 3 hours. Patient sat her my car outside of the an emergency parking lot for 3 hours because she couldn't drive home during these symptoms. Patient was on the verge of going into emergency care. For the remainder of the day, patient's sitting heart beat was at 90. The next day, 24Jan201, she felt better but have on and off slight headache. She did not plan on taking the 2nd dose. The outcome of the events was recovering. The patient has not tested positive for Covid-19 post vaccination.
66 2021-02-09 chills, fatigue sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours;... Read more
sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours; swollen lymph nodes left side; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left arm on 22Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included heart disorder (heart disease), hypertension, and obesity. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient received other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sever joint pain hands, arms, shoulders, extreme fatigue, nausea, muscle fatigue, chills (for 6 hours as reported), swollen lymph nodes left side all on 23Jan2021 02:00 with outcome of recovering. The patient did not received any treatment for the events.
66 2021-02-16 headache Within 15-minutes, the patient reported a "pulsating sharp pain" behind their right eye. EMS evaluat... Read more
Within 15-minutes, the patient reported a "pulsating sharp pain" behind their right eye. EMS evaluated the patient on-site and they were found to be hypertensive (173/88). The patient proceeded to a emergency department. In the ED, the patient remained hypertensive with a mild generalized headache. They reported that their eye pain is constant but comes in waves of higher intensity. Differential diagnosis was possible stroke due to right-sided hemianopsia and right-sided ptosis. Patient was admitted and evaluated. Aspirin was administered and blood pressure was monitored prior to discharge.
66 2021-02-17 dehydration Enlarged or inflamed heart, lungs full of fluid, myocarditis, vomiting, dehydration
66 2021-02-17 fever, sweating, fatigue, headache Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest... Read more
Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest pain; body ache; high fever; fatigue; profuse sweating; belabored breathing; hot; butterfly rash of face; This is a spontaneous report from a contactable physician (patient). A 66-year-old female (Not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 11Feb2021 14:30 at single dose for covid-19 immunization. Medical history included hypothyroidism, hypertension, hypercholesterolemia, breast cancer, osteoporosis, ligamentous RA, degenerative joint disease (DJD). The patient had known allergies to cilantro, cephalosporins, all morphine and morphine derivatives, Herceptin, astralogous mushrooms, gadolinium dye, fentanyl. The patient's concomitant medications reported as other medications in two weeks was yes.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, eye pain, earache on side of shot, itching both arms, severe jaw pain, severe chest pain, body ache and high fever &fatigue - profuse sweating, belabored breathing hot butterfly rash of face on 12Feb2021 at time of 06:00 AM. AEs resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient received Prednisone 80 mg and Benadryl 50 mg as treatment. Prior to vaccination, the patient was diagnosed with COVID-19. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab and PCR test: negative on 09Feb2021. The outcome of events was recovering. Information on Lot/Batch has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-02-18 sleepiness dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issue... Read more
dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issues (falling into her right side); This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiration Date: May2021), via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included cancer survivor, type 2 diabetes mellitus, and surgery of the left hand in 2020. Concomitant medications included the second dose of varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on 12Jan2021 for immunization. The patient previously received the first dose of the varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on an unknown date for immunization. On 02Feb2021, the patient experienced swelling and pain in arm and felt sleepy. On 03Feb2021, the patient fell on the table due to dizziness. The patient had to use her cane more to get around. On an unknown date in Feb2021, the patient had weakness in the right eye and balance issues (falling into her right side). The clinical outcomes of the dizziness, swelling in the arm, and weakness in the right eye were recovering; while that of the pain in the arm was not recovered. The clinical outcomes of the sleepiness, fall, and balance issues (falling into her right side), were unknown.
66 2021-02-21 fatigue, chills, headache, malaise, fever Body aches, fever 99.8, chills, chattering teeth, general feeling unwell. Pounding headache, fatigue... Read more
Body aches, fever 99.8, chills, chattering teeth, general feeling unwell. Pounding headache, fatigue, really sore arm. Night sweats. Lasted about 48 hours. I'm still waking up with a pounding headache every morning. Still lingering sense of unwellness.
66 2021-02-21 body temperature increased, chills, sweating Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through th... Read more
Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through the pharmacy LTC partnership vaccination program. Resident had no adverse effects until around 8:00 pm she began complaining of body aches, and chills, Tylenol was given at this time. Around 9:30pm resident was sleeping in bed. Around 12:00 am the CNA called nurse into room to assess resident as the resident stated she did not feel good. Temperature at that time was 102.2, and vomiting. RN came to assess @ 1220 am She was noted to be vomiting, diaphoretic, pale and having trouble breathing. Temp was 97.3 after vomting, Pulse 53, Resp 20, o2 sats were 40-45%, unable to obtain Blood pressure, Applied 5 L of oxygen at this time and had LPN call 911 immediately. Resident was repsonsive and able to follow staff members instructions but was only answering yes or no simple questions at the time time of assessment. Paramedics arrived at 0040 and resident was sent to Hospital. @ 0130 ER nurse called to nursing facility to notify resident had coded in the ER and passed away @ 0110.
66 2021-02-22 throat irritation 2/17/21-Anaphylaxis-15:17pm (within 30 min waiting period post vaccine), throat scratchy, moved to a... Read more
2/17/21-Anaphylaxis-15:17pm (within 30 min waiting period post vaccine), throat scratchy, moved to assessment area, HR 100, labored resp, O2 6L NRmask initiated. (ct reports similar reaction as previous anaphylaxis). 15:22pm-911 called, HR 120, Epi 0.5ml admin. 15:37pm transfer via ambulance to hospital. 02/18/2021 evening, f/u call to client by PHN, throat still feels 'weird', ct reports had 2nd Epi in ambulance, 3rd Epi in ER, plus Benedryl gel, Ct then recalled had anaphylaxis reaction in past to bee sting had ER visit, tx w/ steroids at that time. PHN recommended ct talk with PCP re epi pen order.
66 2021-02-22 head discomfort, body temperature increased, fatigue, influenza like illness, sweating About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints ... Read more
About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints and having breathing problems. i was just sic. or like i had the flu or covid again. went on through the night. was up all night. my arm was just killing me. The next morning i was full on sick. the nausea was intense my temp throughout day was 99.6 and 99.9 . out of breath. That night i went to bed and woke up at midnight and was drenched my hair was soaked Got up at showered. at the 3:30 woke up again totally drenched. yesterday i woke up and 6:00 am i was feeling better but still trouble breathing but everything else was gone. I was tired still. About 10:30 yesterday Everything was fine. I do still have a little trouble breathing but not as bad.
66 2021-02-22 chills Chills, feeling cold
66 2021-02-22 headache, chills Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day ha... Read more
Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day has vomiting, chill and weakness which lasted 6 days
66 2021-02-22 fever, chills, headache, nasopharyngitis Headache, felt like I was starting a bad cold , chills, low grade fever and every joint ached for 36... Read more
Headache, felt like I was starting a bad cold , chills, low grade fever and every joint ached for 36 hours. Then it just went away.
66 2021-02-22 headache, fatigue Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet... Read more
Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet, itchy rash all over torso, heart palpitations and pain.
66 2021-02-22 lethargy This was the second dose in the vaccine series. The patient reported doing well for the first dose. ... Read more
This was the second dose in the vaccine series. The patient reported doing well for the first dose. A few minutes after receiving her second dose, the patient started to complain of lightheadedness, lethargy, arm weakness. She reported she did have an anaphylactic reaction to the H1N1 vaccine . Patient reported about 10 minutes after she received the vaccine she was starting to feel better- less lightheaded and was gaining arm strength. She was moved to a chair and she could not support her weight. EMS was called to the scene and she was transported to the ER.
66 2021-02-22 fatigue, chills Two days after vaccine: extreme fatigue and chills. Symptoms lasted just that one day. Four-five... Read more
Two days after vaccine: extreme fatigue and chills. Symptoms lasted just that one day. Four-five days after vaccine, full-body itching. Just thought it was my eczema flaring up (it's worse in the winter). After about 2 weeks, developed red areas on my body (torso, arms, legs and feet) - self-monitored - but got progressively worse. Dermatologist believes it is eczema aggravated by the vaccine. Provided a cortisone injection (right arm). Will monitor for two weeks to determine improvement or lack of improvement.
66 2021-02-22 dehydration client says she was in distress prior to taking the vaccine because she had stood for over an hour i... Read more
client says she was in distress prior to taking the vaccine because she had stood for over an hour in line waiting to be seen and she had a double mask on. She says by then she was dehydrated and feeling faint. She has a history of atrial fib off and on, which she takes medication for. She says she feels like she almost had a stroke and Nurse Pract told her she had a full blown panic attack. She was allowed to sit down and rest and rehydrate and eat and she felt better.
66 2021-02-22 influenza like illness, sleepiness flu like symptoms, no fever/ chills, sleepy, couldn't stay awake,
66 2021-02-23 fever I have a fever of 100.3, is that normal; This is a spontaneous report from a contactable consumer, t... Read more
I have a fever of 100.3, is that normal; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 26Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient stated, "I have a fever of 100.3 F, is that normal in Jan2021." The outcome of the event fever was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
66 2021-02-23 headache Massive headache
66 2021-02-23 chills, fever The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to tha... Read more
The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to that dose. (Had arm pain and mild chills and fatigue). The day after dose two above noted fullness and discomfort in feet, On the second day after, had early erythematous (non-puritic) rash, mild multi-joint discomfort, 100 deg fever, and shaking chills. Doctor on call said to use judgment on starting Prednisone, since hope that this would stabilize. However, progressed and at 9am on the third day after vaccine started prednisone 40mg. At the worst, had to be dressed by husband due to pain and stiffness in upper extremities, widespread erythematous rash, fullness of skin, joint swelling.
66 2021-02-23 headache Tongue feels thick 8:05 slight headache 0819 headache better. Lungs clear b/p 122/78 pulse 68 respi... Read more
Tongue feels thick 8:05 slight headache 0819 headache better. Lungs clear b/p 122/78 pulse 68 respirations 18. Patient cheerful and talkative, color pink. 0821 Swelling in tongue better. Denies shortness of breath. 0824 left arm feels tight. 0831 patient denies further care. States she going to have a work up for MS. Her sister has MS. Patient refuses further medical care here and states she is feeling ok. Tongue is feeling less thick and arm is less heavy. Patient states she would like to leave with her husband to go home. Patient is talkative and cheerful at this time. Speech is clear(husband states she had anxiety about getting the vaccine) Advised to call MD or 911 if needed.
66 2021-02-23 body temperature increased, cough, headache, fever, chills Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headac... Read more
Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headache (which I never get) low grade fever; Day 3:Hives and itche sin addition to dry cough; Day 4 - Hives deep red, full torso and back, top of legs and pubic areas. Deep and extreme.Chills Steady, Night Hard vomiting, Hives, Soaking Night sweats (never had before), Temp 101.5. Day 5 Morning - rapid test negative, fever 99.9. Started Ibuprofen Day 6 - Hives same - extremely dark and red. itchy. # day swab test was POSITIVE. Put on Prednisone. Day 7 - Fever normal, Hives going down but still ugly. Not sure whether this was really an adverse event as it was a positive test result AFTER the vaccine. I am an allergig person whose eosinophils report for duty quickly and obviously too much! I will assume that they were the result of the virus and NOT the drug as the drug does not have an active virus included. Your call.
66 2021-02-23 fever, fatigue fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root ... Read more
fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root canal on day 4 with "dying nerve", butterfly (lupus like) rash on face day 4, "covid arm" day 4 with tennis ball size red knot around injection site that extended down arm over next several days, winded for several days, fatigue and shortness of breath.
66 2021-02-24 headache, chills Dizziness, vomiting, diarrhea, headache, chills.
66 2021-02-24 nasal congestion Patient received her second dose of Pfizer vaccine today at 1230 today. Approximately 15 minutes la... Read more
Patient received her second dose of Pfizer vaccine today at 1230 today. Approximately 15 minutes later at 1246 she started to feel a flushed face, nasal and sinus congestion and stated that her throat felt as if it was swelling. Benadryl 50 mg orally was administered. VS were checked BP 128/80, HR 82. Pt stated she was feeling improved at 1315 and stated her throat felt much better, denies feeling swelling in her throat. No evidence of mouth, tongue or lip swelling, no evidence of angioedema. No evidence of respiratory distress, no wheezing, speaking in full sentences. No rash. Reassessment @ 1345: One hour after patient received benadryl she stated she felt much improved aside from mild body itching. Requesting to leave with husband. Advised to continue benadryl 50 mg every 6 hours as needed for symptomatic and follow up with her primary care doctor and allergist.
66 2021-02-24 headache, fatigue, chills Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the sym... Read more
Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the symptoms. Fatigue (not able to complete the routine daily walk of 3 miles) the day after vaccination for one day.
66 2021-02-24 headache Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing.... Read more
Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing. These symptoms came in waves and is a normal reaction I get with medication I am sensitive to. However because I not having a normal reaction, I was told to go to an emergency room for a EKG. I knew this wasn?t a heart event, but a reaction to the vaccine. It is a normal reaction for me. I?ve dealt with it most of my life.
66 2021-02-24 fatigue morning fatigue - bedrest, recovered by mid-afternoon neck rash, watery eyes - began a week after f... Read more
morning fatigue - bedrest, recovered by mid-afternoon neck rash, watery eyes - began a week after first shot. took loratadine this morning, now neck not itchy, eyes not watery. also had covid arm a week after first shot - went away in 3 days.
66 2021-02-25 fever, sweating, headache, chills headache; sweats; feverish; chills; low blood sugar symptoms; weakness; This is a spontaneous report... Read more
headache; sweats; feverish; chills; low blood sugar symptoms; weakness; This is a spontaneous report from a contactable healthcare professional. This 66-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot EL3247) on 24Jan2021 at 11:15 AM at left arm for COVID-19 immunization in hospital. Historical vaccine included first dose for BNT162B2 (lot EK5730) on 02Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Medical history included hypo thyroid, parox afib, high blood pressure (HBP), obesity and allergies: bupropion hydrochloride (WELLBUTRIN), soy. Concomitant drugs included metoprolol, apixaban (ELIQUIS), fluoxetine hydrochloride (PROZAC), losartan potassium (COZAAR), thyroid (ARMOUR THYROID) and more. On the day of injection on 24Jan2021 at 04:00 PM, the patient had low blood sugar symptoms, weakness, which resolved in a few hours. On second day, symptoms of low Blood sugar, sweats, feverish, chills, on third day feverish symptoms of low blood sugar, sweats, feverish, headache. No treatment was received. The outcome the events was unknown.
66 2021-02-25 head discomfort pressure in temple of head, left eye issues, upper back pain left side,heavy body weight
66 2021-02-26 headache Headache Diarrhea
66 2021-02-26 fatigue, headache Headache for 5 days. Extremely sore arm for 5 days. Unusual Fatigue 3 days.
66 2021-02-26 headache Headaches
66 2021-02-26 fatigue, chills, headache Nausea Achy Chills Headache Sore arm at site Fatigue
66 2021-02-26 fever, chills Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank... Read more
Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank about 20 oz of Crystal Light Peach Tea over night. Got up at 5am to get more to drink and find another place to rest. went into my kitchen to fill container and passed out. Woke a few seconds later. Left side of my forehead was bruised and swollen above left eye. Over the last 4 days both eyes an cheeks are bruised. All day felt like I had the flu without the fever. I did not go to the hospital.
66 2021-02-27 fever, chills Chills, progressed to fever of 100 F, muscle aches, swelling and discomfort in left armpit
66 2021-02-27 headache, fatigue Headache Fatigue-minor Sore arm
66 2021-02-27 chills Insomnia, sleeplessness and brain fog starting one week after vaccine and lasting for one week. Sle... Read more
Insomnia, sleeplessness and brain fog starting one week after vaccine and lasting for one week. Sleeplessness was worse each night, with inablilty to sleep even with 50 mg of Benadryl and Valium. Did sleep about two hours a night with those meds but continued to be wide awake all day also. My body felt like it hadn't slept but was unable to do so. These symptoms left me suddenly with a severe chill and the brain fog litarally lifted and was gone. The next week following developed mild red itchy skin that comes and goes on hands and torso and that symptom persists. I am now able to sleep.
66 2021-02-27 fatigue Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and... Read more
Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and again the day after. Injection site became red and itchy within an hour of injection; redness has spread down the arm and continues to itch on day 3. This did not occur with first jab. Loss of appetite, fatigue, and brain fog, the day of and next day.
66 2021-02-28 fatigue, nasal congestion, headache 2/25/2021 9:30am minor pain at injection site upper left arm 2/26/2021 1:30pm dull headache, backsid... Read more
2/25/2021 9:30am minor pain at injection site upper left arm 2/26/2021 1:30pm dull headache, backside of head and very tired 2/26/2021 5:30pm minor tongue swelling, minor throat and nasal passage constriction 2/27/2021 9:30am increased tongue swelling, increased throat and nasal passage constriction, minor difficulty swallowing, minor facial swelling 2/27/2021 6:30pm treatment at ER/Urgent Care with oral Prednisone tongue swelling started to decrease, released with Rx for Benadryl, Pepcid, Prednisone and EpiPen 2/27/2021 8:00pm started Benadryl + Pepcid. Tongue swelling decreased more, throat and nasal constriction starts to alleviate 3/1/2021 9:00am facial swelling continues with added redness to left side face and spot under right eye socket 3/1/2021 11:20am family doctor visit
66 2021-02-28 nasopharyngitis Before I left the hospital parking lot I could taste the drug in my moth. By the time I got home ... Read more
Before I left the hospital parking lot I could taste the drug in my moth. By the time I got home I had the dry heaves. I was also alternating hot and cold. This went from about 7 pm to 8 AM the next day. That day I had a head ache which I normally do not have.
66 2021-02-28 sweating Client c/o general flush feeling dryness of mouth and sweating. Client verbalized that symptoms occ... Read more
Client c/o general flush feeling dryness of mouth and sweating. Client verbalized that symptoms occurred immediately after receiving vaccine. Client seen and assessed by EMS an Vital signs are B/P 147/82, HR 80, O2 100%. Pt. voice that her anxiety level increased when receiving vaccine but now has decreased and symptoms decreased during observation. Second round of vitals B/P 139/82, HR 76, O2 99%. Client then verbalized that she is no longer having the sensation and asked to go home after 45 minutes of observation. Client denied the need to go to or be taken to the hospital and was cleared to go home by EMS. No physical reaction noted.
66 2021-02-28 head discomfort Face flushing, " rolling hot flashes", head fullness. This lasted about 10 to 15 minutes, intermitte... Read more
Face flushing, " rolling hot flashes", head fullness. This lasted about 10 to 15 minutes, intermittently then dissipated.
66 2021-02-28 headache, fever, chills Fever, chills, nausea, vomiting, migraine aura, headache - onset 20 hours after dose. Took Tylenol a... Read more
Fever, chills, nausea, vomiting, migraine aura, headache - onset 20 hours after dose. Took Tylenol and fever reduced from 99.9 to 98.6. Head ache persisted for 12 hours following onset. Remainder of side effects resolved within 6 hours of onset.
66 2021-02-28 headache, fever, chills Headache in the back of my neck radiating up into the back of my head; Headache in the back of my ne... Read more
Headache in the back of my neck radiating up into the back of my head; Headache in the back of my neck radiating up into the back of my head; Projectile vomiting; Dry heaves; Fever; Chills; Muscle spasms; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported) on 26Jan2021 (10:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included allergy-induced asthma; Celiac disease; bradycardia; was a pacemaker user (for bradycardia); sulpha allergy; and latex allergy. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), alprazolam, lisinopril, montelukast, and other unspecified medications. The patient previously took cephalexine, and had allergy. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on the left arm on 07Jan2021 (when the patient was 66 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 26Jan2021 (23:00), the patient had headache in the back of the neck, radiating up into the back of the head; projectile vomiting; dry heaves; fever; chills; muscle spasms; and swollen glands. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache in the back of the neck, radiating up into the back of the head', 'projectile vomiting', 'dry heaves', 'fever', 'chills', 'muscle spasms' and 'swollen glands', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
66 2021-02-28 cough Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room.... Read more
Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room. While she was sitting down patient started to complain of itchiness at injection site and felt like needed to scratch arm about 3 times, lasted only a minute. Started to feel lightheaded about 5 minutes after sitting down in waitng arae and notified observer. Felt weak and lighthed. Offered a wheelchair but refused and able to walk back to examination room. Taking Topamax this am for headaches, no other medications. Has COPD. Caring for adult daughter who is disabled and her husband left for a trip last Wednesday and back tonight. Patient often has interrupted sleep and up every couple hours with daughter. She has another daughter who will come and help at times but no one else around due to COVID concerns. Ate granola, blueberries, yogurt for breakfast this am Offered water in exam room, crackers and apple juice but patient refused. States has IBS and not want to eat other things In exam room feeling anxious, but the lightedness disappeared within 10 minutes. B/P decreased to 128/72. No nausea, abdominal pain, SOB. Denies any new illness. Has chronic cough with COPD Patient alert and oriented during entire visit and pleasant in conversation.
66 2021-02-28 cough Pt given Pfizer COVID-19 Vaccine (first dose) around 1100. Waited 30 minutes post-vaccination observ... Read more
Pt given Pfizer COVID-19 Vaccine (first dose) around 1100. Waited 30 minutes post-vaccination observation period and left vaccine clinic. Pt reports she noted SOB going up the stairs to leave the building. Reports she waited upstairs for a while and symptoms did not resolve.. Pt reported back to healthcare facility to report symptoms at 11:45. Brought to observation area, vital signs checked (125/76, HR 60, O2- 99%). Reports SOB/tightness in chest continues at rest- Emergency Response Team is called. 1152- develops thickness in throat and coughing that becomes progressively worsening. Emergency Response Team arrives, Provider advises Epi-Pen. Administered Epinephrine Auto-Injector at 1155. Pt is transported to ER by Emergency Response Team.
66 2021-02-28 fever Running a fever of 100.3; This is a spontaneous report from a contactable consumer (patient). A 66-y... Read more
Running a fever of 100.3; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) in Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient was running a fever of 100.3 (unit was not reported). The outcome of the event, 'fever', was unknown. The patient would want to know if the fever was normal, and if she could take ibuprofen. Information regarding lot/batch number has been requested.
66 2021-02-28 fatigue Slight dizziness; body ache; Tiredness; This is a spontaneous report from a contactable nurse (patie... Read more
Slight dizziness; body ache; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 66-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), intramuscularly on the left arm on 27Jan2021 at 10:00 at a single dose for COVID-19 immunization. Medical history included diabetes borderline. The patient has no allergies to medications, food, or other products. Concomitant medications included metformin (METFORMIN), and lorazepam (LORAZEPAM). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced slight dizziness, body ache and tiredness on 27Jan2021. No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. No treatment was administered for the events. The events resolved on an unknown date. Information on the lot/batch number has been requested.
66 2021-02-28 cough, fatigue, headache Started with extreme exhaustion 1 hour after vaccination, very loose stools X3 days, extreme joint p... Read more
Started with extreme exhaustion 1 hour after vaccination, very loose stools X3 days, extreme joint pain 1 1/2weeks- pain continues until present, headache for 12hours with headache off & on continues, cough x 5 days
66 2021-02-28 fever, chills, headache tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come... Read more
tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old) as a single dose for covid-19 immunisation . Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas). The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks. On 27Jan2021 The patient reported she was sick last night, tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.
66 2021-03-01 headache, fever, chills 2/25/21 swelling and redden around arm. On 2/26/21 headache, body aches, chills and fever - 102.
66 2021-03-01 fever, sleepiness, fatigue, headache, throat pain Day of vaccine: Tiredness, headache, slept for 3 hrs Following evening: aches, fever, sore throat, c... Read more
Day of vaccine: Tiredness, headache, slept for 3 hrs Following evening: aches, fever, sore throat, coughing, can't sleep for 8 hours, wake up at 3:30 am.
66 2021-03-02 headache, fever, fatigue Fever 101, aches, awful headaches, nausea, threw up 5 times, very tired, fatigue. Lasted 4 days. H... Read more
Fever 101, aches, awful headaches, nausea, threw up 5 times, very tired, fatigue. Lasted 4 days. Headaches have not gone away since my first symptoms of Covid on December 24, 2020
66 2021-03-02 chills, headache Some achey-ness and a bit of chills. Bad migraine with very frequent (every 20-30 seconds) bolts of... Read more
Some achey-ness and a bit of chills. Bad migraine with very frequent (every 20-30 seconds) bolts of very sharp pain in my head in addition to migraine. This went on for 30 hours. No treatment...just waited it out and used cool packs on head. Also had very enlarged tender nodes under my left arm which are going away.
66 2021-03-02 fatigue, malaise terrible gas and bloating - starting 12 hours after injection and lasting 1 day, rapid and irregula... Read more
terrible gas and bloating - starting 12 hours after injection and lasting 1 day, rapid and irregular heart rhythm - beginning 40 hours after injection - lasting 6 hours, extreme tiredness - day 7 & 8, lower back and hip pain - day 7 and currently day 10, general feeling unwell - most days
66 2021-03-03 throat irritation, cough 1:30 pt received vaccine and then walked to observation area without event. 1:45 pt reports feeling... Read more
1:30 pt received vaccine and then walked to observation area without event. 1:45 pt reports feeling a "tickle in her throat that makes her want to cough". Noted that pt clears throat frequently. No other s/s reaction noted. VSS BP 122/68, HR 82, Resp 12. Pt given water and by 1:47 she reports no longer feeling the tickle. She reports a new autoimmune disorder (erythema nodosum) within the last few months. She is not on any meds for this diagnosis after being treated with prednisone previously. 1:52 Pt reports not needing to cough "tickle just maybe a little there". Pt drinking water and given snack and tickle does not clear. 2:07p pt reports tickle has fully returned, she is clearing her throat and occasionally coughing. Reviewed case with pharmacist. 25mg liquid Benadryl given to pt, drank and tolerated well. 2:15 pt reports "tingle is hardly there", she is no longer coughing or clearing her throat. 2:27 pt reports tingle is no longer there at all. Recommended pt call provider and notify them of potential reaction to the vaccine and discuss if pt should have further consults and/or if the pt should receive the 2nd dose of the Covid vaccine. We also discussed side effects vs signs of reaction. Pt agrees to call 911 immediately if any s/s of reaction. She also agrees to pull off the road if any tiredness develops from the Benadryl. She reports a history of Benadryl making her energetic not tired. 2:35Pt denies s/s reaction. Discharged from observation area.
66 2021-03-03 fatigue, headache, cough, chills, throat pain Cough; Chills; he came home and said he felt like crap, really bad, she said she did too; they are b... Read more
Cough; Chills; he came home and said he felt like crap, really bad, she said she did too; they are both so fatigued, so tired/exhausted; sore throat; major headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. This consumer reported similar events for two patients. This is the first of two reports. A 66-year-old female patient (wife) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EN5318), via an unspecified route of administration on 27Jan2021 13:00 at single dose on the left upper arm for COVID-19 immunization, reported as "doesn't want to get the COVID". There were no medical history and concomitant medications. The reporter said that she and her husband got first dose of COVID vaccine last week (27Jan2021) and they both got sick, had a major headache in Jan2021, cough and chills both on 27Jan2021, and also she wanted to know if she and her husband can take the second dose, scheduled on 17Feb2021. Patient stated that major headache went in on a "Wednesday". Her husband and her did, and went through vaccination portal, to get an appointment, appointments were very trying, as they were to do all healthcare providers first, which is understandable, and then the vaccine. They were trying to make it available for teachers, as they are going back to school, in school learning in March, so all teachers were the next step and then also anyone over 65 was able to go on the portal with the state to get an appointment to go and get a vaccination. She and husband have a daughter who was a teacher, and she said to go on the portal to get the shot, and they said they didn't have access to it, so she went on the site, and they got it in on 27Jan2021. The headache occurred after the 27Jan2021. Patient stated that as soon as they got home, her husband works full time, she lost her job in October, and she was home and he said "how are you feeling", he went back to work, patient came home and said she felt alright except for her arm then she got a really bad headache. The husband came home and said he felt like crap, really bad, patient said she did too, she was the type of person she never ever gets sick and if he was sick she does not say she was sick. Patient had such a bad headache, she thought her brain was ready to jump out of her head. Headache subsided after two days. She has recovered completely from the headache. Cough started almost immediately (27Jan2021), but patient did not cough today, but did last night, it was usually a deep cough. Today she has not coughed at all. Chills started probably that evening (27Jan2021), when she came home, the shot was around 1PM and chills started in the evening, and went away probably, they had gone back and forth for around two days but they were gone, she has recovered completely. Patient wished to add that they were both so fatigued, so tired, almost like, both she and her husband were very active, when they were down for the count, really exhausted, after this whole vaccination experience, both of them have been exhausted, to the point of going to bed at 8, and they were not 8:00 going to bed people. she doesn't want to be a pain, as she knows people have legit concerns, Patient doesn't want to waste time, her main concern is the second vaccination, if she does not have to, or is suggested to not take it, or her husband, she doesn't want the second vaccination to cause more severe side effects. The patient further reported, that they both experienced major side effects: chills, headaches, sore throat, major cough, fatigue that was "just unbelievable, both of us are exhausted." Her second dose is scheduled on 17Feb2021 and his husband is scheduled on 20Feb2021. Patient was asking "if this was after the first dose, what's going to happen after the second dose?". Outcome of the events headache and chills was recovered in 2021 for cough was recovered on 02Feb2021 while for other events was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021105012 same reporter/drug, similar events, different patient
66 2021-03-03 headache, fatigue DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THES... Read more
DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THESE SIDE EFFECTS CONTINUED ALONG WITH EXTREME FATIGUE, NO APPETITE, LOSS OF 6 LBS IN 6 DAYS, WEAKNESS. SYMPTOMS STILL PERSISTING ON DAY 8.
66 2021-03-03 chills, headache, fatigue, body temperature increased I had a headache within an hour of the injection. The next day, my left arm hurt (which was to be e... Read more
I had a headache within an hour of the injection. The next day, my left arm hurt (which was to be expected), muscle aches and pain, headache still, fatigue, shortness of breath and chills. By 8:30 pm I had a temperature of 101.7. I took some Tylenol and took my temperature again at 10:00 pm. It was 100.8. The next morning (3/3/21), I took my temperature again at 6:00 am. It was 101.1. I still had a headache, body aches and fatigue. I took more Tylenol and my temperature was down to 100.8 within an hour. Had a temperature most of the day ranging from 99.5 to 100.0. My normal temperature is usually 97.9. Still very tired. On Thursday March 4th, feeling better. Still a little tired. Temperature is 98.3.
66 2021-03-03 headache Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a ... Read more
Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9810, expiry: unknown), via an unspecified route of administration in the left deltoid on 01Feb2021 14:15 at a single dose for covid-19 immunization at a Physician office. Medical history included asthma, irritable bowel syndrome, pneumonia and borderline high cholesterol. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had her first COVID-19 vaccine on 01Feb2021 and second one is due on 22Feb2021. On 03Feb2021, the patient had a headache, but didn't think too much because it is a side effect. The headache lasted all through the weekend. Visual disturbances began 04Feb2021. She called her doctor on Monday and was seen by her doctor on Tuesday, 09Feb2021. The patient was referred to the eye center. Her headache was getting a little better. On 10Feb2021, the patient was seen at an institution, her retina and macula looked good, so she was referred to the ED. The patient was told she probably had a stroke. The patient was admitted to the hospital for an ischemic stroke. By looking at the MRI, the onset of the ischemic stroke would have been five to seven days prior, placing the onset on Wednesday, 03Feb2021, which was also the onset of her headache. There is no definitive cause of her ischemic stroke. The patient currently has an arrhythmia monitor on. MRI/MRA showed her vessels looked good. MRI showed evidence of the ischemic stroke. The patient has neurologists since being admitted to the hospital. It was thought that the headache was just because of the COVID-19 Vaccine. Causality was unknown, it was stated that they haven't found anything else as a cause. The patient's doctor stated she was borderline for high cholesterol. She was not hypertensive, but supposedly is now. The patient also had echocardiogram, EKG, manual neuro checks, and blood work but does not have the results. The outcome of the events was unknown. The has trouble reading now since the stroke.; Sender's Comments: Based on available information, the reported events are assessed as unrelated to the vaccine BNT162B2 and can be explained as intercurrent or underlying medical conditions in this elderly patient with excessive weight (BMI=29) and underlying elevated cholesterol. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-03-03 headache Patient states 30 minutes after vaccine felt dizzy and headache when standing up, no improvement wit... Read more
Patient states 30 minutes after vaccine felt dizzy and headache when standing up, no improvement with sitting down. Patient alert, denies shortness of breath, or wheezing, but still lightheaded even with monitoring and fluids, so taken to ER
66 2021-03-03 headache Severe Headache, body aches. Treated with Tylenol, rest
66 2021-03-03 fever bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt h... Read more
bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt hot; her arm was hurting; water bubble appear on my arm with fever; fever; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EN6200), via an unspecified route of administration on 16Feb2021 at 09:15 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient was not tested for COVID-19 post vaccination. On 16Feb2021 at 22:00 the patient experienced bled at the injection site; arm is bruised, states there are little fever blisters on the arm, the arm was hurting and the arm felt hot (clarified the whole arm) on 16Feb2021; and water bubble appeared on the arm with fever "later on" on an unknown date in Feb2021. The patient was treated for the bled at injection site, arm felt hot and pain in arm which included cold ice pack and ibuprofen. The events did not require a physician visit or hospitalization. The clinical outcome of the event bled at injection site was recovered on 16Feb2021, the bruising and fever blisters at injection site was recovering, feeling hot and pain in arm was not recovered, water bubble and fever was unknown.
66 2021-03-03 headache headache; This is a spontaneous report from a contactable consumer (patient). This 66-year-old femal... Read more
headache; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female consumer received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 26Jan2021 for Covid-19 immunization. Medical history included eczema and lowered the immune system. Concomitant drug included dupilumab (DUPIXENT) for eczema for 1.5 years (as of 02Feb2021) which she gives herself a shot in the stomach every 2 weeks. She stated dupilumab affects the immune system and lowers the immune system. She was previously unaware of this and took the first dose of the Pfizer Covid 19 vaccine and only had a headache as a side effect. She took the dupixent either the day before, day of, or the day after the first dose of the vaccine, so the 25Jan2021, 26Jan2021, 27Jan2021, she had it on the 26Jan2021, and wondering if this impact the efficacy of the first dose. She was scheduled to take dupilumab on 09Feb2021 and second dose of the vaccine on 16Feb2021. Patient had no kind of bad interactions, she had a headache which was her only symptom. Outcome of the event was unknown. Information on the Lot/Batch number has been requested.
66 2021-03-04 lethargy, chills, headache Chills, headache, stiff neck, lethergy
66 2021-03-04 body temperature increased, headache Headache, body aches and temp 99.7
66 2021-03-04 chills, headache Headache, chills, body aches, slight intermittent nausea. Alternated Motrin and Tylenol Q3 hours. Be... Read more
Headache, chills, body aches, slight intermittent nausea. Alternated Motrin and Tylenol Q3 hours. Began medication at 1145am . Improving as day progresses. ( 2 doses Motrin, 1 dose Tylenol) Currently slight headache and body aches, but much improved.
66 2021-03-04 fatigue, chills I got very dizzy at the time of injection and the room was spinning, I sat for 30 minutes and they w... Read more
I got very dizzy at the time of injection and the room was spinning, I sat for 30 minutes and they watched me and let me go after. I immediately begin to feel very tired and couldn't think, my neck began to hurt and feel stiff and started having chills and still having chills.
66 2021-03-07 malaise Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain w... Read more
Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain why she didn't feel well. She woke up feeling well and then quickly became disoriented and vomited. She was then unable to walk or communicate appropriately. Emergency services was called and she was transported to Emergency room. She was diagnosed with a posterior brain CVA and was treated with tpa and now remains hospitalized in the ICU with expressive aphasia and vision loss.
66 2021-03-09 headache, fatigue, malaise Fatigue; body aches; headache; general malaise; This is a spontaneous report from a consumer (patien... Read more
Fatigue; body aches; headache; general malaise; This is a spontaneous report from a consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (lot/batch number and expiration date were unknown) via an unspecified route of administration at left arm on 05Feb2021 13:30 at single dose for COVID-19 immunisation. Medical history included idiopathic hypertrophic subaortic stenosis (IHSS). Unspecified concomitant medication used in two weeks. There was no known allergies. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not pregnant. The patient had fatigue, body aches, headache and general malaise on 06Feb2021 at 08:00 a.m. Patient did not receive any treatment for events. She did not have COVID tested post vaccination. The outcome of events was recovering. Information on batch number has been requested.
66 2021-03-09 chills having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the... Read more
having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the night; body aches/achy; chills (no fever); nausea; got the sore arm; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318 (not clarified further)), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation and loratadine (CLARITIN), via an unspecified route of administration from 03Feb2021 at an unspecified dose for unspecified indication. Medical history included ongoing High cholesterol and Sleep disorder, both from unknown date. Concomitant medication included alprazolam (XANAX), calcium (CALCIUM), cyanocobalamin (VITAMIN B12), Multivitamin, taking a statin to prevent high cholesterol and L-methylfolate, stated it is like a folic acid drug. Because the patient really can't take anti-depressant she reacted to them all (Unspecified Medications), so that worked for her and helped her to keep up her spirit. The patient reported her side effects. She didn't want to interfere with anything but she was having lots of Gastrointestinal issues which were inconvenient. She was up in the middle of the night, happened not within 48 hour after the first dose of the Pfizer vaccine but around 60 hours after the vaccine, early this morning (06Feb2021) like around 2 am. The patient was having a reaction after the vaccine but they seemed to be like delayed reactions. Not anything with breathing, she had gastrointestinal stuff going on. The patient had chills, no fever, body aches and she was really going to the bathroom nonstop in the night. It seemed to have been like 2 days after she got the shot like they were worst yesterday (05Feb2021). And she experienced achy, chills, nausea, diarrhea and sore arm in Feb2021. She would like to take TYLENOL and IMODIUM and she didn't know what she could take because she didn't want anything to interfere with that as she had been reading a lot. The patient wanted information on IMODIUM to prevent diarrhea, TYLENOL for body aches, chills (no fever), and FLONASE for sinus. The patient did not receive any treatment for the events. The patient actually didn't even take, that morning that day when she was getting the shot, she called the pharmacist to see if she could spray her nose with the FLONASE for sinus and he told her that he didn't think it was a good idea and that maybe she should just take CLARITIN, so she did. But she took CLARITIN that morning (03Feb2021) and she was hoping that didn't interfere. She was just nervous about it as she didn't want that to interfere with the work that it was. The patient was still suffering, less, like she didn't have the diarrhea anymore. She still had a little achy. She did get the sore arm but only for one day, so it wasn't so bad. The action taken in response to the events for loratadine was unknown. The outcome of event diarrhea and got the sore arm was recovered on an unspecified date in Feb2021, of event achy was recovering, of other events was unknown. Information on the lot/batch number has been requested.
66 2021-03-09 headache, chills injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection si... Read more
injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection site pain, redness, and swelling; headache; chills; muscle and joint pain; muscle and joint pain; nausea; dizziness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via an unspecified route of administration in the left arm on 06Feb2021 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included slightly elevated blood pressure, not taking medication, and COVID prior to vaccination, on an unspecified date. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) and vitamin supplements. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Feb2021 16:00, the patient experienced injection site pain, redness, and swelling; headache, chills, muscle and joint pain, nausea, dizziness and weakness. No treatment was received for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
66 2021-03-10 headache Caller says the the pt started having really bad headache the day after taking the vax that lasted a... Read more
Caller says the the pt started having really bad headache the day after taking the vax that lasted about a week and half. She had 4 hours of amnesia. Pts husband took her to Hospital ER where she had a brain scan and was diagnosed w/ TGA and then admitted.
66 2021-03-14 nasal congestion, fever, headache Swollen painful lymph node in armpit and another between armpit and elbow; Swollen painful lymph nod... Read more
Swollen painful lymph node in armpit and another between armpit and elbow; Swollen painful lymph node in armpit and another between armpit and elbow; Fever of 100 degrees; Deep muscle pain in small areas that lasted few seconds, moved from one part on body to another; Headaches; Congestion; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9269) via an unspecified route of administration on 05Feb2021 at 13:30 (at the age of 66-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism and pre-hypertensive. The patient had COVID-19 prior to the vaccine on an unknown date. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included HCTZ and levothyroxine sodium (LEVOTHYROXIN) from unknown dates for unspecified indications. The patient previously took penicillin from an unknown date for an unknown indication and experienced allergy. On 05Feb2021 at 14:30 the patient experienced swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcomes of swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
66 2021-03-14 fever, body temperature increased, headache full blown auto immune flare/ a great big flare; mild headache; temperature of 102 degrees; This is ... Read more
full blown auto immune flare/ a great big flare; mild headache; temperature of 102 degrees; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration on 21Jan2021 (at age of 66 years old) at single dose for COVID-19 immunization. The patient's medical history included autoimmune diseases (She had a host of autoimmune diseases. Her body was one big inflammatory responses). Concomitant medications were not reported. The had reactions and was concerned about getting the second dose. She had a host of autoimmune diseases. Her body was one big inflammatory responses. Her doctor figured she would feel it. She started with a mild headache. On the 7th day she was slammed. Her doctor said it was pretty unusual after this long. She had a temperature of 102 degrees. It was like having a full blown auto immune flare that lasted for two days and went away. She was left with a great big flare. She was not able to provide full details as she had an appointment that she had to pay out of pocket for. She was not concerned about the reaction that takes a day or 2 to get over. She was having hell from her usual responses. She was afraid in six months she would be crippled. The outcome of events was unknown. She was due to receive the second dose on Tuesday.
66 2021-03-15 fever fever; I have dystonia (OMD)/ my symptoms have been aggravated the last few days; I have dystonia (O... Read more
fever; I have dystonia (OMD)/ my symptoms have been aggravated the last few days; I have dystonia (OMD)/ my symptoms have been aggravated the last few days; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Feb2021 16:45 (batch/lot number: EN 6200) as a single dose for COVID-19 immunisation. Medical history included dystonia (OMD), multi nodular goiter, fatty liver, and uterine fibroids. The patient was not pregnant at the time of vaccination. Concomitant medications included omeprazole, colecalciferol (VITAMIN D), and tonic lemonade with thc; taken for unspecified indications, start and stop dates were not reported. The patient previously took amoxicillin clavulanate and experienced allergies. On 27Feb2021 16:00, the patient has just developed a fever and she really doesn't get fevers. She was normally low at 96.7 and today she was 98.7. She has dystonia (OMD) and her support group was reporting Covid vaccines were making dystonia symptoms worse. Her symptoms have been aggravated the last few days. She had no dystonia reaction until the last 2 days and symptoms might not have anything to do with the vaccine. She was just reporting this because her support group was saying they were worse since the vaccine. She was concerned she has a fever since she never gets them. She hasn't been out of the house since the vaccination. Facility type for the vaccine was a school or student health clinic. No other vaccine in four weeks. No Covid prior to vaccination and was not Covid tested post vaccination. There was no treatment received for the events. The outcome of the events was unknown.
66 2021-03-15 nasal congestion muscle and nerve on both side of her face and the area along the back of both ears on the back head ... Read more
muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; From thumb finger till middle figure of both hands are numb especially after getting up daily.; The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention); Both gums are very soreness and distention; Both gums are very soreness and distention; Stuffy nose; night sweats; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 66-year-old, on 20Feb2021, single dose for COVID-19 immunization. Relevant medical history included diabetes. The patient had no known allergies. Patient is not pregnant. Concomitant medications included metformin, thiamine hydrochloride (VITAMIN B1 [THIAMINE HYDROCHLORIDE]) taken for covid-19 immunisation; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (left arm), at the age of 66-year-old, on 23Jan2021, single dose for COVID-19 immunization and experienced muscle and nerve on both side of face (especial jawline area) are uncomfortable. On 21Feb2021 at 07:00 am, her muscle and nerve on both side of her face (especial jawline area, marionette line area, nasolabial folds, both temples and lower eyelid region) and the area along the back of both ears on the back head are very uncomfortable. From thumb finger till middle figure of both hands are numb especially after getting up daily. The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention). Both gums are very soreness and distention. Stuffy nose and night sweats in the whole body happen a few times daily after the 2nd dose as well. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
66 2021-03-16 fever, chills The evening after patient received vaccine, she started to develop low grade fever and urticarial ra... Read more
The evening after patient received vaccine, she started to develop low grade fever and urticarial rash at the vaccine site. The urticaria improved the following day, as did the fevers. Then 3/5, the fevers started again, several times per day, as high as 102 at home. In association with the fever she has had some mild nausea, x1 non-bloody emesis last night, as well as rigors/night sweats. She went to urgent care and eventually was admitted to the hospital for the following 9 days. During this admission, she continued to have fevers intermittently as high as ~103. She also developed more generalized urticarial rash (worst on trunk), and lab abnormalities including low platelets and elevated liver function tests. She had extensive testing, ultimately determined likely vaccine reaction, started on prednisone 40 daily and improved for discharge to home on 3/17 without fevers x48 hours and with improving labs.
66 2021-03-16 sweating, nasopharyngitis tested positive for Strep yesterday and is on a Z-pak (today is day two for the medicine)/tested pos... Read more
tested positive for Strep yesterday and is on a Z-pak (today is day two for the medicine)/tested positive for Strep throat; dizzy with sweats; dizzy with sweats; head cold; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248; Expiration Date: 01Apr2021), via an unspecified route of administration on the right arm on 23Jan2021 at single dose for COVID-19 immunisation . Medical history included patient required acid reducer. Concomitant medication included omeprazole taken as acid reducer.The patient stated that she tested positive for Strep yesterday and is on a Z-pak (today is day two for the medicine). She asked if it is okay if she still gets her vaccine tomorrow. She tested negative for Covid on Feb2021. States she is being treated with Azithromycin, a z-pack, 250mg two tablets to start then one a day. States she just felt like she had a head cold, got up yesterday and was dizzy with sweats and it went away in about 15 minutes on 11Feb2021. The outcome of head cold and dizzy with sweats was recovered on 11Feb2021 and other event was not recovered.
66 2021-03-17 headache Bloating; Constipation; Gas; Headache; This is a spontaneous report from a contactable consumer repo... Read more
Bloating; Constipation; Gas; Headache; This is a spontaneous report from a contactable consumer reporting for himself and his wife. This consumer reported similar events for two patients. This is the second of two reports. A 66-year-old female patient (reporter's wife) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8982), intramuscular on 26Jan2021 at a single dose on the right arm for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. The patient did not have prior vaccinations within 4 weeks of the COVID vaccine. The reporter called for himself and his wife. He reported that they looked at the at the symptoms on the vaccine fact sheet and they did not have any of those symptoms. They received the first dose of the vaccine on 26Jan2021. The first couple of days they had a little bit of a headache starting on 27Jan2021. The third day, 29Jan2021, they started having constipation and bloating which is not normal for them. They are having a lot of gas and are very bloated. The reporter and patient was asking if anyone else has reported this since it is unusual for them. The patient then stated that she had just a very mild headache. She has been able to go to the bathroom a little bit. Usually she is going to the bathroom a lot. The patient stated that the gas and bloating is unreal. All she had last night was chicken broth and a piece of toast for dinner. She took Tylenol for the headache. She is not taking anything for constipation. She is drinking caffeinated coffee which she never drinks or she would be going to the bathroom all day. She just wishes she could fart. The outcome of headache was recovered on 29Jan2021. The outcome of bloating, constipation and gas was not recovered.
66 2021-03-17 malaise On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had ... Read more
On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had parkinsons disease. The heaviest shaking was of the right arm and hand which was where the vaccine was administered. Made my way to bedroom on my walker to tell hubby I was not feeling well, Took blood pressure which was elevated and my heart felt like it was beating out my chest, Bllod pressure was elevated and so was pulse. Shaking continued and breathing was shallow, Waited 10 minutes and retook vitals, BP and pulse up more, Called 911, Paramedics came and monitored my vitals several times which after 20 minutes started declining, Could not say conclusively if was vaccine related. Elected due to Covid not to be transported to hospital and signed off on declination, Was told by paramedics to call 911 again if symptoms reoccurred and go to hospital, In successive days I still continue to have pin-prick feelings and numbness in my right fingers, More difficult to walk than usual,
66 2021-03-18 malaise RLQ pain (without radiation), nausea, malaise and some constipation. Patient reported pain to be pre... Read more
RLQ pain (without radiation), nausea, malaise and some constipation. Patient reported pain to be pressure, sharp and shooting, and 7/10 in intensity. Acute appendicitis and localized peritonitis. Patient underwent laparoscopic appendectomy.
66 2021-03-18 fatigue, chills, headache chills; moderate headache; fatigue; This is a spontaneous report from a contactable nurse, the patie... Read more
chills; moderate headache; fatigue; This is a spontaneous report from a contactable nurse, the patient. A 66-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the left arm on 08Feb2021 at 15:45 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included gluten allergies and celiac. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were none. The patient did not have any other vaccines within 4 weeks of the vaccination. On 11Feb2021 at 23:30, the patient experienced chills, moderate headache and fatigue. The events started to resolve on 13Feb2021, but the patient continued to have a very mild intermittent headache. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of chills and fatigue resolved on Feb2021, while moderate headache resolved with sequel on Feb2021. Information on the lot/batch number has been requested
66 2021-03-20 chills, headache N/v, confusion, headache, chills, weakness
66 2021-03-22 fever, influenza like illness, headache Got flu like systems the following day and each day felt weaker with headache and ear and neck pain ... Read more
Got flu like systems the following day and each day felt weaker with headache and ear and neck pain thought flu ignored. Then felt worse went to urgent care tested negative for corona virus. Seen by dr on site.12/12/21. Double ear infection. Home with antibiotics, got worse. Face extreme pain went to ER at hospital due to left side face dropping and speech slurring was diagnosed with double ear infection and Bell Palsy on 3/14/2021.
66 2021-03-24 headache Four days of headaches starting 3/12/2021 (onset 7 days following vaccination) following by rapid on... Read more
Four days of headaches starting 3/12/2021 (onset 7 days following vaccination) following by rapid onset (~6 hr) nausea, vomiting, and encephalopathy with cortical blindness and altered level of consciousness on 3/15/2021. Found to have diffuse white matter hyperintensities on MRI brain. No spinal cord involvement. CSF analysis with lymphocytic pleocytosis. Negative infectious workup. Started on high dose steroids and plasmapheresis for presumed autoimmune encephalitis. Slow improvement in symptoms for the first 10 days following initiation of steroids (present day).
66 2021-03-24 fatigue, throat pain, headache Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and s... Read more
Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and swollen; raised red itchy rash on neck, chest and abdomen; swollen lymph glands in throat; diarrhea; sore throat; site soreness; achy joints; headache; nausea; fatigue; Racing heartbeat; throat felt lujeir was closing; tongue felt tingly and swollen; This is a spontaneous report from a contactable healthcare professional (the patient). A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205), via an unknown route of administration in the left arm on 06Mar2021 at 16:30 (at the age of 66-years-old) as a single dose for Covid-19 immunization. Medical history was included celiac sprue, Crohns, chronic pancreatitis, psoriasis, osteoporosis, and ulcerative colitis, all from an unknown date and unknown if ongoing. The patient was allergic to penicillin and codeine. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269) on 13Feb2021 at 11:30 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported however it was reported the patient had other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 16:30, within 5 minutes of injection, the patient experienced Racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands. The patient also experienced the typical side effects of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat, and raised red itchy rash on neck, chest and abdomen. Treatment of Benadryl was given for the events as recommended by paramedic which was still being taken on day 4. The clinical outcome of the events racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands was recovered on 06Mar2021 (reported as 'last about 10 minutes'); outcome of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat and raised red itchy rash on neck, chest and abdomen was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-03-24 fatigue Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable co... Read more
Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable consumer (patient). A 66 years old female patient (weight: 107.95 kg, height: 165 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 04Mar2021, at 16:50, for COVID-19 immunisation. Relevant medical history included atrial fibrillation from Jan2016 and ongoing and cardiac ablation on an unspecified date, in Feb2020 (she had her 2nd ablation in Feb2020, since then she has had intermittent episodes of atrial fibrillation. She stated prior to the second vaccine she had been in normal sinus rhythm for 8 days). Patient stated that she had a sister who had an arrhythmia problem. The patient previously, on 10Feb2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) in the left arm, at single dose, for COVID-19 immunisation. Patient stated that she had no problem with first dose. The patient received concomitant medications (unspecified). On 04Mar2021, at 21:00, the patient experienced atrial fibrillation and on 04Mar2021 she was tired. On 05Mar2021, she developed pain in the left arm. The patient recovered from pain in arm on 05Mar2021, from tiredness on 07Mar2021, while did not recover from atrial fibrillation. The information on the lot number has been requested.
66 2021-03-26 headache, malaise, fever high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and se... Read more
high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and severe pain and weakness.
66 2021-03-28 headache, fatigue, sweating, chills, lethargy, productive cough feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous... Read more
feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous out of her chest; feels so tired; no appetite, food doesn't taste right; sweating and chills; sweating and chills; feels weak; extremely sick; joints and arms hurt; joints and arms hurt; doesn't feel like walking around/Lethargic; can't hardly even talk to people; Headache; feels like she has been poisoned; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration on Left arm on 09Mar2021 between 15:00 and 16:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient states she took that shot on Tuesday and she is still sick and still doesn't feel good. States that she feels better, but she is coughing and spitting up white mucous started on 10Mar2021. She feels like she has been poisoned in Mar2021. States that she is coughing stuff up out of her chest. States that she took this on Tuesday (09Mar2021) and still feels drugged and tired. She states that it made her extremely sick and she is not taking the second shot. She states she took the shot Tuesday and didn't get sick until three to four hours after, she was down feeling so bad, like an ailment or disease. She states she feels like we gave her the Covid. She states she won't even go to the hospital because can't trust anyone. States that her joints and arms hurt and can't hardly even talk to people on 09Mar2021. States she has fluid in her chest that she didn't have before on 10Mar2021. States that this is the first day she has gotten out of bed. States that she is not taking the second shot. States that she had to sit for fifteen minutes after her shot and she felt fine. Clarified that she couldn't eat, she had sweating and chills for two to three days and she couldn't even get out of bed on 19Mar2021. States she feels better but still feels weak and lethargic on 09Mar2021. States it has improved since yesterday. States that her food doesn't taste right but no appetite on 09Mar2021. States the sweating and chills ended 11Mar2021. She states that she had a headache and it started on 09Mar2021 and it went away 12Mar2021 with treatment of Aspirin. Not sure if she is going to recover. Prior to vaccination, was the patient was not diagnosed with COVID-19. The outcome of events Poisoning; feels drugged, extremely sick was unknown, for Coughing and spitting up white mucous out of her chest was not resolved, for headache it was resolved on 12Mar2021, for feels so tired; no appetite, food doesn't taste right; joints and arms hurt; doesn't feel like walking around; can't hardly even talk to people; feels weak; Lethargic was resolving, for fluid in her chest that she didn't have before was not resolved, for sweating and chills it was resolved on 11Mar2021. Follow-up attempts are completed. No further information is expected.
66 2021-03-28 chills, fatigue peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination;... Read more
peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
66 2021-03-30 chills I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fev... Read more
I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fever. On Saturday I was better but still weak and that is when cellulitis started in my left leg. On March 7, 2021, I was seen in the ER. I was given a shot and antibiotics and told to return if not better. So on Monday, March 8, I returned to ER and then was admitted to the hospital. I was allowed to go home on Saturday, March 13. Since then I had two sores to develop on my left leg. I had to have wound surgery on them on March 25. I am a lot better but still not completely well.
66 2021-03-30 sweating drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart... Read more
drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart beat; no appetite; exacerbation of existing neuropathy; Palpitations; being lightheaded; sweating; burning mouth syndrome; burning mouth syndrome; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; Some of my reactions look like an allergic reaction; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 66-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3302, expiry date not reported) via an unspecified route of administration, administered in left arm on 11Mar2021 14:00 at a single dose for COVID-19 immunisation. Medical history included neuropathy from 2006 and ongoing, since she had chemotherapy in 2006 for breast cancer in 2006 and burning mouth syndrome. The patient had no covid prior vaccination. The patient had no known allergies. The patient had other medications in two weeks which included unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient previously took doxycycline from 2010 to an unknown date for Lyme's diseaseand experienced burning mouth syndrome. On 11Mar2021 at 02:00 PM, patient had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. These symptoms still continue. Patient stated that people were talking about the second dose being worse. Patient stated that some of the reactions in Mar2021 look like an allergic reaction. They (HCP) only have cautioned the patient about difficulty breathing in Mar2021. They were saying there wasn't anything they can do for it. Patient asked how long the side effects will last and how to go about changing the appointment. If they are going to continue, patient was very concerned about following up with the second shot and asked if they can have that second shot be postponed until patient was not experiencing these side effects to the effect that she was. She completed the self-reporting on Monday (15Mar2021), but because her side effects were not going away she wanted to reach out to someone. She has reached out to her practitioner and had an appointment yesterday. Doctors didn't really know because it was all very new. She had the first vaccination shot on 11Mar2021, almost a week ago. In the 15 minutes that she waited afterwards she definitely experienced palpitations and a feeling of lightheadedness. She has an underlying condition of burning and pain called neuropathy. She has had neuropathy since she had chemotherapy in 2006 for breast cancer. This exacerbated that. She had been very concerned about that prior. Everyone said and the CDC recommends even with neuropathy to go ahead with the vaccine. It also triggered another underlying condition. She had a reaction to a course of Doxycycline in 2010 for Lyme's disease that caused burning mouth syndrome. Both of these things were really acute now, the neuropathy and burning mouth syndrome. Monday (15Mar2021) was a particularly bad day because the symptoms of an allergy which were swelling of the face and throat, fast heart beat, and dizziness were with the burning mouth syndrome. She didn't have difficulty breathing. It was the nerve endings of the tongue that go all the way to the back of her throat and gave the sensation of the whole mouth being involved. Monday was difficult. It was 8 hours of an acute episode then it eased off a little that evening. She had no appetite on Monday and barely ate anything. Yesterday was ok and much better although she was being triggered by environmental thing such as food and toothpaste. Things she normally uses were setting it off. She had an acute reaction this morning to a protein shake she has had every day for 14 years. The reaction this morning, 17Mar2021, was a drop in blood pressure and palpitations. It passed. She has been documenting this and made her provider aware of what she was experiencing. She was participating in the V-Safe through the CDC that checks up on her everyday and asks about symptoms. She didn't know if she was supposed to report this to the vaccine adverse event system or not. Obviously, she didn't want to get COVID. She was struggling with the recommendation to get second shot because she was extremely concerned. She wanted to know how long will the side effects will last and if she can postpone getting the second shot until she gets reasonably well. No practitioner can recommend whether to do it or not to do it. She reported this information online to Pfizer on 15Mar2021. She provided the lot number when she reported it online. The patient was not tested for COVID post vaccination. No treatments received from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The patient recovered with lasting effects from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The outcome of the other reported events was unknown.
66 2021-04-06 headache, fatigue After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nau... Read more
After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer. Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face. After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included: sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days.
66 2021-04-06 fatigue, headache After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nau... Read more
After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer. Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face. After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included: sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days. Adverse event described in on Continuation Page.
66 2021-04-10 fatigue Platelets dropped to 3000. Went to ER. Given 2 units of platelets immediately and omitted for 9 day... Read more
Platelets dropped to 3000. Went to ER. Given 2 units of platelets immediately and omitted for 9 days of treatments. Received a call from my doctor urging me to get to the ER immediately after receiving my quarterly blood work. Other than feeling somewhat fatigue I presented no symptoms. I was a walking time bond and in very serious danger of a bleed out. This was 9 days after my 2nd injection.
66 2021-04-11 chills, fever, malaise My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and dia... Read more
My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot.
66 2021-04-12 fever four days after second shot, severe stomach pain, fevers, trouble urinating, chest pain, . turned in... Read more
four days after second shot, severe stomach pain, fevers, trouble urinating, chest pain, . turned into kidney infection, blood infection and having AFIB, need for pace paker.
66 2021-04-17 headache seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is ... Read more
seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is a spontaneous report received from a contactable healthcare professional (patient herself). A 66 -year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EN6208; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunisation. She provided a brief history from 2017. She was walking her dog and she fell and suffered a concussion, she had a seizure, then she developed bipolar disorder. She's been taking sodium valproate (DEPAKOTE) for her seizures since 2017. She reports she's very active. She's not an old lady. She can run circles around some 22 year old's. In September of 2017, she had a concussion and had seizures. She's been on sodium valproate (DEPAKOTE) since that time. She's not mentally ill, the concussion she got in 2017 caused her brain to turn bipolar. It's hard for people to understand that. Sodium valproate (DEPAKOTE) was 500mg. She takes 1 tablet in the morning and 2 tablets at night because it can make you sleepy. She reports she was recently hospitalized in Feb2021 for atrial fibrillation with rapid ventricular rate (RVR). Her heartrate was 181 beats per minute, her blood pressure was dropping, she tested positive for rhinovirus and the doctor thinks the atrial fibrillation with RVR was caused from the rhinovirus. She was allergic to bee venom and carries an EPI PEN. Medical history also included ongoing high blood pressure from an unspecified date (controlled with medication). Concomitant medications included ongoing metoprolol tartrate (LOPRESSOR) taken for blood pressure; ongoing lisinopril; ongoing valproate semisodium (DEPAKOTE) taken for seizure from 2017; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for blood pressure; paracetamol (TYLENOL) from an unspecified date in 2021. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021). The patient did not receive any recent vaccines for any other conditions or any recent vaccines for any other conditions prior to the event being reported; or any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient reported that with the second Covid 19 vaccine she had two seizures on 27Mar2021. The seizures were back to back. The seizures resolved within 2 minutes. She had fatigue from an unspecified date, sore muscles and a wrap around headache on 26Mar2021. The wrap around headache felt like she was going to have a stroke even though her blood pressure was fine. She monitored her blood pressure at her home. She feels it's weird that they publish that the second Covid 19 vaccine is going to be worse. She thought she'd have muscle soreness and fatigue but not seizures. She looked it up and the wrap around headache and seizure are the rarest things that can happen after receiving the Covid 19 vaccine. She stayed in bed from Friday afternoon after she received the second Covid 19 vaccine on 26Mar2021 and started to feel better Sunday afternoon, 28Mar2021. Her blood pressure and pulse were both fine with her wrap around headache. She had fatigue with both Covid 19 vaccines. She also developed hives, which she still has. She has a rash from her head to her toes. It looked like she rolled around in an ant bed. The hives were clearing up. She was using an anti-itch cream. The hives and the rash started midday on Saturday, 27Mar2021. She only has around 5 hives now on her chest. She hasn't taken Benadryl. She doesn't like to take it. Her doctor didn't want her to open the hives and cause impetigo. She never had any soreness in her arm. She doesn't think the headache was serious because she had a blood pressure cuff at home. She just knew the hives and the rash were a reaction to the Covid 19 vaccine. She didn't go to the hospital for her seizures. She was not seen in the Emergency Department, hospitalized, or admitted to an Intensive Care Unit. She tries to do holistic medicines and treatments. She doesn't run to the hospital every time something happens. She tries to stay out of the hospital. She's fine now and she loves Pfizer. If she can get a medicine she needs that Pfizer makes she tries to get it. She tries to see every side of things. Outcome of seizures was recovered on 27Mar2021 and sore muscles was recovered on 28Mar2021; of remaining events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and seizure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
66 2021-04-23 headache, chills, fever Fever of 100.8; chills; headache; This is a spontaneous report from a contactable consumer (patient ... Read more
Fever of 100.8; chills; headache; This is a spontaneous report from a contactable consumer (patient sister). A 66-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) second dose via unspecified route of administration, administered in left arm on 02Feb2021 13:30 and first dose via unspecified route of administration, administered in left arm on 12Jan2021 3:00 PM as single dose for COVID-19 immunization. The patient medical history included prior breast cancer. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Patient does not for underwent lab test and procedures which included COVID-19 test for post vaccination. On 10Feb2021 03:00 PM patient experienced Fever of 100.8, chills, headache. This report was for reporter's sister who received the second dose of the Pfizer COVID vaccine. The reporter reported it on the day she told me about it also reported that within 24 hours of learning of her reaction as required under our reporting policy. The outcome of the events was recovered. Follow-up (19-Feb2021): This is a follow-up spontaneous report in response to mail trail sent regarding confirmation of reporter and awareness date. This report included the awareness date. Information about lot and batch number was requested.
66 2021-04-23 fever Lost her sense of taste and smell; Lost her sense of taste and smell; Tested positive for Covid afte... Read more
Lost her sense of taste and smell; Lost her sense of taste and smell; Tested positive for Covid after receiving first dose of vaccine; Tested positive for Covid after receiving first dose of vaccine; Fever; body aches; Diarrhea; stomach symptoms abdominal discomfort; This is an initial spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNTl62B2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL8982; Expiration Date: 20May2021) first dose via an unspecified route of administration and administered in right arm on 23Jan2021 14:00 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Past drug included When she gets the flu shot, she gets a low grade fever and body aches for about 1 night. No Lot/NDC/Expiry for any of those Flu shots. States that this happens every year. On 08Feb2021 patient underwent lab test and procedures which included COVID-19 test and tested positive for first dose vaccine. Patient about the Covid-19 Vaccine. States that she doesn't know if there is something for self reporting, but her mom and her husband both got the vaccine, then 16 days later got symptoms of Covid, then on the 17th day, tested positive for Covid; and this was after the first dose of the vaccine. States that her mom, is on day 12 of Covid and still having symptoms. States that she was tested for Covid-19 on 08Feb2021, and it resulted on 10Feb2021 as positive. She started having symptoms such as body aches on 07Feb2021 to 08Feb2021, and the fever started 08Feb2021 to ongojng. She still had a fever yesterday. Caller states that the fever would disappear for a day or two, then come back, and this has been going on for the last 10 days. She also lost her sense of taste and smell about a week ago, and got it back about 1.5 days ago. Also had stomach symptoms as well, had diarrhea on 06Feb2021 and 17Feb2021, resolved that day 17Feb2021. The outcome of the events like Drug ineffective and SARS-CoV-2 test positive were unknown, pain, Ansomia, Ageusia and Diarrhoea was recovered and fever was not recovered.
66 2021-04-23 headache, fever fever of 101.3; full body muscle pain; headache; vomiting; This is a spontaneous report from a conta... Read more
fever of 101.3; full body muscle pain; headache; vomiting; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 9809; Expiration Date: unknown) via an unspecified route of administration, in Arm Right on 09Feb2021 08:15 for COVID-19 immunization.The patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 3247; Expiration Date: unknown), via an unspecified route of administration, in Arm Right on 19Jan2021 08:15 for COVID-19 immunization. The patient previously took Levaquin and bnt162b2.Medical history included neuropathy peripheral, rosacea, drug hypersensitivity to levaquin. Concomitant medications included vitamins (MULTIPLE VITAMIN), ciclosporin (RESTASIS), calcium and omega 3 taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 22:00, the patient experienced fever of 101.3, full body muscle pain, headache, vomiting. The patient underwent lab tests and procedures which included body temperature: fever of 101.3 on 09Feb2021. The outcome of the event was recovered.
66 2021-04-24 nasal congestion, runny nose, sneezing Allergic reaction/Reaction or allergies; Stuffy head; nose began to run and began to sneeze; sneeze;... Read more
Allergic reaction/Reaction or allergies; Stuffy head; nose began to run and began to sneeze; sneeze; Nasal stuffiness; Seasonal allergies; Rheumatoid arthritis; Joint and muscle pain that are worse; Joint and muscle pain that are worse; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization; and treprostinil sodium (TYVASO), via resp inhalation from Feb2021 to an unspecified date, at 18-54mug (3-9 breaths), 4x/day for secondary pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension, ongoing arthralgia, ongoing myalgia, seasonal allergy, and hypertension from an unknown date. Concomitant medications included sildenafil citrate taken for an unspecified indication; and amlodipine besilate taken for hypertension. The patient previously took meloxicam for joint pain. On an unspecified date in 2021, the patient experienced joint and muscle pain that are worse, rheumatoid arthritis and seasonal allergies. The patient had joint and muscle pain for a while, but was worse since starting treprostinil sodium. The event of rheumatoid arthritis was considered as medically significant. The patient had joint and muscle issues (arthralgia, myalgia, and rheumatoid arthritis) that could be debilitating, reported that they were getting better with the Nabumetone. On 29Mar2021, the patient had nasal stuffiness that started when she went on an outing. She felt like she was doing better this week than last week (at time of report). On 31Mar2021, the patient reported that she was having a reaction or allergies. She received her first COVID vaccine on 29Mar2021 and felt fine but woke up on Tuesday (30Mar2021) with stuffy head, nose began to run, and began to sneeze. The action taken in response to the events for treprostinil sodium was unknown. The outcome of the events arthralgia and myalgia was recovering, for rheumatoid arthritis was not recovered, and for other events was unknown. The reporter's causality for the event of myalgia and arthralgia with IH Tyvaso was considered to be possibly related. The reporter did not provide causality for the events of rheumatoid arthritis and seasonal allergy. Case Comment/Senders Comment: The company has assessed the serious adverse event of drug hypersensitivity and rheumatoid arthritis as not related to IH treprostinil and TD-300/A device. Drug hypersensitivity was likely due to administration of COVID vaccine. Rheumatoid arthritis was likely an underlying medical condition in this 66-year-old patient based on an implausible time to onset for the reported event. Information on the lot/batch number has been requested.
66 2021-04-24 fatigue Erythema multiforme; asthma attack/shortness of breath/cough; Rash started on legs on the 03Apr2021 ... Read more
Erythema multiforme; asthma attack/shortness of breath/cough; Rash started on legs on the 03Apr2021 late morning buy next day (04Apr2021) full body rash from shoulders to top of feet; extreme exhaustion; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER 8730), via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 as single dose for covid-19 immunisation. Medical history included heart disease, high blood pressure, asthma, drug hypersensitivity and wasp stings. Concomitant medication(s) included amlodipine; aspirin and atorvastatin. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 09:45 late morning, the patient experienced rash started on legs by next day (04Apr2021) full body rash from shoulders to top of feet. Later on 03Apr2021, extreme exhaustion and dry cough that went into shortness of breath and asthma attack. Visit to ER and later sent to dermatologist. Possible Erythema multiforme. As of 09Apr2021 still have rash and exhaustion and dry cough. It was unknown whether patient received any treatment. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
66 2021-04-26 headache, fatigue nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels li... Read more
nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Constipated; Doesn't sleep through the night; Headache lasted for days and days; No appetite, lost 6 pounds in a week; No appetite, lost 6 pounds in a week; Tired; Diarrhea; Nausea; felt like Dumping Syndrome; Stiff neck, like an iron claw; Anxiety reared up; Blacked out; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 17Mar2021 at 11:30 AM (at the age of 66 years old) (Lot Number: EN6205, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included ongoing anxiety (40 years or more), ongoing depression (46 years ago, at the age of 20), ongoing acid reflux (maybe 25 years), ongoing GERD (maybe 25 years), ongoing Barrett's esophagus (for 12 years), mild to moderate COPD since 2011, gastric bypass (a year and a half ago), and lost 120 pounds. Concomitant medications included bupropion for anxiety depression and omeprazole for acid reflux, both ongoing. The patient previously received flu and tetanus on unspecified dates for immunization and both experienced hard red welt on arm (welt was hard and lasted for 5-7 days). The patient reported no side effects for 12 hours, but a little soreness at injection site on 17Mar2021 at 20:00 (8:00 PM). Her arm wasn't heavy, but she had an awareness of the soreness. She has had life-long anxiety and depression. Several weeks ago (on 26Mar2021), her anxiety reared up, and it could have been due to a family situation. On the 9th day after the first shot, she was having a therapy appointment on the phone and talking about her anxiety, and she got a stiff neck, like an iron claw (26Mar2021 at 10:00 am). It lasted for a couple of 5 minutes and she laid down on the couch then on the floor. Her therapist said to call 911. Emergency medical technicians came to her house and they said all of her numbers looked good. She went to the hospital, and was in the emergency room for several hours, but she only remembers one hour of it. She also had diarrhea and nausea on 26Mar2021 at 11:30, and it felt like Dumping Syndrome, that one can have from a gastric bypass. She was only aware for one hour at that point and blacked out (on 26Mar2021). With regards to nausea, she mostly saw bile in the bag, all she had that day was a protein drink. She was back home and the next day, she did not remember how she got home. She hasn't had blackouts anymore but feels it may be from heightened anxiety. On 27Mar2021 at 09:00, she had no appetite, lost 6 pounds in a week, and was tired. She had headache lasted for days and days on 29Mar2021 at 09:00 AM. She is slowly improving but she still doesn't sleep through the night on 29Mar2021 at 16:00. It was like a feeling like she was resetting her surgery, like she didn't care about eating. The also experienced back pain, butt and legs hurt, feels like sciatica on 31Mar2021 at 16:00 and was constipated. She is using a stool softener and is back in her routine. She called her primary doctor and could not tell her what happened, and she went in a loop trying to get information and authorizations for her to make a determination of what had happened. Her doctor felt like she should have an MRI. Her heart and all of her numbers looked good, as the emergency medical technicians said. Her primary doctor recommended her to get the second shot. She had cancelled the second shot for this week, and she has rescheduled it for another date. She was afraid that she will black out again, after the next vaccine, and is not sure if that is how her anxiety manifested. The main reasons she is calling is that she had no concerns of side effects prior to the vaccine, and a couple of her neighbors said they had read about side effects of the vaccine, but she was not worried. When the patient started to read about side effects of the vaccine, she understood that on the 10th day, the vaccine starts to be in a person's system and that maybe is why she didn't have initial side effects, but then she had side effects several days later because the vaccine was in her body. By day 10, the vaccine is in effect in the body and she is nervous. Her second vaccine is scheduled on 26Apr2021. The patient would like to know if there is any information on people that have had a gastric bypass. The patient has no prior vaccinations within 4 weeks. The events resulted in emergency room visit (except nervous). The patient recovered from soreness at injection site on 18Mar2021; recovered from diarrhea, nausea, felt like Dumping Syndrome on 26Mar2021; recovered from stiff neck on 26Mar2021 at 10:05am; recovered from constipation on 02Apr2021; and recovered from no appetite and lost 6 pounds on unspecified dates. The patient also recovered from headache with sequelae on unspecified date; and recovered from blacked out on 27Mar2021 with sequelae. The patient had not yet recovered from anxiety reared up; tired; doesn't sleep through the night; back pain, butt and legs hurt, feels like sciatica. No follow-up attempts are possible. No further information is expected.
67 2021-01-03 chills, cough On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, e... Read more
On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, etc.). Noticed some circumoral cyanosis around my lips after arriving home. Had a fine afternoon (sleeping following vaccine and 16 hr. shift). Had dinner and usual evening. Upon going to bed about 11pm, I experienced chills for several hours, and shortness of breath. Very weak. Called 911 about 3 am - went to hospital ER - O2 sat. 90% enroute. Vital signs stable in hospital ER. Had neg. CXR, EKG, and labs. Also had slight cough and slight bronchial congestion. Received some IV fluids in ER. Left ER at 7am. Went home and slept all day, slight nausea in am. Awoke at 7pm - had good breakfast for dinner. Fine evening and night. Off the next day from work - usual day. It was like having Covid all over again (positive X2 in April - out of work for 5 weeks). Although the symptoms began about 12 hrs. following the injection and subsided about 24 hrs. later). My colleagues (work as a nurse in long term care - rehab) who had Covid in the past have experienced similar symptoms following the vaccine, even though we had Covid back in the spring. Dreading vaccine number 2 on Jan. 19th - hopefully I will be ok.
67 2021-01-03 runny nose about 1 hour and 15 minutes post injection (I waited in area as recommended for thirty minutes becau... Read more
about 1 hour and 15 minutes post injection (I waited in area as recommended for thirty minutes because of hx), I had the sudden onset of itchy runny nose and chest tightness and wheezing of significant intensity that I needed to use inhaler then and again later in the day. Noteworthy, I had as a precaution taken prednisone 20mg p.o about 2 hours before the injection. I had to take more later that afternoon because of symptoms. I then seem better but several times since the vaccine I have needed to uses the inhaler and take prednisone more than I have except after an infection about 6 years ago that precipitated similar symptoms to now. Today I had a flare significant enough that except for covid I might have gone to the ER or urgent care.
67 2021-01-04 chills flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a sponta... Read more
flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a spontaneous report from a contactable physician (patient herself). A 67-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 24Dec2020 13:15 in left arm at single dose for covid-19 immunization. Medical history included none. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included methylphenidate hydrochloride (RITALIN) and one-a-day ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS), both from Dec2020 for an unspecified indication. Immediately after vaccine, patient experienced flushing, then lightheadedness, and waves of flushing and chills every minute for several hours; tongue numbness, dry mouth, cold hands and feet; no rash, no breathing difficulty - normal vital signs on 24Dec2020 13:30. Patient received iv diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) and iv hydration after symptoms were not improving 3 hours later - several hours after this treatment, the flushing and chills continued, as did numbness of tongue and dry mouth. Symptoms were still present 22 hours after injection-waves of flushing and chills. The events were reported as non-serious and the events resulted in Emergency room/department or urgent care. Outcome of events were not recovered.
67 2021-01-05 fatigue, headache Headache Fatigue; Arm soreness
67 2021-01-05 headache, fever, chills severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt l... Read more
severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt like 36 hours of bad flu
67 2021-01-06 fever, chills 100 degree fever, body aches, chills, insomnia overnight. Other symptoms still persist . I was unabl... Read more
100 degree fever, body aches, chills, insomnia overnight. Other symptoms still persist . I was unable to work today as scheduled due to these symptoms.
67 2021-01-07 headache, malaise headache, nausea, light sensitivity, neck pain, general not feeling well, not sleeping well
67 2021-01-08 fever Fever Narrative:
67 2021-01-08 sweating welty rash appeared Friday night. very uncomfortable and itchy, clothing swapped, was gone by mornin... Read more
welty rash appeared Friday night. very uncomfortable and itchy, clothing swapped, was gone by morning. Later in the morning, reappeared, mainly on back of thighs and rear end. took 2 tablets of 25mg Benadryl. took a n ap, and rash is gone again.
67 2021-01-11 headache, productive cough, cough phlegm in throat; Headache; Dry cough; It just made her uncomfortable; This is a spontaneous report ... Read more
phlegm in throat; Headache; Dry cough; It just made her uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL1284), intramuscular on the left arm on 04Jan2021 15:01 (she would say 15:01 because they told her to wait 20 minutes after receiving the vaccine and she left at 15:21) at SINGLE DOSE for COVID-19 immunization. The patient stated that she might be a little obese. There were no concomitant medications. When she got the vaccine on Monday (04Jan2021), she felt okay. The next day, it seemed like she had phlegm in her throat. She also had a horrible cough and headache. She don't know if it's the vaccine or what. It was mentioned that the phlegm in her throat was no longer horrible went away by the same day of 05Jan2021. The patient also stated that she took two acetaminophen (TYLENOL) for the headache and it went away last night (05Jan2021). However, she has the headache again by 06Jan2021. It was also mentioned that her dry cough that just won't go away, it's persisting. She can't cough, because people don't like that- they get uncomfortable. The patient mentioned that she didn't see any of these side effects on the paper she was given. It just made her uncomfortable, she didn't know what was going on with her body. Outcome of the events of productive cough and headache (initial occurrence) were recovered in 05Jan2021; recovering from dry cough; not recovered for headache (recurrence) while unknown for the remaining event.
67 2021-01-11 malaise symptoms began as patient was leaving post vaccination, patient began to have a vagal response with... Read more
symptoms began as patient was leaving post vaccination, patient began to have a vagal response with feeling like her heart was racing, HR 80. Patient was observed for 15 minutes. Patient states feels normal. As patient was leaving states she doesn't feel so good. Staff spoke with patient re: symptoms, Patient was observed for 30 minutes. HR was 60 at time patient left. Patient states she feels normal.
67 2021-01-12 fatigue Developed fatigue, chills, body aches
67 2021-01-12 fever Fever; pregnant at the time of vaccination; pregnant at the time of vaccination/Other vaccine same d... Read more
Fever; pregnant at the time of vaccination; pregnant at the time of vaccination/Other vaccine same date; pregnant at the time of vaccination; Other vaccine same date; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (pregnant: yes) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899 and Expiration Date unknown) via unspecified route of administration on 06Jan2021 10:30 AM (Right arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included Diabetes mellitus. No covid prior vaccination, no covid tested post vaccination and no Known allergies. The concomitant drug was reported as atorvastatin (LIPITOR), Metformin, clonazepam. After getting the vaccine (on 07Jan2021 15:00) patient was experiencing fever as a side effect. Patient had other vaccine same date. Patient was pregnant at the time of vaccination. No treatment was received. The outcome of event fever was not recovered. Information on Lot/batch number has been requested.
67 2021-01-12 head discomfort I IMMEDIATELY FELT LIGHT HEADED WITH A FAST HEARTBEAT AND UNSTEADY. MY HEAD FELT VERY HEAVY AND MY B... Read more
I IMMEDIATELY FELT LIGHT HEADED WITH A FAST HEARTBEAT AND UNSTEADY. MY HEAD FELT VERY HEAVY AND MY BLOOD PRESSURE ( WHICH IS NORMALLY LOW WENT TO 160/86). AFTER ABOUT 45 MINUTES I FELT WELL ENOUGH TO DRIVE HOME. MY LAST BP READING WAS 150/75. AGAIN TODAY ( 1 DAY LATER ) AT MID-MORNING I GOT UP FROM DESK AND FELT LIGHT-HEADED AND JUST A BIT UNSTEADY. NOT SURE IF THIS IS AN ALLERGIC REACTION BUT ACCORDING TO PFIZER'S FACT SHEET "FAST HEARTBEAT AND DIZZINESS / WEAKNESS" ARE CONSIDERED SEVERE ALLERGIC REACTIONS!
67 2021-01-12 throat irritation Within 10 minutes started itching on arms, within 45 minutes hives started first on arms, then trunk... Read more
Within 10 minutes started itching on arms, within 45 minutes hives started first on arms, then trunk, neck and ears. During this time throat began to get scratchy. Took two 50mg of benadryl then 1 hour later took one more 50mg of benadryl. Within 3 hours hives and scratchy throat was gone.
67 2021-01-12 fatigue, sleepiness arm is sore; Fatigue; eyes are still heavy; a metallic taste in her mouth; sleepy/eyes are still hea... Read more
arm is sore; Fatigue; eyes are still heavy; a metallic taste in her mouth; sleepy/eyes are still heavy/she is yawning a lot more; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 06Jan2021 at single dose in her left arm for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient had no investigation assessment. It was reported that it had been 24 hours, she received her first bnt162b2 (reported as Pfizer COVID vaccine), yesterday (on 06Jan2021), and she was wondering, her arm was sore on 07Jan2021, which she thought was normal and fatigue on 06Jan2021, she got right away, she didn't know if that was normal, but she got a metallic taste in her mouth on 06Jan2021. It felt like a metallic taste when she swallows, a little metallic taste, yesterday (on 06Jan2021) was more than today, it was after the vaccine, about 7 hours after. She thought in her head, like the aluminum chewing gum, when kids chew it, it had a metallic taste, like the (company name withheld) wrapper she used to chew on it. Provides she was shrinking. Provide she was wearing stretch pants when providing weight. She Googled and didn't see the metallic taste, the only thing she saw with metallic taste is if you have the actual virus, she didn't have it, she was fine. Maybe it was all in her head. Arm was sore not right away, it built up, like when you stretch like with the flu shot, she lifted and it's sore, and she felt sleepy. It was like with the flu shot, it took a few days to go away. Last night on 06Jan2021, she was very sleepy, she was kind of sleepy, but it could be watching the Capitol and insanity, but she was yawning a lot more, her eyes felt heavy, she was ok, she had an appetite and is fine, she would drink (company name withheld) now. Thought she was peaking with it, she would go to sleep early today (07Jan2021), her eyes were still heavy, she wanted to close them and took a nap, but couldn't. It was like her saliva has a metallic taste in her mouth, it may be in her head, she googled to see side effects and when they start, it may be going soon, who knows, she was just wondering. The taste was worse yesterday (06Jan2021), and it wasn't IV or anything like that, the patient wanted to know how can that be. She had to go back on the 27th for her second dose. She had been tested and retested on an unspecified date, and it was offered for those 65 and over, and she was lucky to get an appointment. The outcome of the event metallic taste was recovering; the events fatigue and eyes heavy was not recovered; the outcome of the rest events was unknown.
67 2021-01-13 chills, malaise 5 min post injection- nauseous for a few minutes 9 hrs post injection- severe stomach pain and ... Read more
5 min post injection- nauseous for a few minutes 9 hrs post injection- severe stomach pain and sudden onset vomiting lasting for several hours. Chills and malaise throughout next day.
67 2021-01-13 chills, headache, fever, malaise Low grade fever, severe headache, chills, malaise
67 2021-01-13 body temperature increased Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. ... Read more
Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. Resident was found in the floor of her room. She had fallen and was having a seizure, temperature was 99.7F and Oxygen saturation was 82%.
67 2021-01-13 headache, chills, body temperature increased Temperature , chills, body aches, headache Took 1 Tylenol,Symptoms improved . Only a light headache ... Read more
Temperature , chills, body aches, headache Took 1 Tylenol,Symptoms improved . Only a light headache is left .
67 2021-01-13 headache Within 15 minutes after the shot left upper arms and forearm felt cold; followed by neck (left side)... Read more
Within 15 minutes after the shot left upper arms and forearm felt cold; followed by neck (left side) feeling cold; patient began to have a headache and left lower jaw felt numb. This was also experienced on lip & cheek. Patient was coherent. not dizzy. Patient was being checked on and stayed to about 2:40 PM when patient could feel the numbness subsiding. At 5:40 PM. Patient has a little numbness and a headache on left side of the head. Patient shot was administered on left arm.
67 2021-01-14 head discomfort, lethargy, fatigue 2nd dose: no ae events 1 nd dose:12/24/20 07:30 PM Heavy head at awakening 4:30 AM, spouse drove p... Read more
2nd dose: no ae events 1 nd dose:12/24/20 07:30 PM Heavy head at awakening 4:30 AM, spouse drove pt to work; brain fogginess, fatigue arriving home; pt did not eat for 2 days, lethargic; forced self to hydrate; missed work for 4 days. Large lesion roof of mouth l side to larger two front teeth, very painful, Veltrax PCP. Pt regained appetite as lesion went down in mouth. Lesion has resolved, all other symptoms have resolved.
67 2021-01-14 headache, fatigue, fever Fatigue/lassitude, mild mild headache diarrhea start 8 am on 1/12/21 end 8 am on 1/13/21 approx 6 ... Read more
Fatigue/lassitude, mild mild headache diarrhea start 8 am on 1/12/21 end 8 am on 1/13/21 approx 6 episodes; 2 doses of peptobismol taken no fever
67 2021-01-14 chills, headache INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SIT... Read more
INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SITE RADIATING DOWN THE ARM TO HAND AND INTO THE L SHOULDER (I BELIEVE IT WAS GIVEN TOO CLOSE TO THE NERVE: THIS RXN R/T VACCINE DELIVERY TECHNIQUE; RXN TO VACCINE ITSELF: 32 HOURS AFTER ADMIN, CHILLS, SEVERE ARTHRALGIAS THAT LASTED 12 HOURS AS WELL AS SUSTAINED HEADACHE AND SACRUM ACHE FOR 4 DAYS
67 2021-01-14 headache, head discomfort Vertigo started after lying down the same night of getting the vaccine. Vertigo continued every nig... Read more
Vertigo started after lying down the same night of getting the vaccine. Vertigo continued every night and was accompanied by nystamus upon waking each morning. Symptoms continued for the first several hours after awakening then would gradually get better and was much lighter during the day. Would return every night and next morning and this continued for the next 7 days. My head felt like it was in a fog and it seemed harder to think. It was also very sinus like. No nasal congestion, no post nasal drip, no cough, but my head felt thick and full. I had headaches which I never get. I took my blood pressure to be sure and it was normal. I took Claritin (without the D), Flonase alone and then also Dymista, did the Neti pot, and took Ibuprofen. Headache got better but still had the head fog. Today is post vaccine day 8 and I finally woke up this morning feeling better. Hope it lasts but I answered "Unknown" to Item 20 below because it's too soon to tell.
67 2021-01-14 chills, headache, sweating, malaise received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to hersel... Read more
received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to herself out of bed, needed to wake husband for assistance due to employee being unable to use Right arm. Developed headache, chills, sweats, joint pain Stated "it felt like I was hit by a bus" felt like I got beat up. Wednesday Headache was gone, R arm swollen, lymph nodes at axilla and R neck large as grapes, painful. No appetite, effort to move .Arm was swollen and reddened at injection site.
67 2021-01-15 malaise About 15 minutes after injection, my scalp began to itch all over. Have basically felt unwell for t... Read more
About 15 minutes after injection, my scalp began to itch all over. Have basically felt unwell for the last three days.
67 2021-01-15 headache, fatigue Headache, Myalgia, fatigue
67 2021-01-16 fatigue, fever, chills sore arm redness at the site chills and fever-101.3 fatigue
67 2021-01-17 headache Horrible headache for 30 hours Bad body aches
67 2021-01-17 fatigue States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb a... Read more
States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb and hands felt weak. Did not seek any medical attention. Entirely resolved day of reporting this (1/18/21).
67 2021-01-18 sweating After receiving the vaccine, client verbalized she feels hot and sweaty. Client was evaluated by Fi... Read more
After receiving the vaccine, client verbalized she feels hot and sweaty. Client was evaluated by Fire Rescue on site. Client's symptoms resolved and released to go home per Fire Rescue at 10:28 am.
67 2021-01-18 cough, headache, respiratory tract congestion I got Covid from my husband which he tested positive on 12-26-2020. On 12-26-2020 I tested positiv... Read more
I got Covid from my husband which he tested positive on 12-26-2020. On 12-26-2020 I tested positive for Covid. I developed headaches, cough, congestion along with a sinus infection and had left arm soreness. I also received my 2nd dose injection on 01-06-2021 at 9:30am.
67 2021-01-19 fatigue Presented to ED 1/12 with primary complaint of Fatigue starting that AM. Being treated for Stage IV ... Read more
Presented to ED 1/12 with primary complaint of Fatigue starting that AM. Being treated for Stage IV Sacral Decubitus Ulcer w/ possible osteomyelitis, Still admitted
67 2021-01-19 headache aprox 15 minutes after receiving the vaccine, client started c/o headache and tingling from head to ... Read more
aprox 15 minutes after receiving the vaccine, client started c/o headache and tingling from head to hands, denied difficulty breathing. 11:25 client denies any tingling at this time. She was released to her husband and told to monitor her symptoms.
67 2021-01-20 throat irritation Itchiness to both hands, sensation of scratchiness in throat
67 2021-01-20 throat irritation Pt identified as needing 30 min observation due to previous severe allergies. Pt reports she is feel... Read more
Pt identified as needing 30 min observation due to previous severe allergies. Pt reports she is feeling anxious: about the vaccines, long lines, and wait. RN spoke with her she stated that she experienced an allergic reaction to codeine in the past when she was in the hospital. Pt alert, oriented and calm. 3:20 pt reported she thought her throat was feeling itchy. RN called for assistance to observation room EMS called. Pt agreed to receive benadryl IM and 6L O2; and administered benadryl into left deltoid. EMS/FF arrived, pt declined transport. BP 168/104 taken 138/97, went home with daughter in law.
67 2021-01-20 fever She began to have twitching on the day of vaccine 1/12/2021 but does have a history of seizures seco... Read more
She began to have twitching on the day of vaccine 1/12/2021 but does have a history of seizures secondary to cancer, low grade temp of 99.4 for which she was given tylenol. After the tylenol her fever broke but the lip twitch persisted and her body began to twitch intermittently. She continued to have the twitching throughout the evening and then became unresponsive. She was sent out EMS to our local hospital. She was admitted and returned from the hosptial on 1/19/2021 and state she feels fine. New Diagnosis of Metabolic Encephalopathy
67 2021-01-20 fatigue Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pa... Read more
Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; This is a spontaneous report from a contactable nurse (patient). A 67-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 07Jan2021 09:45 at single dose for covid-19 immunization. Vaccine location was left arm. Patient received the first dose on 17Dec2020 08:45 AM (lot number EK5730) at right arm for covid-19 immunization. Patient is not pregnant. The facility type vaccine was hospital. Medical history included hypertension, elevated cholesterol. Known allergies included Sulfa. Concomitant medication included losartan, hctz, atorvastatin, zinc, ergocalciferol (VIT D). Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore muscle at injection site, fatigue, joint pain on 07Jan2021 10:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021.
67 2021-01-21 influenza like illness, headache, chills 1/7 6:30PM TO 1/8 1PM: ARM PAIN FLU-LIKE SYMPTOMS CHILLS, HEADACHE, BODY ACHES WEAKNESS TOOK TYLENOL
67 2021-01-21 chills, body temperature increased, headache 6PM FELT HOT, DEVELOPED CHILLS. TEMP OF 100.6--TOOK 2 TYLENOL TABS. 5: 30a HAD HEADACHE AND DIZZINES... Read more
6PM FELT HOT, DEVELOPED CHILLS. TEMP OF 100.6--TOOK 2 TYLENOL TABS. 5: 30a HAD HEADACHE AND DIZZINESS-STILL HAD CHILLS. TYLENOL 2 TABS, WATER AND GATORADE.
67 2021-01-21 malaise General malaise with burning sensation inside the body, no fever registered; inflammation of right a... Read more
General malaise with burning sensation inside the body, no fever registered; inflammation of right arm and hand/wrist, migratory joints pains, muscle pain, stabbing pains sudden, neuralgic pain in the extremities. Pain was so severe that cause limitation for walking around the house. The last event on the 7th day was inflammation of the right foot and ankle with severe pain with no history of sprain or trauma.
67 2021-01-21 headache, headache HA, SEVERE NAUSEA
67 2021-01-22 fever Left Arm reddness and hot to touch, red circle 5 inches wide - Approx 4 hr following injection (5:30... Read more
Left Arm reddness and hot to touch, red circle 5 inches wide - Approx 4 hr following injection (5:30PM 1/21/21) Fever 102 at 10PM : Aleve 2 gelcaps for fever and arm discomfort , also used heating pad on Left arm discomfort Woke at 5 AM TEMP 102.2 , arm much better, vertigo significant, took mezcalin anti vertigo RX (had from from weeks virus) took 1 Aleve gelcap Temp assessed at 2PM - 99.2 Temp assessed at 5PM - 98 No anti pyretic taken after5am
67 2021-01-23 fever, malaise In the middle of night started feeling dizzy and developed soreness in arm at injection site.. Over ... Read more
In the middle of night started feeling dizzy and developed soreness in arm at injection site.. Over the next few days, I developed symptoms: slight fever of 99.4 F, diarrhea, unable to eat much, malaise, still dizzy and sort of "blanking out" at times. Arm pain lessened in 2 1/2 days.
67 2021-01-23 throat irritation Irritation on inside of upper and lower lips with some swelling. Very dry and scratchy throat. ... Read more
Irritation on inside of upper and lower lips with some swelling. Very dry and scratchy throat. By 11:00 PM the lower lip was much better. This morning 1/24 lower lip not an issue but upper lip still irritated and swollen on inside of lip. Very dry but no sore throat
67 2021-01-23 chills, fever, sweating, fatigue Within 2 hours of receiving my second Covid 19 vaccine I developed fever, chills, nausea, vomiting, ... Read more
Within 2 hours of receiving my second Covid 19 vaccine I developed fever, chills, nausea, vomiting, myalgias, arthralgias which persisted for 36 hours. After 36 hours, the acute symptoms improved, but I have had persistent daily fever, sweats, chills. The fever has been as high as 102 degrees F orally. The night sweats have been extremely drenching. I also have had ongoing fatigue and have been unable to work or perform my usual activities.
67 2021-01-24 fever, chills, chills, fever Chills and fever
67 2021-01-24 headache, chills The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .aft... Read more
The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .after the 3 days i went back to normal on Jan 22 i wake up with pain in left arm i thought it was due to my neck issue Sunday the 24 th noticed that my Arm is swollen and red check with a primary care provider and been told that i hv cellulitis that he thinks it is from the injection . The Physician prescribed immediately doxycycline 100 mg twice a day for 10 days .. on the 25 i informed my care provider . I started the Antibiotics Jan 24th at 8:00 pm.
67 2021-01-24 chills, fever, fatigue fever (100.4 - 100.9). chills, achy joints, fatigue, nausea
67 2021-01-24 headache yesterday I got a really, really bad headache, that I still have; sore arm; This is a spontaneous re... Read more
yesterday I got a really, really bad headache, that I still have; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration in the left arm on 06Jan2021 at a single dose for COVID-19 immunization. Medical history included lung condition, sarcoidosis, immune system problems, ongoing headache and migraines. Concomitant medication included topiramate for headache and to ward off migraines. States it is in a white bottle, but a pharmacy bottle from (Pharmacy name). She provides discard after 18May2021. Now clarifies it is Topiramate, the generic, 50 mg, it helps ward off migraines. She sees a neurologist for this, not by her internist, she sees the internist who prescribes it twice a year, actually, it is so her headaches don't turn into a migraine, this is just a worse headache, she doesn't know what this is from, hopefully it will just get better. The patient previously took codeine and experienced drug allergy. It was reported that she received the first dose of the vaccine on Wednesday, 06Jan2021. Patient reported that "she's a headache person and gets them all the time." Per the reporter, late yesterday on 10Jan2021, she got a really, really bad headache, that she still have. Could this be vaccine related this far out? The only thing she got right after the vaccine was a sore arm. It's not debilitating (the headache). She is going through a few stressful situations with a friend and her son going through a divorce. She do have a lung condition that's now in remission. She was being followed by a pulmonologist and she is taking something. She is allergic to codeine. She will continue to take Tylenol and will continue to just deal with it." She said that her husband believes the current headache is related to stress. It was further reported that she got the vaccine last Wednesday, on 06Jan2021, she is a headache person, she gets headaches all the time, and takes Topamax (later clarified as the generic, topiramate) on a daily basis, but yesterday on 10Jan2021, late afternoon, she got a really really bad headache, that is still there today, but she didn't get it right after the vaccine, she wondered is that related, or would she have gotten it right away, the headache? States it is not horrible bad, it's just a bad headache, she still wants the second vaccine, and she doesn't want this to interfere, she has a lot of medical conditions, this is why she was afraid to call. Her husband doesn't think this has to do with the vaccine, but she felt like, let her just call. She still has it (headache), she is a headache person, it got better then she got it again, and it also could be stress related, she has been dealing with a few things: she has a friend giving stress, her son is going through a divorce. But she did not get it right after the vaccine, the vaccine was early Wednesday, which is why her husband doesn't think it has to so with anything. Also, she has a lung problem, and thank god she is in remission, she has sarcoidosis, and she has immune system problems, so she has medical reasons. But the issues most important are the lung. She is having blood work done tomorrow, so it has nothing to do with it. States this is good to tell about the stress: she has a friend, a toxic friend, she lives in (State Name), the friend lives in (City Name), and she is a negative person, and she is ending a longstanding friendship, which is not like her, so that is weighing on her mind, and that is, could be, adding to it, and even hurts a little, that's stress, but since she had the vaccine, she thought to call and see. She can definitely get the second dose, right? This report doesn't affect her getting the second dose? After reviewing the call recording, there is no mention of the friend getting the vaccine. The reporter said her friend is giving her stress, and in regards to the statement "weighing on her mind, and that is, could be, adding to it, and even hurts a little, that's stress, but since she had the vaccine", the reporter was referring to herself. Additionally, the statement "But she did not get it right after the vaccine, the vaccine was early Wednesday" the reporter was also referring to herself. The outcome of the event 'headache' was not recovered while unknown for the other event.
67 2021-01-25 chills, sleepiness Exaggerated chills, sleepiness, no fever, slept under 3 blankets for interrupted 15 hrs.
67 2021-01-25 cough but tested covid positive; but tested covid positive; had sinus; a little diarrhea; cough; The initi... Read more
but tested covid positive; but tested covid positive; had sinus; a little diarrhea; cough; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer, reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the right arm at on 30Dec2020 11:15 at a single dose as the patient works for a medical retirement facility. Vaccination was done in a hospital. Medical history included was reported as none. The patient's concomitant medications were not reported. It was reported that the patient got her first shot on 30Dec2020, but tested COVID positive on 13Jan2021, had sinus, a little diarrhea, and cough. She was on quarantine with her husband as of today. She did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. She was asking if she can take the second dose of the COVID vaccine. The patient underwent lab tests and procedures which included COVID virus: positive on 13Jan2021. The outcome of the events was unknown.
67 2021-01-26 chills 7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vo... Read more
7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 11Jan2021 02:45 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 21Dec2020 03:00 at a single dose for covid-19 immunization at the age of 67-year-old as well. On 11Jan2021 09:45, 7 hours after the shot she had severe vomiting, diarrhea and chills. The patient received no treatment for the events reported and was not pregnant at the time of administration of the vaccine. Outcome of the events recovered on an unspecified date in Jan2021. Information on lot number/batch number was requested.
67 2021-01-26 throat irritation Generalized pruritus associated with itchy throat and sensation of throat tightening. Epinephrine 0... Read more
Generalized pruritus associated with itchy throat and sensation of throat tightening. Epinephrine 0.3mg IM and Benedryl 50mg. Symptoms resolved. Refused transport to ED
67 2021-01-26 influenza like illness, fatigue January 8th, I experienced flu like symptoms (aching, tiredness) which I understand this is normal. ... Read more
January 8th, I experienced flu like symptoms (aching, tiredness) which I understand this is normal. These symptoms lasted only aprox. four hours. The other reaction, the one I am concerned about is that my bottom lip began to swell. The swelling continued throughout the night, swelling 3x normal size. It began to recede back to normal within 48 hours. Also, my lymph nodes under my right arm ( the injection arm) was very sore for 48 hours as well.
67 2021-01-26 chills, headache, fatigue The day after receiving the COVID vaccine, patient had headaches, body aches, chills and fatigue. Pl... Read more
The day after receiving the COVID vaccine, patient had headaches, body aches, chills and fatigue. Plans to treat with ibuprofen and/or tylenol
67 2021-01-27 chills Chills for 3 days after the shot
67 2021-01-27 headache, fatigue Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactabl... Read more
Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: Apr2021), via an unspecified route of administration on the left arm, on 12Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included high blood pressure; patient was not pregnant at time of vaccination. Concomitant medications were unspecified (received within 2 weeks of vaccination). The patient experienced nausea, muscle pain, joint pain, headache and tiredness on 13Jan2021 14:00. Treatment was not received for the events. Patient was recovering from the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
67 2021-01-27 fatigue, malaise Pt called the Covid Triage Line wanting to report adverse reactions to the Phizer Covid vaccine she ... Read more
Pt called the Covid Triage Line wanting to report adverse reactions to the Phizer Covid vaccine she received. Pt states she was Covid positive on 12/8/21 and received the Covid vaccine on 1/20/21. Later that day she reported feeling "woozy" and started to feel like she was "drunk" (pt states she has not had a drink since 2005). On 1/21/21 she felt "sick as a dog" and started "violently vomiting". She had a compazine suppository at home that she used which stopped the vomiting. She reports she remained extremely nauseated and fatigued for the next 24 hours. The nausea was only relieved when she would sleep or lie down flat. Pt states she slept the rest of the day on 1/21/21 to "about noon" on 1/22/21 and started to feel better during the late afternoon. She was able to eat dinner 1/22/21. Pt reports she still feels tired but that she is better on 1/23/21. Notified pt's PCP of events who followed up with pt with no further orders. Last note from PCP on 1/27/21. Spoke with pt 1/28/21 and pt states she remains without any further symptoms.
67 2021-01-27 headache, fatigue Spoke with Patient regardingside effects following her #1 Covid Vaccine on 1/15/21. She stated that ... Read more
Spoke with Patient regardingside effects following her #1 Covid Vaccine on 1/15/21. She stated that about 12 hours later developed extreme fatigue, all over weakness, headache, she also c/o intermittent numbness & tingling in bilateral lower extremities (mid-calf to toes) she states that she also has Resless Leg Syndrrome that is untreated. Has been in contact with her PCP. Encouraged her to "Self-Report" to the Vaccine's web-site listed in the Vaccine handout. Encouraged her to call back if she has further concerns or questions.
67 2021-01-28 cough 7:07 Started coughing then became nauseated proceeded to vomit. Nurse suggest after about 10 mins t... Read more
7:07 Started coughing then became nauseated proceeded to vomit. Nurse suggest after about 10 mins that she should take me to ED for Zofran. Upon getting to ED I was wheezing badly and trying to find inhaler in purse; wheezing and unable to catch a breath I was placed in a room, by then my body was turning red and wheezing worse. I was given epinephrine and prednisone immediately for anaphylaxis. They reacted immediately upon my arrival. Time I unsure. I just say thank God for them. Meds Given- Tylenol Duoneb, Decadron, Benadryl, Epinephrine, Pepcid, Nss
67 2021-01-28 headache Almost immediately after taking the vaccine for covid19, I felt extreme dizziness (vertigo). The nu... Read more
Almost immediately after taking the vaccine for covid19, I felt extreme dizziness (vertigo). The nurse had me drink some water and eat some nuts. I had drunk some glucerna that morning for breakfast with my medication. The RN had me wait for about an hour. I then called my primary care doctor who told me to go home and rest. He said that I did not need to go see him or go to a clinic or Emergency Room unless I felt worse. (I have progressively felt better). I left his number and contact information under the contact information above. However, I had received the shot from the Hospital site. I am providing this as you were a little vague in your question about contact address. Anyway, my husband took my temperature about 6 pm. I had a temperature of about 93.8. I normally have a temperature of 98.6 F. He used a digital thermometer. However, I did not feel as if I had asthma. I did have a slight headache then and my arm was a little bit sore. Today (the 29th) my temperature is about normal. I do not have any breathing problems, but my arm is a little bit sore where I got the shot. I still have a slight headache, but it's not too bad. I don't need to take medication for it. There is no redness at the site of the injection. I should mention that one of the RN's did look at my fingernails and the color was normal which I assume means no problems with oxygen levels. I am only reporting this because of the extreme dizziness! I felt a lot better after about an hour after taking the shot, drinking the bottle of unflavored (still) water and eating the nuts. My A1C is back to normal today. (and remember I am not currently needing or taking any form of insulin but my doctor has my blood checked regularly and has for many years). I am only putting no on the item number 20 below because I still have a slight headache and a little bit of soreness in the injection site. Today the site of the injection is not red either.
67 2021-01-28 fatigue Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right a... Read more
Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right armpit, started 24 hrs post vaccine, still occurring; no treatment for anything
67 2021-01-28 sweating, fatigue Night 3 of vaccine woke in am with right mild thigh gnawing, a sensation never experienced before.... Read more
Night 3 of vaccine woke in am with right mild thigh gnawing, a sensation never experienced before. Duration 1-2 hours. Night 4 woke 2 am with more intense discomfort left knee, again not like anything experienced before but did not require Tylenol. It was gnawing and annoying, Night 5 woke around 4 am with left lower leg/ side of foot mild ache which lasted a few hours. Stretching, changing positions had no effect on any of three nights. Day after vaccine while exercising I perspired more than usual and was tired. Did not concern me in any way and would not have reported unless had above symptoms. Question- Do any of the above symptoms indicate I should not get dose 2? Thank you
67 2021-01-28 malaise redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle ... Read more
redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle and joint pain; not feeling well; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) at the 1st dose on 22Dec2020, at the 2nd dose on 12Jan2021; both via an unspecified route of administration at left arm at single dose for covid-19 immunization. Medical history included diabetic and allergies to sulfur drugs. Concomitant medications included other medications in two weeks. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient experienced redness and swelling at injection site, muscle pain, muscle and joint pain, and not feeling well on 24Dec2020. No treatment was received for events. The patient had no COVID prior vaccination. The patient had Covid test post vaccination by Nasal Swab on 11Jan2021 with negative result. Outcome of the events was unknown.
67 2021-01-28 headache, chills, fatigue shaking chills body aches headache fatigue red sore arm
67 2021-01-29 chills, headache, fever Headache, muscle ache, severe chill, fever
67 2021-01-31 headache Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux dise... Read more
Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux disease), symptoms started at 11:30PM while in bed and lasted 1-2 hours; sudden onset and dissipation
67 2021-01-31 fatigue Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion... Read more
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion-Severe, Systemic: Other- mild chest pain, dizziness, feeling like she was going to pass out or fall asleep-Medium
67 2021-01-31 nasopharyngitis, headache day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipat... Read more
day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipated with only small soft BM after product use; self care
67 2021-01-31 fatigue fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 67-year-o... Read more
fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiry date: not reported), intramuscularly, on 14Jan2021 11:15, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered a clinic, not a facility vaccination. There were no additional vaccines administered on same date of the bnt162b2. The patient did not receive other vaccinations within 4 weeks prior to receiving bnt162b2. Medical history included high blood pressure, obesity (has obesity but does not have diabetes), and menopause (10 years). Family history was none. Concomitant medications included metoprolol succinate (METOPROLOL SUCCINATE) for high blood pressure (been taking for 10 years). The patient experienced fatigue on 17Jan2021 10:00 after receiving the first dose of the covid vaccine on Thursday 14Jan2021 11:15. She received her first shot on Thursday (14Jan2021) and everything was fine. She was just experiencing a little bit of fatigue. She would like to know if you would get side effects immediately or after a few days. She wants to know when the side effects typically start after receiving the vaccine. Outcome of the event was recovering.
67 2021-02-01 headache, chills, fever nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This ... Read more
nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This is a spontaneous report from a contactable health care professional nurse, the patient. A 67-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number: EK9231,), intramuscular in the left arm on 07Jan2021 16:00 as a single dose, for COVID-19 vaccination. Medical history included gastrooesophageal reflux disease. Concomitant medication included diltiazem (DILTIAZEM). Patient has no known allergies. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EH9899, on 18Dec2020; 16:00, Intramuscular, right arm,. On 08Jan2021 at 04:00 the patient experienced nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache. The events resulted in a Physician office visit. Lab tests included body temperature: greater than 100 degrees on 08Jan2021. Treatment given include zofran, APAP, fluids, and rest. The clinical outcome of nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache was recovering.
67 2021-02-03 fatigue, fever Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin le... Read more
Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin lesions 4.5 to 7cms/Red spot on my arm; Low grade temperature elevation; Fatigue; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899, reported as "SARS-COV-2 then it says Pfizer EH9899", expiry date: Unknown), subcutaneous on 05Jan2021 at single dose for COVID-19 immunization (reported as "To not get COVID 19"). Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) 25mcg, once a day for hypothyroidism. The patient got the vaccine last Tuesday (05Jan2021). When she got the vaccine, the gentleman was from military who gave the vaccine. The patient does not believe that he gave it intramuscular (IM), she believed that he gave it "subQ" because she had no muscle tenderness and "skin a 4.5 by 7cm skin reaction", and it was nowhere near the deltoid muscle. The patient had a high degree of suspicion that he gave it "subQ" (subcutaneous). When asked for the anatomical location of administration, the patient stated that "He gave it on my right arm but it was not into the deltoid, I think he gave it subcutaneously. I am not positive of that but missed the deltoid, it was lower, it was below the deltoid, it was in between the deltoid and the bicep and I am assuming it was subQ because none of my muscles were sore at all after getting the vaccine, accept that big red spot on my arm". Patient asked "Now my question to you is because I looked through all your literature and I can't find anything about this". Since then the skin lesion within a couple of days it was up to about 4.5 to 7cms. It was still about that size however the redness has gone way down, "the not redness", just pink, the swelling was almost gone. The heat coming out of it was almost gone. The patient mentioned that the actual skin region was much better, it was still about the same size though. Patient was not too worried about that and stated "what am concerned about is what I've also have is a low grade temperature elevation and some fatigue. If I got it on 3 O'clock on Tuesday the 5th that would be day 9. Is the 9 days post injection for dose 1 to still have a low grade temperature elevation and some fatigue. Is that acceptable or does that indicate a problem?". Patient stated the she went to her internist and he had a look at it and he said "I had no idea, he said that they just don't have experience like this. Do you have a phone number that I can talk to somebody?". The patient was about 5' 7" (height) and about 175 pounds (weight) approximately. The patient stated that fatigue and temperature elevation started one or two days after the vaccine (Jan2021). Patient reported that she still have it. The fatigue was much less but it was there and low grade temperature elevation was still there. There was no investigation assessment. The patient assessed that the events swelling, redness, skin lesions, temperature and fatigue were related to COVID-19 vaccine, also reported as "Yes, because I never had that before and I am not taking anything now. So, it is like yes. It is definitely because that. The two main symptoms I am asking about are the fatigue and the low grade temperature elevation". Outcome of the events fatigue and skin lesion, redness, swelling and heat coming out was recovering, for low grade temperature elevation was not recovered.
67 2021-02-03 cough, fever Temperature of 100.1; cough; This is a spontaneous report from a contactable consumer. who is the pa... Read more
Temperature of 100.1; cough; This is a spontaneous report from a contactable consumer. who is the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982, expiration date unknown), via an unspecified route of administration in the left arm on 16Jan2021 (at the age of 67-years-old) as a single dose for COVID-19 vaccination. Medical history included blood pressure, restless leg syndrome, cholesterol, triglycerides, unknown rash, Vitamin B-12 deficiency and Viamin D deficiency. Concomitant medication included olmesartan medoxomil (BENICAR) for blood pressure, fenofibrate (FENOFIBRATE), doxepin (DOXEPIN), levocetirizine dihydrochloride (XYZAL), clonazepam (CLONAZEPAM), colecalciferol (VITAMIN D3) and cyanocobalamin (VITAMIN D12). It was unknown if the patient has any allergies to medications, food, or other products. It was unknown if the patient had received any other vaccines within four (4) weeks prior to the vaccine. The patient stated that she started yesterday, 19Jan2021, with a cough and today, 20Jan2021, the patient developed a temperature of 100.1. After taking Tylenol "at 12" her temperature was 99.6. She noted that her normal temperature is 96.8. Treatment information included Tylenol. The clinical outcome of cough was not recovered and the clinical outcome of fever was unknown.
67 2021-02-03 cough cough; started with a temperature; This is a spontaneous report from a non-contactable consumer (rep... Read more
cough; started with a temperature; This is a spontaneous report from a non-contactable consumer (reporting for her mother). This 67-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date unspecified) on unspecified date in Jan2021 (at 67 years of age) as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On Jan2021, the patient experienced cough and started with a temperature. Outcome of event 'cough' was unknown and 'started with a temperature' was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
67 2021-02-03 chills, fever one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she start... Read more
one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events low grade fever, chills and nausea cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
67 2021-02-04 chills, fever Chills; Fever; cool; Night sweats; Soreness in arm; This is a spontaneous report from a contactable ... Read more
Chills; Fever; cool; Night sweats; Soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EK9231), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Blood pressure, ongoing Cholesterol. Concomitant medication included nifedipine (ADALAT) for Blood pressure and ongoing, atorvastatin (ATORVASTATIN) had been on this medication 6-7 year and ongoing for Cholesterol. Historical Vaccine included flu and had Soreness in her arm. The patient experienced soreness in arm on 20Jan2021; chills, cool, fever, night sweats on 21Jan2021. She woke up drenched. She imagined the fever was breaking. She woke up, and did not have a fever, and was fine other than that; She just couldn't warm up. She was cool, and the chill wouldn't go away with clothes or blankets or the fire place. The event outcome of soreness in arm was recovering, outcome of other events was recovered on 21Jan2021.
67 2021-02-04 throat irritation Face got red and warm and a burning sensation in her throat. Gave Benadryl PO. Continued to monitor ... Read more
Face got red and warm and a burning sensation in her throat. Gave Benadryl PO. Continued to monitor for 30mins and patient still complained of burning and tightness in throat. Called her family and they drove her to the ER. I have spoken with patient and she has had to go to the ER a total of 3 times.
67 2021-02-04 chills, fever Fever; Ache; Chills; Feeling miserable; Fever/Ache/Chills/Feeling miserable; This is a spontaneous r... Read more
Fever; Ache; Chills; Feeling miserable; Fever/Ache/Chills/Feeling miserable; This is a spontaneous report from a contactable consumer. This 67- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL3246), via intramuscular route of administration, on 19Jan2021 at 10:30AM (at the age of 67-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The medical history included: Blood pressure high, Diabetes, Hypothyroidism, High cholesterol, all from unspecified dates and ongoing. Patient's Medical History (illness at time of vaccination): States that she was concerned because she thinks she has had a sinus infection for the last week; hasn't been feeling well. She told her doctor about it and asked if it was still okay to get the vaccine and was told that it would be fine. Concomitant medications included FLUTICASONE PROPIONATE (FLONASE) and montelukast sodium (SINGULAIR), both for Allergy. The patient received first dose BNT162B2 on 28Dec2021, (Lot: EJ1685, Expiry/NDC: Unknown), in right arm (Her arm hurt for about a week). Patient's Medical History (illness at time of vaccination): States that she was concerned because she thinks she has had a sinus infection for the last week; hasn't been feeling well. She told her doctor about it and asked if it was still okay to get the vaccine and was told that it would be fine. Prior vaccination included: Pneumonia vaccine - States that her arms swelled up and turned red the day she got the vaccine. The next day she had chills, fever, and body aches; and she had a rash on her arm that started the day after the vaccine. Her doctor told her not to get the vaccine again. She does not have the Lot/NDC/Expiry to provide because it was many years ago. Prior vaccination: Flu shot - She swells up and turns red at injection site; she also gets fever, chills, and body aches with it as well. She does not have the Lot/NDC/Expiry to provide; she got it back in Oct2020 at the Hospital where she works. On 20Jan2021 03:00 AM, the patient experienced fever, aches, chills, and feels miserable. States that she reacts to the flu shot too, but nothing like this. Stated that all the events started in the early hours of the morning, around 3:00AM. She pushed herself to go to work, and it just got worse throughout the day. States that she has been alternating Tylenol and Ibuprofen since early this morning. The outcome of events fever, aches, chills, and feels miserable was not recovered, got worse through the day was unknown. No follow-up attempts are possible. No further information is expected.
67 2021-02-04 throat irritation Itchy throat - helped with Benadryl 25 mg PO. O2 sat 100%. BP: 172/76, 151/77. Pulse 63. Discharged ... Read more
Itchy throat - helped with Benadryl 25 mg PO. O2 sat 100%. BP: 172/76, 151/77. Pulse 63. Discharged to home.
67 2021-02-04 fatigue bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued... Read more
bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued; This is a spontaneous report from a contactable Nurse (the patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685, expiration date unknown), intramuscularly in the left arm, on 28Dec2020 as a single dose for COVID-19 vaccination. Medical history was not reported. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 28Dec2020 the patient experienced fatigue. On 29Dec2020 the patient states that her feet were numb bilaterally and her hands felt weak. The patient did not seek any medical attention and no treatment of the events was reported. The clinical outcome of fatigue, numbness of feet and weakness of hands was recovered (reported as "resolved entirely on its own") on an unspecified date.
67 2021-02-05 chills, headache, fever Fever of 100, chills, muscle and joint aches and a headache began about 2:00 am, throughout the day ... Read more
Fever of 100, chills, muscle and joint aches and a headache began about 2:00 am, throughout the day on Friday the aches increased. Slept quite a lot. Took Tylenol and Advil, alternating them and then at bedtime took 1 of each. Joint aches have decreased on Saturday, but the fever and chills are still coming and going.
67 2021-02-05 headache, fatigue Headache, light headedness, spike in blood pressure of 180/106, fatigue, racing heart rate
67 2021-02-06 fever, headache, chills Fever, headache, muscle pain, chills, joint pain, fever.
67 2021-02-06 malaise Swollen glands in upper right neck, under jaw Tightness in chest; shortness of breath Malaise I fee... Read more
Swollen glands in upper right neck, under jaw Tightness in chest; shortness of breath Malaise I feel like I have the mumps
67 2021-02-07 fatigue, headache, fever Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; D... Read more
Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; Diarrhea; Abdominal pain; Joint/muscle pain; Joint/muscle pain; Nausea; Fatigue; Severe headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration in the right arm on 15Jan2021 13:00 at SINGLE DOSE (first dose) for COVID-19 immunization. Medical history included systemic lupus, "hypothyroid", Leiden Factor V. Patient's known allergies: penicillin, erythromycin and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included hydroxychloroquine, clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity, tetracycline and experienced drug hypersensitivity. On 15Jan2021 16:00, the patient experienced fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm. Outcome of events was fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm not recovered. Outcome of the other events was unknown. Patient did not receive any treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
67 2021-02-08 fatigue, headache, chills, malaise 8 hrs post vaccine, got headache, chills, no fever, felt like the worst flu I ever had for 12 hrs, ... Read more
8 hrs post vaccine, got headache, chills, no fever, felt like the worst flu I ever had for 12 hrs, felt slightly better but still quite ill, tired, joint ad body aches, headache. Could not eat or get out of bed
67 2021-02-08 headache Day 2 - Had a bad headache but that went away by day 3. Day 4 I started to notice a tenderness in m... Read more
Day 2 - Had a bad headache but that went away by day 3. Day 4 I started to notice a tenderness in my right thigh and a rash started to appear. The entire front of my thigh is very tender. Plus my body just seems to feel achy.
67 2021-02-08 chills, malaise Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unw... Read more
Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation. Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3. Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills. Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-02-09 malaise COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfiz... Read more
COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A 67-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 09Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on 18Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 18Jan2021. She was still sick. The information on the Lot/Batch number has been requested.
67 2021-02-09 fatigue, sweating Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb a... Read more
Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb and go numb a bit; arm began to hurt then throb and go numb a bit; The patient was cold; clammy; the first blood pressure was 90 over something/second blood pressure was 70 over 40 something; diarrhea; tired; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 3247), via an unspecified route of administration in the left arm on 18Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 18Jan2021 10:10, the patient's arm began to hurt then throb and go numb a bit. On 18Jan2021 10:15, the patient started sweating. She stood up to try and feel better. The patient's husband called the nurse over and they called the paramedics because they said the patient was cold, clammy, and still sweating. The patient sat down again and they put leads on me to check her heart rate, blood pressure (BP), and oxygen on 18Jan2021. Her heart rate and oxygen were fine but the first BP was 90 over something. A few minutes later, she closed her eyes and could have fallen asleep right there. Her second BP was 70 over 40 something. She opened up her eyes and tried to stand up again. After a few more minutes, her BP came up and was OK. They refused an ambulance and went home. She had diarrhea at home on 18Jan2021. She ate, walked and felt better. She just experienced the normal tired and hurt arm in the afternoon on 18Jan2021. She rested the balance of the day. On Wednesday (20Jan2021), she got a bumpy itchy rash on both legs which is still present but with cream, it was OK. No treatment was received for the adverse events. Outcome of the "the first blood pressure was 90 over something/second blood pressure was 70 over 40 something" was recovered on 18Jan2021 and of the remaining events was recovered on Jan2021.
67 2021-02-09 headache On a scale of 1-10, 10 being the greatest, I had a little slight, may be like a little slight headac... Read more
On a scale of 1-10, 10 being the greatest, I had a little slight, may be like a little slight headache like I will give that a 2; This is a spontaneous report from a contactable consumer. This 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EE3247), via an unknown route, on 23Jan2021 (at 11:20) at a single dose for COVID-19 immunisation. Relevant medical history included high blood pressure. Relevant concomitant medications included amlodipine. The patient stated, 'on a scale of 1-10, 10 being the greatest, I had a little slight, may be like a little slight headache like I will give that a 2' that night, the night I had got the injection". The outcome of the event was unknown.
67 2021-02-09 chills, malaise, headache, fatigue Very bad arm pain on injection arm; tiredness; mild headache; chills; feeling unwell; This is a spon... Read more
Very bad arm pain on injection arm; tiredness; mild headache; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient received bnt162b2 (BNT162B2 also reported as COVID 19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm on 16Jan2021 10:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included allergy to latex, iodine, motrin. No other vaccine in four weeks. There were no concomitant medications. On 16Jan2021 15:00, the patient experienced very bad arm pain on injection arm, tiredness, mild headache, chills, feeling unwell overall for 4 solid days. No treatment was given. The outcome of events was recovered on 20Jan2021. Information about lot and batch number was requested.
67 2021-02-09 fatigue, chills chills; weak; feeling very tired; This is a spontaneous report from a contactable consumer (patient)... Read more
chills; weak; feeling very tired; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 67-year-old female patient received first dose of bnt162b2 (lot/batch number not provided), via an unspecified route of administration on 21Jan2021 at 1:00 (unspecify AM/PM) at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her 1st dose of vaccine, on the 4th day (25Jan2021) she feels weak, have chills and no fever. It was reported that it has been four days since she had her first Pfizer injection of Covid vaccine. Stated that she is feeling very tired, weak and has no chills (pending clarification). Stated that she is four days into it. Stated that she had the vaccine at 1:00 on 21Jan. Stated that she has the list with chills which says that they are normal. Wanted to know if this is normal. The outcome of the event was unknown. Information on the lot/batch number has been requested.
67 2021-02-10 headache, chills HEADACHE THE FIRST EVENING CHILLS BUT NO FEVER THE SECOND DAY
67 2021-02-11 chills Diarrhea, vomiting, rash, mild hives, chills, episode of delirium
67 2021-02-11 malaise, cough, headache, body temperature increased On Christmas day I was working and then you started feeling like a pinching in my chest, like when y... Read more
On Christmas day I was working and then you started feeling like a pinching in my chest, like when you are going to catch a cold, that went on through the afternoon. In the afternoon I started with light headache and dry cough (intermittent), no temperature. I did not take anything for it and continued working. When I got home, I felt weak and was supposed to join my family for Christmas and decided not to go. And went to sleep. The next day (Sat) I was still not feeling well, weakness on my limbs, I went to the hospital to see if I could get checked and they told me to return on Monday because Occupational Health was closed on the weekends. I went home and treated myself with Tylenol and Vitamin C. On Monday I got tested and was positive. By then, I was coughing, limbs weak, had temperature (101F). I started to get weaker an weaker and Tuesday or Wednesday my work called me and asked me if I would like to come see a doctor. Wednesday I started with shortness of breath. I called my PCP and he prescribed me an albuterol inhaler. It helped me but my cough got worse by Saturday. My doctor then told me to go to the hospital (I live by myself). At my choice I went to Medical Center and were admitted and was hospitalized for 6 days. They kept treating me with inhaler and oxygen. They wanted to send me to rehab but I told them I wanted to go home. I came home with oxygen and with albuterol inhaler and the ambulance had to bring me home. I still was feeling very weak, had cough, and had the shortness of breath. And I have been home since then. I have home health and a therapist that come check on me 2X a weekly.
67 2021-02-11 fatigue she felt so tired; her breathing was heavy and felt tight; This is a spontaneous report from a conta... Read more
she felt so tired; her breathing was heavy and felt tight; This is a spontaneous report from a contactable nurse. A 67-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9262), at age 67 years, injection into the left upper arm/deltoid, first dose on 27Jan2021 14:00 at single dose, for COVID-19 vaccination. Ongoing medical history included diabetes diagnosed more than 10 years ago and high cholesterol diagnosed around 10 years ago, maybe longer. The patient's concomitant medications were unspecified maintenance medications because she is diabetic and has high cholesterol. She said that she has been taking these medications for a long time though already. Patient was a retired registered nurse that was calling about the COVID-19 vaccine and reported that she had the first dose injection on 27Jan2021 at 14:00 and 2 hours after she got home, she felt so tired that she did not feel like moving and her breathing was heavy and felt tight. Patient said that her breathing feeling heavy and tight did not last too long, maybe an hour then went away. Her tiredness, felt so tired lasted through the day and whole night and she was fine and completely recovered after waking up in the morning. For breathing feeling heavy and tight: She clarified that it lasted from like 14:00-17:00 yesterday 27Jan2021. Patient wanted to know with the symptoms she had is it contraindicated to get the second dose? She was reading the information about the injection and seemed like the symptoms are part of it. The outcome of the events was recovered, for felt so tired was on 28Jan2021 and for breathing was heavy and felt tight was on 27Jan2021. Case was reported as serious with other medically important condition as seriousness criteria. The reporter assessed the events she felt so tired and her breathing was heavy and felt tight as related to the suspect drug COVID-19 Vaccine. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-02-16 headache Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyano... Read more
Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyanosis. EMS gave a breathing tx, O2 sats WNL. Declined transfer to hospital at that time for fear of Covid. Client exhibited confusion, oriented x 0, short term memory loss. Bronchial spasms resumed, EMS again called, transported via EMS to MC. Diagnosed with transient global amenesia and hypercapnia. Client was transported to MC for CT and MRI for r/o stroke. Stroke was ruled out. Client with c/o severe H/A, nausea, dizziness, myoclonic seizures. Severe h/a which lasted 4 days. Still experiences mild memory loss, confusion, and h/a are becoming less severe. Client states that sensory processing is slowed
67 2021-02-16 chills, fever Very weak, fever 39.9, chills for three days
67 2021-02-16 throat irritation Within 15-minutes of vaccination, the patient reported nausea, pruritus on bilateral feet, her throa... Read more
Within 15-minutes of vaccination, the patient reported nausea, pruritus on bilateral feet, her throat "feeling itchy and weird", and that it was hard to swallow. EMS evaluated patient on-site and was found to be hypertensive (182/133). Administered 4mg Ondansetron PO and 50mg Benadryl IV. Patient was transported to ED for evaluation. In the ED, patient was hypertensive (191/85) but noted feeling better after Benadryl IV. No evidence of worsening allergic reaction or respiratory distress. Patient was discharged from ED with instructions to follow-up with PCP.
67 2021-02-21 fever, cough 103 fever, difficulty breathing, chest cough, not coherent
67 2021-02-21 sleepiness Blurred vision, benign vertigo, immediately after vaccine given. Corrected itself over the next hou... Read more
Blurred vision, benign vertigo, immediately after vaccine given. Corrected itself over the next hour. But at 4:30 am 2/22/2021 I was awakened by intense itching on my left arm and hand. Over the next 2 hours the itching increased in intensity and progressed to my right arm and hand, over my upper back and shoulders, and along the back of my thighs and buttocks. I took 2 Benadryl allergy tablets (25mg) and used Benadryl GEL extra strength on the affected areas. This resulted in my sleepiness for the remainder of the day. Contacted my physicians office for an appointment to resolve the issue.
67 2021-02-21 headache Full body aches Insomnia Headache Difficulty concentrating Temp low
67 2021-02-21 fatigue I received the 2nd Covid injection. I went to the 15-minute waiting area. The waiting area was ful... Read more
I received the 2nd Covid injection. I went to the 15-minute waiting area. The waiting area was full, so my husband and I were standing. I stand and work every day, so this was not difficult. I texted my daughter, who is a hospital employee, and told her that we had a super experience with no wait and had already received our 2nd dose. However, 5 to 7 minutes after the injection, I SUDDENLY felt dizzy and weak and had to sit down. Within a minute or so, I could not stand or open my eyes. The weakness made it difficult to breath or talk. My husband had to lift me up into a wheelchair. I was taken to the ER. For the longest time, I could not even open my eyes or talk above a whisper. After 4 hours, I was able to get my eyes open and talk better. I, gradually, was able to move my hands and feet. Last of all, I could move my hips and walk. It was as if my body had been put to sleep. I could feel everything but my body wouldn?t move. As it wore off, my face and limbs felt slightly tingly. I was, basically, fine after 5 hours other than being tired from the experience. The doctors had no explanation for what happened and said it must be an emotional response to getting the shot. They wrote that I was not exerting enough effort to move my body. One said that I was hyperventilating when I pulled my mask up to breathe after he told me to hold my leg in the air. Though I tried, I was too weak to hold my leg up and it fell to the bed. The doctor told me that I should not tell anyone about what had happened or people would not come to get the Covid vaccination. He obviously knew that SOMETHING had happened that I couldn't control but he didn't put that in his report!
67 2021-02-21 sweating, chills, headache Too dizzy to pen eyes, nauseous, diarrhea, headache, chills, sweating, duration about 6 hours, recov... Read more
Too dizzy to pen eyes, nauseous, diarrhea, headache, chills, sweating, duration about 6 hours, recovery within 10 hours
67 2021-02-21 chills dizziness. Patient felt normal after drinking water. Sx resilved monitored for about 15-20 minutes ... Read more
dizziness. Patient felt normal after drinking water. Sx resilved monitored for about 15-20 minutes after symptoms resolved. PSOB, palpitations, chills, ED Precautions discuseed. BP 160/90 Hx High Blood Pressure T98.0 New BP 151/81 HR 78 #21 allowed to go home advised to contact pcp if symptoms recur or
67 2021-02-22 fatigue I got very tired and I felt achy. I started feeling a tingle and numbness in my hands and fingers. I... Read more
I got very tired and I felt achy. I started feeling a tingle and numbness in my hands and fingers. I had pain around the base of my thumb on my left hand.
67 2021-02-22 fever, fatigue Note: this was a POSITIVE effect worthy of study! I was resigned to being a long hauler after 8 werk... Read more
Note: this was a POSITIVE effect worthy of study! I was resigned to being a long hauler after 8 werks of 100 degree fever and fatigue, but on 3rd day after first Pfizer vaccine, I woke up totally symptoms free. Did the vaccine give me something my body couldn?t produce, or just push my immune system to kick out a new round of fresh antibodies? This could be extra good news for longhaulers. Should be studied.....
67 2021-02-23 head discomfort, influenza like illness, cough, chills, fever, malaise, lethargy, sneezing 2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like fee... Read more
2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like feeling, "heavy head", lethargic 2/9-2/10: Pretty much back to normal with the addition of an injection site "hot spot"- raised, rashy and feverish 2/11: Began feeling general malaise in the afternoon. Low grade fever, pain behind collarbone on both sides. By 7pm, severe chills. 2/12: Called PCP and advised of symptoms. Went and got a Covid19 PCR test just in case. Negative 2/13-2/15: Still had low-grade fever (usually around 100*) which often didn't present until 2pm and then stayed until bedtime. Glands became swollen, bad night sweats. Pain behind collarbone worse when sneezing, coughing, yawning, burping, etc. Additional information for Item 18: Almost like a "catch" rather than constant pain. 2/16: Went to local medical center for drive-thru rapid Covid 19 and flu test. Both came back negative as did the PCR Covid test they also ran. 2/17-2/20: Symptoms pretty much the same....no fever in the am and thought I was finally getting better, then it would spike again around 1:00-2:00. Never over 101*. On the morning of 2/21, the "catch" around the collarbone had moved down to the bottom of my ribcage. 2/22: Contacted PCP again and made appointment for bloodwork, chest x-ray, and further tests. "Sick and tired of feeling sick and tired!"
67 2021-02-23 fever, headache, malaise, fatigue Bitter taste in mouth immediately after shot. A few hours later bad headache, nausea, injection sit... Read more
Bitter taste in mouth immediately after shot. A few hours later bad headache, nausea, injection site pain and redness and swelling , tiredness, muscle and joint pain, slight fever, feeling unwell. Lasted 5 days.
67 2021-02-23 cough Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness. P... Read more
Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness. Patient monitored for 30 minutes by EMS, VSS, lung sounds clear, SPO2 100%. Patient remained on-site for an additional 15 minutes then went home.
67 2021-02-23 headache Pt. from tent 16 in observation lane complained of fluttery chest, difficulty swallowing, headache, ... Read more
Pt. from tent 16 in observation lane complained of fluttery chest, difficulty swallowing, headache, dry mouth. Paramedics assessed pt. once symptoms subsided paramedic released pt. to leave.
67 2021-02-23 fatigue nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at ... Read more
nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at the injection site; itching going on in my face, my left arm, in the elbow / stomach about 2 inches to the left where they made the incision for the cancer removal; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration into left arm on 06Feb2021 (at the age of 67-years) as a single dose for COVID-19 immunization. Medical history included allergic to peanuts, allergic to Penicillin, cancer and hysterectomy. There were no concomitant medications. The patient previously took vancomycin, cefalexin (KEFLEX) and zelnorm and was allergic. On 06Feb2021, the patient had pain at the injection site, but that was gone now. She also experienced rash, which was elaborated as an itch, like a rash that started since she got the shot. She had the itching rash going on into her face, left arm, the elbow, and also 2 inches from naval on the left side where she had incision from cancer removal, hysterectomy. The rash was started in the area of the hysterectomy. The patient elaborated that the rash was red and she can feel bumps. The patient was taking diphenhydramine hydrochloride (BENADRYL) which usually stop the itching. Last night 06Feb2021, the back of her left elbow and her face started itching as well and at 23:30 the patient experienced nausea and felt tired. The patient is scheduled for second dose on 27Feb2021. The clinical outcome of event rash is red and she can feel bumps was not recovered. The outcome of pain at the injection site was recovered in Feb2021. The clinical outcome of other events was unknown.
67 2021-02-24 fever, chills Fever (101) chills, body aches lasting about 12 hours
67 2021-02-24 fever running fever; This is a spontaneous report from a contactable consumer reporting for herself. A 6... Read more
running fever; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration in the right arm on 06Feb2021 15:30 at single dose for covid-19 immunisation . Medical history included blood pressure abnormal and blood cholesterol increased. The patient experienced running fever on 08Feb2021 20:00 with outcome of not recovered. The patient was hospitalized on an unknown date for running fever . The patient underwent lab tests and procedures which included body temperature: still running temp on Feb2021, Sars-cov-2 test: negative on 12Feb2021. The patient has received antibiotics as a treatment for pyrexia. At the time of the vaccination the patient was not pregnant and after being vaccinated she was tested negative to Sars-Cov-2 Information on the lot/batch number has been requested.
67 2021-02-25 fever, headache, chills, fatigue Chills, low-grade fever (99 - 100), headache, body ache, fatigue - lasted for two days, then lifted.... Read more
Chills, low-grade fever (99 - 100), headache, body ache, fatigue - lasted for two days, then lifted. One day of feeling fine, then the next day starting getting stomach cramps in waves, then more chills and fatigue, which lasted through that day; by afternoon of the next day I felt fine.
67 2021-02-25 headache I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My ar... Read more
I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My arm was just little uncomfortable; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; I am getting nightmares, it's like I am struggling; Fibromyalgia/never have 'flare-up' this bad; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL1283; expiration date: unknown) at 67-year-old age of vaccination via an unspecified route of administration in the left arm on 21Jan2021 at a single dose for covid-19 immunization. Medical history included fibromyalgia. The patient's concomitant medications were not reported. The patient reported that she got her vaccine on a 21Jan2021 (Thursday) and on Friday (22Jan2021), her arm was just little uncomfortable but its fine. On Saturday by 4 o' clock (23Jan2021), she really hurt so bad all over and with headaches. By Sunday (24Jan2021), it went down a little bit and it was going away but last night (unspecified date in 2021), it hit again it just waking her up and she was getting nightmares, it's like she was struggling. She mentioned that she has a history of Fibromyalgia, but she never has 'flare-up' this bad on unspecified date in 2021. It was reported that the patient with fibromyalgia was given Pfizer Covid-19 Vaccine. She further stated that she hurt all over like right leg, left leg, upper body. The patient received treatment of acetaminophen (TYLENOL). The adverse events did not require an emergency room/ physician office. She mentioned that she has read all literature, it says you can get side effects, but this isn't normal. The outcome of the events limb discomfort, pain and headache were recovering while the outcome of the other events was unknown.
67 2021-02-25 fatigue, chills Muscle aches, chills and severe joint pain 9:05PM Treatment: went to bed at 10:00 P Following day 2/... Read more
Muscle aches, chills and severe joint pain 9:05PM Treatment: went to bed at 10:00 P Following day 2/25/2021: 7:45 AM extreme fatigue, loss of appetite, taste buds off Treatment: naps, fluids 02/25/2021 9:00PM mild muscle aches and joint pain
67 2021-02-25 chills Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patien... Read more
Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine 2nd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand All Collapse All 2/24/2021 Patient Date: 2/24/2021 Subjective is a 67 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, drooling, hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes none. She does not take any medications but is on Vyvanse.none. She denies any medial hx. Not on any medications. She did drink a protein shake this am. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, chest tightness and itching of skin (to R shoulder/injection site area) Patient denies fever, malaise/fatigue, nasal sores, sneezing, sore throat, frequent throat clearing, cough, shortness of breath, wheezing, rash, hives, eczema, abdominal pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 1024 02/24/21 1029 BP: (!) 180/73 (!) 150/90 Pulse: 71 SpO2: 97% Blood Sugar 108 collected at 1050 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Findings: No rash. Comments: Injection site and R arm without erythema or swelling. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) PT monitored and improving. Pt ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Pt aware of what to monitor and when to go to ED. Pt voiced understanding and appreciated. Pt able to ambulate out of the facility with ease. APRN Electronically Signed 2/24/2021 12:27 PM
67 2021-02-25 malaise, headache itching on the skin of the back; Headache; malaise; This is a spontaneous report from a contactable ... Read more
itching on the skin of the back; Headache; malaise; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 04Feb2021 at 09:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date in Jan2021 (age at vaccination: 67 years) at 09:00 on the left arm for COVID-19 immunization. Prior to vaccination, was the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced itching on the skin of the back, headache and malaise on 05Feb2021 at 07:00. It was unknown if the patient received treatment for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
67 2021-02-26 chills, headache Chills, muscle aches, headache. Gone in 12 hours. No treatment other than rest.
67 2021-02-26 headache, fatigue Dose was injected at 9:30 am and around 1 pm, my neck started to stiffen up and get sore on both sid... Read more
Dose was injected at 9:30 am and around 1 pm, my neck started to stiffen up and get sore on both sides and up into occipital region. It was very painful and difficult to turn my head in either direction. It started to ease after 5 or 6 hours but my neck still feels somewhat sore now which is 3 days later. My injection site was throbbing and painful from elbow to shoulder from about 1 pm until about noon the next day. I did not experience any fever but felt tired.
67 2021-02-26 chills, fever Fever, aching, (severe) chills, (a little) nausea, unable to get out of bed for 30 hrs, symptoms con... Read more
Fever, aching, (severe) chills, (a little) nausea, unable to get out of bed for 30 hrs, symptoms continued for 48 hrs toatal.
67 2021-02-27 malaise, fever, chills, fatigue, headache Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fe... Read more
Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fever, headache, muscle/joint pain, nausea, dizziness with made it difficult to walk to the bathroom d/t the dizziness, general unwell feeling. I took tylenol. I applied ice packs to my neck and core body area. I was confined to the bed until Friday apprx 11:00 am until I could get up. I continue to feel "funny" in the head at times. I did not seek any Dr or hospital visit.
67 2021-02-28 headache About six hours after the injection I experienced discomfort in my throat, mild swelling in both han... Read more
About six hours after the injection I experienced discomfort in my throat, mild swelling in both hands and face, some tingling in face, and head ache.I took Zyrtec 10 mg, Pepcid AC 20mg. Then I started to have tightness in my chest and used my albuterol inhaler. I was still having symptoms an hour later so took Benadryl 25 mg. During the night I woke up with mild wheezing and used my inhaler again. Throughout the next 2 days, I continued to have these symptoms (except for wheezing) off and on. Today, I still have some symptoms but not as often or severe.
67 2021-02-28 sweating Approximately 5-10 minutes after receiving the vaccine, patient began sweating, feeling dizzy and dr... Read more
Approximately 5-10 minutes after receiving the vaccine, patient began sweating, feeling dizzy and dry heaving. BP was normal as well as HR. This has happened before with vaccines and other needle sticks like blood draws. Patient was given and ice pack to help her cool down and after about 10-15 more minutes, patient was calm enough to leave the vaccine observation area.
67 2021-02-28 lethargy Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid... Read more
Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid as well; Rapid heart beat for about an hour second day, but could be thyroid as well; Sore arm, not severe; Lethargic for a day; This is a spontaneous report from a contactable other health professional, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 26Jan2021 at 09:00 AM in the left arm (at the age of 67 years-old) for COVID-19 vaccination. Medical history included hypothyroidism, autoimmune disease, allergies to penicillin and many foods. Concomitant medications included etanercept (ENBREL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan potassium (LOSARTIN). The patient receive did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 09:00 AM, the patient experienced sore arm, not severe and was lethargic for a day. On 27Jan2021, the patient had loose bowels the second day after the shot and rapid heart beat for about an hour second day, but could be thyroid as well. No treatment was received for events, sore arm, lethargic, loose bowels, rapid heart beat and thyroid. The events were reported as non-serious. The clinical outcome of sore arm, lethargic, loose bowels, rapid heart beat and thyroid was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
67 2021-02-28 influenza like illness, chills, fatigue, headache Mild flu symptoms: headache, chills, fatigue, aches
67 2021-02-28 headache Multiple joints( wrists, elbows, shoulders, and hand fingers) excruciating pain, swelling with han... Read more
Multiple joints( wrists, elbows, shoulders, and hand fingers) excruciating pain, swelling with hand and shoulder movement limitation. Last two days chest discomfort with some difficulty in breathing. Last night first time developed severe skull pain at posterior area. Symptoms mainly during night time and unable to sleep due to the intensity. Treatment: Voltaren Gel 1%, Generic Mobic 7.5 mg and Sombra Warm Therapy Natural Pain Reliving Gel, Acetaminophen 500mg. Most of the symptoms have been for the last three weeks.
67 2021-02-28 throat irritation Patientreported tingling hands, face and itchy throat on the outside not on the inside. 50mg of Bena... Read more
Patientreported tingling hands, face and itchy throat on the outside not on the inside. 50mg of Benadryl was given and patient was observed for an hour and stated she felt better when she left. Patient was not driving the car.
67 2021-02-28 sleepiness, body temperature increased, fatigue, headache felt very sleepy; very tired; Headache; elevated temperature; This is a spontaneous report from a Pf... Read more
felt very sleepy; very tired; Headache; elevated temperature; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient herself) reported that a 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1283, UPC/NDC number and expiration date were unknown), via an unspecified route of administration in the left deltoid (also reported as left shoulder) on 16Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included hypertension, for which she was taking medication for it and had a torn redness on her rotator cuff; from an unknown date and unknown if ongoing. Concomitant medications included cortisone injection as she had a torn redness on her rotator cuff, as she guessed and she was taking an unspecified medication for hypertension. The patient just wanted to report that after taking the vaccine (Covid-19 Vaccine) on the 16Jan2021, she felt very sleepy and then very tired, slightly headache and she had elevated temperature. The patient further stated that she had elevated temperature and lastly, after she had the injection, she got really, really sleepy. The patient stated that before she had the injection, she had a cortisone injection, so she didn't know. The events did not require any visit to the physician office or to the emergency room. Therapeutic measures were taken as a result of felt very sleepy, very tired, headache, and elevated temperature, which included paracetamol (TYLENOL). The outcome of all the events was unknown.
67 2021-02-28 cough, headache, head discomfort not thinking straight; very very intense headache; felt an ungodly pressure in my head; My vision wa... Read more
not thinking straight; very very intense headache; felt an ungodly pressure in my head; My vision was off; foggy; confused; coughing; felt severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped; severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher you know more towards my throat; rapid heart rate, 100bpm and 102bpm and lasted for couple of days.; my head was more clear but still had some pressure and woozy; Trouble concentrating; ALT High; Test: Cholesterol; Result: Little High/Cholesterol 207 was high; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9269), via an unspecified route of administration on 07Feb2021 (at the age of 67-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Medical history included ongoing asthma, type 2 diabetes mellitus, seasonal allergy (told to take Zyrtec for seasonal allergies prophylactically). Facility in which the vaccine was received was a clinic at a high school through the local hospital. Concomitant medication included fluticasone propionate, salmeterol (WIXELA INHUB), glipizide (GLIPIZIDE). On 07Feb2021, the patient received the first dose and while walking to the observation area (about two minute after receiving the vaccine) the patient experienced very very intense headache, felt an ungodly pressure in my head, vision was off, and trouble concentrating. When she sat down got real foggy, confused and was not thinking straight, was coughing and experienced severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped. Patient began taking deep breath. It went back over to left side of my chest and the tightness (stayed in my left chest for probably 3 days but not to the same degree). The fogginess and the intense pressure in my head, it was bad to the point she thought she would not be able to drive home, waiting for 30 minutes, and because she was not thinking clearly she didn't even ask anybody for help. When she got to the car she waited 15 minutes more before driving home. Patient stayed like this for 2 days. When she reached home, she experienced a rapid heart rate, 100bpm and 102bpm and lasted for couple of days. Each day got gradually better, her head was clearer but still had some pressure and woozy. The patient did visit the physician, he did an EKG and other test. The doctor did not think what I had was an anaphylaxis reaction. Physician recommended she make sure to take her inhalers, for asthma and told me to take Zyrtec (for seasonal allergies) ahead of time. Consumer inquired if she should receive the second dose. The patient underwent lab tests and procedures which included blood cholesterol: little high 207 on Feb2021, blood thyroid stimulating hormone: normal on Feb2021, electrocardiogram: normal on Feb2021, full blood count: normal on Feb2021, hemoglobin: 6.9 on Feb2021, heart rate: 100 bpm on Feb2021, heart rate: 102 bpm on Feb2021, metabolic function test: Alt high on Feb2021. No treatment was given for the events. The clinical outcome of the events not thinking straight, pressure in my head, foggy, confused, coughing, tightness in the left side of my chest , it then moved to the center of my chest then moved up towards throat, rapid heart rate, Woozy, intense headache, vision was off and trouble concentrating was recovering while ALT High, and Cholesterol; Result: Little High was unknown.
67 2021-03-02 chills, fever, influenza like illness, fatigue After my second injection, I , the day after, had severe flu like conditions, aches, chills, feveris... Read more
After my second injection, I , the day after, had severe flu like conditions, aches, chills, feverish, extreme fatigue. The second day after my reaction, two days after I received it, I had so much fatigue that I could do nothing, but lie in bed. The third day, I felt a little better but was again fatigued and could not do anything but rest. I began to feel a little better after the third day but two weeks later I still have fatigue but can still function. The Saturday after I received the injection on Sunday I slept 11 hours.
67 2021-03-02 fever, influenza like illness, chills Chills, fever, body aches, nausea, diarrhea, dizziness, feels like I have the flu
67 2021-03-02 nasopharyngitis, chills Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the... Read more
Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the muscle goes jumping up and down; Not feeling well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL9262 expiry date not reported, via an unspecified route of administration from 28Jan2021 at single dose for COVID-19 Immunization. Medical history included High blood pressure and Pre-diabetic. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 12.5 mg, metformin (METFORMIN) 1000 mg, twice a day, lisinopril (LISINOPRIL) 20 mg at night, pravastatin (PRAVASTATIN) 20 mg, acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (ATROSTAT). The patient experienced joint pain, not feeling well and muscle stagnant; where they gave me the shot the muscle goes jumping up and down all on 29Jan2021 and chills, injection site pain, flu and cold all on unspecified date. Consumer stated, "I am having a joint pain and chills and not feeling well, I had it Thursday evening, I took it Thursday evening. I am not feeling well from that Friday night and last night I mean the joint pain, the muscle pain you know, it's just you have to deal with." Consumer added, "I have been taking pain medicines, Ibuprofen and Tramadol for pain and Mucinex for cold and flu." Therapeutic measures were taken as a result of joint pain, injection site pain, flu and cold. Outcome of the events was unknown.
67 2021-03-02 headache, fatigue Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I cou... Read more
Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I could not sleep; Extreme fatigue; Slight headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (brand=PFIZER), via an unspecified route of administration (vaccine location=right arm) on 28Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included breast cancer and mitral valve prolapse. She had no known allergies. Concomitant medications included celecoxib (CELEBREX). No other vaccine in four weeks. No covid prior vaccination. The patient experienced heart palpitations on 28Jan2021 10:00 PM to the point where she could not sleep - started 6-8 hours after receiving vaccine. Some better the next day but still having palpitations. Day 2 after vaccine about the same. Extreme fatigue, slight headache & sore arm but not too bad on an unspecified date in 2021. No treatment received for the events. No covid test post vaccination. The patient was recovering from heart palpitations to the point where I could not sleep while outcome of other events was unknown. Information on the lot/batch number has been requested.
67 2021-03-02 fatigue Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5... Read more
Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5 days
67 2021-03-02 headache face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a c... Read more
face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a contactable consumer reported for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 16Feb2021 10:15 (at the age of 67-year-old) from lot # EN6200 at single dose for COVID-19 immunization via intramuscular route at the left arm. The caller stated she had a half an hour of sitting afterwards and then they let her go. Concomitant medications included loratadine (CLARITIN) for sinusitis and insulin for Type 2 diabetes mellitus. Relevant medical history included type 2 diabetic (Diagnosed about 17 years ago), allergic to some food, allergic to sulfa, she had a number of allergies and she had an anaphylactic reactions in the past, asthma diagnosed around the age of 40, sinuses, high blood pressure after a D&C, she had a miscarriage, uterine dilation and curettage, one headache before this in her entire life. The patient had received Flu vaccine on unknown date. The patient, on 16Feb2021 had headache that lasted for 5 minutes. It was right after the first shot of the Pfizer COVID-19 vaccine, her face went numb and she couldn't breathe through her nose. She was only able to breathe through her mouth. Her jaw got really numb. It happened when she was driving home from the vaccination center and she had to pull over because she might go into an accident. She wasn't sure if she was having a stroke or not but she was scared since her sister had histories of multiple strokes. She wanted to know Pfizer's recommendations for the second dose considering her adverse events. He had a really short headache tonight, He stated "it hit me out of the blue right in my temporal; I got on the floor it was so bad. 5 minutes after I left my face went totally numb" She stated she also had the second headache she had ever had in her entire life. She also mentioned she had some swelling in her arm but she didn't think that was unusual. She clarified as she was driving home after receiving her shot, her entire face went numb and her jawline went numb. It scared her so bad. She thought she was having a stroke or something. She confirmed she recovered completely from this, the numbness cleared up in 10 minutes. The Outcome of the event swelling arm was unknown while the outcome of the other events was recovered on 16Feb2021.
67 2021-03-02 fatigue, headache, malaise injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph no... Read more
injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph nodes under left arm; achy; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old non-pregnant female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 at 09:30 AM, in left arm, for COVID-19 immunisation. Medical history included allergies to sulfa and COVID before vaccination. Concomitant medications included calcium, glucosamine/chondroitin and unspecified multivitamin. On 30Jan2021 at 16:00 the patient experienced injection site pain, headache, joint pain, nausea, feeling unwell, tiredness, swollen lymph nodes under left arm and achy. The events got progressively worse the following day. On 01Feb2021 the patient was too tired and achy to go to work. The events did not require any treatment and were resolving at the time of report. COVID was not tested post vaccination. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
67 2021-03-02 throat pain throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (... Read more
throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: unknown) via an unspecified route of administration on the left deltoid, on 27Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetic for at least 15 years. There were no concomitant medications and no prior vaccinations within 4 weeks. On 28Jan2021, patient got a migraine and on 29Jan2021, the vomiting started which was so bad her throat was still sore. The migraine resolved as of the morning of 01Feb2021. The vomiting lasted 3-4 hours and resolved the same day (29Jan2021). It was done at a clinic at a local church. There were no treatment, she just waited it out and rehydrated. Outcome of the event throat was still sore was not recovered.
67 2021-03-03 chills, fever 3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded... Read more
3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded range between 59 and 166. 3/4 - itchy rash near injection site ( have photo)
67 2021-03-03 chills, fever, runny nose, headache, sweating Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and ... Read more
Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation. Medical history included diabetes mellitus. The patient's concomitant medications were not reported. The patient experienced positive for covid and negative for the antibodies on 02Feb2021, chills, headache, severe sweats, nausea, runny nose, fever, vomiting on an unspecified date. The outcome of events was unknown. Information about lot/batch number has been requested.
67 2021-03-03 throat irritation, fatigue, sweating Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (t... Read more
Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (the same as when I have had radioactive dye), during my 15 minutes of observation my hands and feet were cold and sweaty and I felt a little shaky. I waited 20 minutes and went to the restroom and had diarrhea (very rare for me). I went to my car and looked in the mirror and my face was bright red and the whites of my eyes were red and my eyes were glassy. I went back in to the observation area and was given oral Benadryl. and monitored for 45 minutes. Right after I took the Benadryl my throat felt itchy (not sore - itchy). My blood pressure was 157/62 when I first sat down but came down to 130/ 60 by the time I was sent home. My bp is normally about 106/60. I was really tired at home for the rest of the day so went to be early. The next day I felt fine and my arm was only slightly sore. The doctor at the immunization clinic told me not to get the 2nd shot. I called my GP, and he too told me not to get the 2nd COVID shot and wait until more information has come out about adverse reactions to the vaccine. I did not have any difficulty breathing. I don 't know if the redness on my face went down my neck to my chest. I didn't look. I did not have a fever.
67 2021-03-03 fatigue Severe pain in hands and knees where I have arthritis, tiredness low. Grade temp fluid retention doe... Read more
Severe pain in hands and knees where I have arthritis, tiredness low. Grade temp fluid retention doesn?t go down,
67 2021-03-03 fever, chills Shot in left arm. No side effects until three days later began having nausea, fever, chills, aches.... Read more
Shot in left arm. No side effects until three days later began having nausea, fever, chills, aches. Next day noticed heat, redness, increased swelling, tenderness of RIGHT arm that has Lymphedema. Called doctor today and was prescribed Keflex 500 4x a day for 7 days for suspected cellulitis.
67 2021-03-03 chills, headache, malaise, fever Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes a... Read more
Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes after the jab, I broke out in hives on my upper thigh and stomach. By 7 PM, I felt really sick, my arm felt as though the strongest person in the world punched me, and by 8, I was shivering and wrapped in a ton of blankets, by 10, every muscle in my body ached beyond its capacity and my fever was 101.8. It got to 102.1. My head was weighed down with an unrelenting headache. Finally, an hour ago, my fever broke. I have Systemic Lupus and CRPS and do not vaccinate because my body is always attacking itself. But this year I got my first ever flu vaccine. Same results. So sick.
67 2021-03-03 fever, fatigue fever - lasted one day fatigue persistent strange (flowery) taste and smell
67 2021-03-03 fever, cough, headache low grade fever (99.4F); really bad headache with aches all over/aching all over; feeling like she h... Read more
low grade fever (99.4F); really bad headache with aches all over/aching all over; feeling like she had been run over by a truck; really bad headache with aches all over/head has been hurting really bad; cough; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date: unknown) at vaccination age of 67-year-old via an unspecified route of administration in the left arm on 29Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included blood pressure (blood pressure abnormal), cholesterol (blood cholesterol) and several bypass surgeries. She mentioned that she was pretty healthy for her age. Family history included father died of heart disease and her sister has heart disease. Concomitant medication included unspecified blood pressure and cholesterol medication. The patient has no previous vaccination within 4 weeks and did have other vaccines given on the same day. The patient reported that she did not feel bad on the first day, but she started getting a cough on Saturday night (30Jan2021) and on Sunday (31Jan2021), she started getting a really bad headache with aches all over. This morning (02Feb2021), she is running a low-grade fever (99.4F). She added that now she was sick, she has a low-grade fever, chills, is hurting all over, all the things on the list. She inquired if these are common side effects of the vaccine and was asking if she should get tested to see if she's diagnosed with COVID-19. She inquired will her getting the shot effect the results of the COVID test, would she test positive for COVID now that she's had the shot. It is confirmed she has not tested positive for COVID. She did have 2 tests previously in Dec2020 before and after traveling. She further explained that she didn't feel bad until Saturday night and that is when she started with nagging cough. The aching all over started on Sunday (31Jan2021), feeling like she had been run over by a truck. She hadn't had a fever until this morning (02Feb2021), she woke up with a low-grade temperature of 99.4. She has been taking acetaminophen (TYLENOL) that helps. The call also notes later in the call that her head has been hurting really bad and this started yesterday (01Feb2021 [also reported as 31Jan2021]). It is remarked that she will probably be tested if the vaccine doesn't affect the results. The adverse events did not require emergency room or physician office. The outcome of the events was not recovered.
67 2021-03-03 sweating pt felt dizzy, diaphoretic.
67 2021-03-04 fever Continuous low grade fever since injection
67 2021-03-04 fever, fatigue, headache Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1... Read more
Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1 am on 3/5/21. Fever has dropped to 100 as of 4 pm. Severe headache persists. Advil every 6-7 hours, fluids regularly
67 2021-03-04 chills, fatigue Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was v... Read more
Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was very sore swollen some at injection site, however, I had swelling under my armpit that was very tender and sore to touch. These symptoms lasted for 2 days, the armpit tenderness lasted for 4 days. I could t keep my blood sugar levels low, as they remained high almost 400. I was taking additional insulin to try and bring it down and I wasn?t eating.
67 2021-03-04 headache, chills, body temperature increased, influenza like illness achy flu like symptoms, bad headache, chills temp 101-103.6
67 2021-03-04 chills elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; ... Read more
elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 67-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el 3247), via an unspecified route of administration on the left arm on 28Jan2021 10:15 at a single dose (at the age of 67-years-old) for COVID-19 immunization. The patient was administered in a public health clinic/administration facility. Medical history included asthma, diabetes, high blood pressure and anxiety. The patient had unspecified concomitant therapy. The patient preciously took enalapril and sulfur and experienced drug allergies: "Allergies to medications, food, or other products: Sulfur, Enalapril". The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 at 21:30, the patient experienced severe abdomen pain, abdomen swelling, chills, nausea, vomiting and elevated transaminase measurement. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received unspecified treatment for the adverse events. The patient underwent lab tests and procedures in 2021 which included CT scan, comprehensive metabolic, Random amplification of polymorphic DNA (Rapd) and ultrasound all with unknown results; on 30Jan2021 elevated transaminase; and on 31Jan2021 a negative nasal swab (SARS-CoV-2 test). The events were considered non-serious by the reporter: not resulted in death, not life threatening, did not cause or prolong hospital, not disabling/incapacitating and not a congenital anomaly/birth defect. The patient has not recovered from the events.
67 2021-03-07 headache, malaise, chills, fatigue Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/... Read more
Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/labored breathing; tightness in the chest/chest felt tight there was a heaviness just like a feeling of discomfort; joint pain started in her right elbow, right thumb, right knee, left ankle and left instep; Feeling unwell; Muscle pain; Injection site pain; Headache; has not felt normal; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), intramuscularly on 22Jan2021 09:35 at 0.3 ml single dose for COVID-19 immunization. Medical history included ongoing High cholesterol, allergies to penicillin and sulfanized antibiotics, allergies to latex, Shingles since 2007, post herpetic neuralgia, mild shingles pain from the neuralgia, changes in temperature, the temperature and the weather going up and down. No other condition was reported. Concomitant medication included rosuvastatin (strength: 10mg) from 18Jan2021 to 24Jan2021 at 10 mg for High cholesterol. Past drug event included doxycycline allergy (she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP and unable to sleep), Ibuprofen allergy, Levaquin allergy, Valium allergy and omeprazole allergy, took sulfanized (SULFA) antibiotics allergy (she had rapid heartbeat, sweating). Patient stated she said that she had received the first dose of the COVID-19 vaccine and did experience some side effects of the COVID-19 vaccine. She said she did not have an anaphylactic reaction but had difficulty in breathing 2 days after having the first dose. She said she experienced 30 hours of labored breathing. She wanted to know if there is "sulfa dioxide" in the lipid/mRNA portion of the COVID-19 vaccine. She said she is highly allergic to "sulfanized compounds". She is also allergic to all forms of penicillins. Caller wanted to know if the second dose of the vaccine has the same ingredients as the first dose. She wanted to know if the ingredients have the same amounts as the first dose or if the actives are stronger. She based this question from "most people having more reaction on the second dose of the vaccine" and also from what Pfizer second line told her "the first dose primes the system while the second dose strengthens the system". She wanted to know what ingredient causes the anaphylactic reactions for this vaccine and if it is penicillin. On 22Jan2021 she learned that there is a small amount of Sulfa Dioxide in the lipid portion of mRNA and she is highly allergic to sulfa compounds. With her side effects she would also like to add that she had a severe case of shingles in 2007 that was not diagnosed until the end of the 7th week. She had seen 8 doctors, her family doctor, she had 3 ER visits so prior to the vaccine she had post herpetic neuralgia and so a week and half before the vaccine there were changes in temperature, the temperature and the weather going up and down so she was having mild shingles pain from the neuralgia going into the vaccine which was given on 22Jan2021. The other thing is she had high cholesterol and her cardiologist put her on a statin she does not have high BP but she has high cholesterol so she was started on a statin, it was Crestor 10 mg, actually it says it is Rosuvastatin Calcium 10 mg and she took that 18Jan2021 and the 19Jan2021 and then on the 20Jan2021 her doctor told her to stop it before her vaccine so she did and she felt okay just had mild reactions so she took the Rosuvastatin that Friday night 22Jan2021 and she took it 23Jan2021 then she took her self-off of it on 24Jan2021. She called her doctor on 25Jan2021 and he said yes stop the Rosuvastatin and stay off it until after your second dose of the vaccine. So she was having an allergic reaction in Jan2021 she has had a lot of side effects from being post shingles and all the side effects from COVID vaccine and being post shingles and the statin all of the possible side effects mirror one another. As far as the reaction she got a headache about 35 minutes after she took the shot Friday morning at about 9:35 AM and she took Tylenol twice that day, once that morning and she took it also around 4:30 PM when she was having medium pain at the injection site and that is when she took her statin and she woke up on 23Jan2021 and until late in the afternoon she had tightness in the chest so she took one more Tylenol then that was mid-morning, so total she had 3 doses of 325 mg Tylenol. Then on 24Jan2021 at about 4:30 AM in the morning she woke up with labored breathing, it wasn't normal. She did not have a closed throat but her breathing was labored, her chest felt tight there was a heaviness just like a feeling of discomfort. Then around 5 pm that same day the joint pain started in her right elbow, right thumb, right knee, left ankle and left instep and the pain wasn't constant it was jumping to different parts of her body and she still felt the tightness in her chest and heaviness all day. Then around 4PM on 24Jan2021, Saturday the labored breathing dissipated around 8pm and she did not take the statin that night then on 25Jan2021 her breathing was normal but she still had tightness in her chest. She had injection site pain on the 22Jan2021, 23Jan2021 and the 24Jan2021 and it was almost totally gone on 25Jan2021. Tiredness began on the evening 22Jan2021 the day she had the shot and it comes and goes. Headache- she had mild headache and she had took Tylenol so it was mitigated a little but it started 22Jan2021 and she had a headache through the 23Jan2021, 24Jan2021 and the 27Jan2021 so around 3:25PM yesterday she took another Tylenol yesterday 27Jan2021. Muscle pain she has had since 23Jan2021 and it has been ongoing but less today, she doesn't know if it will come back or not. It is mainly in the in the rhomboids which is the shoulder wings. She had it on both sides. Chills she had 25Jan2021, 26Jan2021 and 27Jan2021 and they come on mid-day-late afternoon they go on up until early evening, a little past supper/dinner time. Joint pain was 23Jan2021, 24Jan2021, 27Jan2021 and pain in her rhomboid muscles. She has had no fever, no swelling or redness at the injection site, no nausea. Feeling unwell- she would say from 23Jan2021 to the present she has not felt normal on 22Jan2021, it comes and goes She has not had swollen lymph nodes. Difficulty breathing 24Jan2021 at 4:30 am it woke her up and she had labored breathing, no closed throat and she stopped the Statin that day, tightness in her chest started 24Jan2021 in the morning and she had that 25Jan2021 26Jan2021 and it has been present on and off mainly in her back discomfort. She says the tightness is not really in the front around the heart but it is like a total tightness in the chest area. Muscle pain on the 27Jan2021 mainly in her back, the rhomboids. Fast heartbeat- She was sound sleep this morning at about 12:45AM and it woke her up her heartrate was 87, her BP was 135/81 (2021) and she did an ice pack for 16 minutes on her head and then she went back to sleep at 4:45 AM she woke up again her BP 131/87 pulse was 80 temp was 97.8 (2021). She didn't take her temp the first time she woke up she just did an ice pack for 16 minutes and she as up for a while typing side effects at that point. Then she went back to sleep from 6:20-7:20 and then when she woke up again her BP was 122/75 and pulse was 64, temp 98.3 (2021). For someone look at at her BP they may say that's not high but for someone post shingles, the pain, the nerve endings are already on edge she can feel it working on her body. They say reactions are proof that the vaccine is working but her issue with the joint pain, it disappeared when she stopped the Statin and then there is the labored breathing, she has had 2 new drugs that went into her system at the same time and she doesn't know, one has the documented side effects and the other one it is so unknown at least the mRNA part she does not know if she is just having a reaction to Sulfa. She says that blood pressure doesn't seem high but for someone whose body is stressed and with her pulse to go up when she is sound asleep, normally when her body is sleeping and she wakes up she would be about 117/70 (2021), she would have low numbers she doesn't have high BP. She took the statin for 2-3 days and then stopped it her doctor told her she could start and stop it and her doctor told her to stay off of it but she started it because she felt okay she only had a headache and injection pain so she said she is going to take it and then things intensified so she decided to stay off it. She has a history of having delayed serious side effects. She is allergic also to Penicillin and that is probably in the records already because she called and asked when she was thinking about taking it. It dates way back with her allergies with her, it is extensive Doxycycline, Ibuprofen, Levaquin, all forms of Penicillin, sulfanized antibiotics, Valium, latex, Omeprazole. She had shingles so bad after about 7.5 weeks of it going undiagnosed she had the 2 worse reaction and they asked her they went through her history and asked what are the 2 worst things she had and that was with Doxycycline they gave her that because they thought she had a bacterial infection and didn't realize it was shingles and she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP she was unable to sleep literally she could feel the blood coursing through her veins. and then the other one she knows is Sulfa she has had that allergy since a child but she had rapid heart beat, sweating and there may have been other symptoms but she does not remember she was a child. She has been given Sulfa drugs since then and she is highly sensitive to Sulfa. Outcome of the event muscle pain was not recovered; injection site pain was recovered on 25Jan2021; labored breathing was recovered on 24Jan2021, while other events was unknown. No follow-up attempts are possible. No further information is expected.
67 2021-03-08 headache, throat irritation, runny nose, fever Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremi... Read more
Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremities started stinging, nose running & feeling feverish. My ears started ringing too & got vertigo. Also I started having trouble breathing with a slight ache/pain in my lungs. A noticible itch started in my nose & a tickle in my throat and I had extreme muscle pain, especially in extremities affected by previous carpal tunnel injuries & sciatica. Tuesday afternoon all symptoms were worsening so I used Zicam Gel swabs in my nose, made chicken garlic soup & tea with honey & went to bed. It took 3 days for the sinus, headache & respiratory symptoms to resolve. The neuropathy (skin stinging) pain in my arms, hands & lower legs persists and is very painful.
67 2021-03-09 fever, chills, fatigue, headache bone ache; body shaking chills; no appetite; exhaustion; headache; occasional nausea; incapacitating... Read more
bone ache; body shaking chills; no appetite; exhaustion; headache; occasional nausea; incapacitating fever; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9265), dose 2 , single dose via an unspecified route of administration in the left arm on 02Feb2021 at 14:00 (at the age of 67 years-old) for COVID-19 vaccination. The patient was not pregnant. Medical history included primary immunodeficiency, diabetes, irritable bowel disease, gastroesophageal reflux disease (GERD), high cholesterol and allergy to cefazolin (ANCEF). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248, dose 1 on 12Jan2021 at 2:15 PM in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included famotidine, lansoprazole, pioglitazone and rosuvastatin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 03Feb2021 at 09:00 AM, the patient experienced bone ache, body shaking chills, no appetite, exhaustion, headache, occasional nausea and incapacitating fever. Treatment was not received for the events. The clinical outcome of bone ache, body shaking chills, no appetite, exhaustion, headache, occasional nausea and incapacitating fever was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
67 2021-03-10 headache On 3/4 patient received 1st dose of COVID vaccination. She states that she drove home afterward and ... Read more
On 3/4 patient received 1st dose of COVID vaccination. She states that she drove home afterward and decided to sit and watch TV. She immediately began noticing that the words on her TV screen were not legible - her vision had become blurry. This blurriness was accompanied by severe eye pain and pain in the temples of her head. When shutting eyes and keeping them closed for a few hours, the blurriness would subside. However she continues to experience this blurriness 'on and off' to date. Also experienced some mild headaches but they have subsided as of two days ago. Hasn't taken anything to alleviate the symptoms. Patient is extremely concerned that she may permanently lose vision and refuses to get 2nd dose.
67 2021-03-10 throat irritation, chills syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills... Read more
syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills; mild pain at injection site; This is a spontaneous report from a contactable pharmacist reported for self. This 67-year-old female patient (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 13:45 PM on Arm left via Intramuscular at single dose (Lot # EL9269) for covid-19 immunisation. Medical history included Osteoporosis, known allergies: Sulfa, flu vaccine for immunisation. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), ergocalciferol (VITAMIN D), calcium, magnesium, biotin, bifidobacterium lactis (PROBIOTIC). No other vaccine in four weeks. Past similar reaction from Flu vaccine 8 years ago (2013) for immunisation and treated in ED, had no problems with any other vaccine such as HepB (Hepatitis B), DTAP, pneumococcal 23, Shingrix all for immunization. On 17Feb2021 14:15 PM, feeling of heat rising into throat, then lightheaded- EMT on-site monitored BP, heart, oxygen then administered IV Benadryl and zofran - signed out in 2hr, developed chills and syncope for next 4 days and mild pain at injection site. Self treated with Tylenol/ advised by MD to not get 2nd dose. Events resulted in emergency room/department or urgent care. Treatments were received for the events. Treatment included IV Benadryl and IV Zofran. Outcome of the events was recovering.; Sender's Comments: Based on a temporal association, a causal relationship between the events of feeling of heat rising into throat, lightheaded and syncope, and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-03-13 fever, headache 3/9/21 PM headache, 3/10/21 AM fever, generalized achiness, 3/11/21 bilateral hand swelling and rash... Read more
3/9/21 PM headache, 3/10/21 AM fever, generalized achiness, 3/11/21 bilateral hand swelling and rash on hands, diffuse itching. 3/14/21AM swelling around eyes. continues itching. continued fever. swelling in hands improved.
67 2021-03-14 headache Abdominal cramps/really bad cramps in my abdomen; a bit of a headache; This is a spontaneous report ... Read more
Abdominal cramps/really bad cramps in my abdomen; a bit of a headache; This is a spontaneous report from a consumer. A 67-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no:EN9581, expiration date:31May2021) as first dose, on left arm, via an unspecified route of administration on 28Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included Kidney transplant recipient from 1995 and ongoing. There were no concomitant medications was not reported. This consumer reported that she was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine 28Jan2021 about 15:30. On 28Jan2021 about 19:30 she had onset of abdominal cramps. Patient also reported that she received the Pfizer shot yesterday at around 3:30, then at around 7:30 she experienced really bad cramps in her abdomen, along with a bit of a headache. She asked if that is one of the side effects of the Pfizer-BioNTech COVID-19 Vaccine. She was a little concerned because she heard that if you had a reaction or side effects to the first dose of the Pfizer-BioNTech COVID-19 Vaccine that they would be worse with the second dose. She had abdominal cramps all night long off and on. She reported outcome as ongoing but a little bit better. She did better if she just stays still. When she gets up and starts doing things the abdominal cramps occur more. She described the abdominal cramps as being kind of like menstrual cramps, which she has not had in a long time, but they are low like that in the abdomen; not like stomach cramps that are up higher. Usually with something like this kind of abdominal cramps she would have diarrhea but she was not having any diarrhea. The abdominal cramps are weird feeling. Outcome of the event abdominal cramps/really bad cramps in my abdomen was recovering and outcome of other event was unknown.
67 2021-03-14 fever, malaise, headache My arm did get sore and it had stayed sore; I am also experiencing nausea; headache; not feeling wel... Read more
My arm did get sore and it had stayed sore; I am also experiencing nausea; headache; not feeling well; felt feverish; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on her arm on 25Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included raynaud's phenomenon. She was told that she could not donate plasma because of it but she have raynauds, she stated she is not taking medications or anything for it, it's just she get chills in her hands and feet from anything if she drink anything cold or get chilled or whatever, white they turn white. It was reported that patient had Covid 19 and was tested positive for antibodies back in June. The patient's concomitant medications included estradiol (Cream, its a hormone cream), vaginally at 13 micro grams, twice a week for unknown indication and acyclovir for unknown indication. In Jan2021, patient reported that her arm did get sore and it had stayed sore and she is also experiencing nausea, she had experienced nausea that night, a headache, not feeling well and felt feverish didn't recorded fever but her concern is that it's not going away. The patient received treatment just advil (as reported). The events were considered as non-serious. The outcome of the event felt feverish was not recovered and outcome of other events unknown.
67 2021-03-14 sweating, chills Vomiting; Diarrhea; Sweating and shivering all night; Sweating and shivering all night; This is a sp... Read more
Vomiting; Diarrhea; Sweating and shivering all night; Sweating and shivering all night; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL1283) in the left arm, at single dose, on 03Feb2021 at 07:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included hypertension. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. The patient previously, on 12Jan2021, at 07:00 AM, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK9231) in the left arm, for COVID-19 immunisation. Concomitant medications included metoprolol, simvastatin, telmisartan and buspirone hydrochloride (BUSPAR). On 05Feb2021, at 10:00 PM, the patient experienced vomiting and diarrhea, sweating and shivering all night. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received. The patient recovered from the events on an unspecified date.
67 2021-03-14 chills, headache nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontan... Read more
nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E1823886, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 10:00 (age at the time of vaccination was 67-year-old) on right arm at single dose for covid-19 immunisation. Medical history included allergy to Sulfa. Concomitant medication patient received within 2 weeks of vaccination included Hydrochloride, potassium chloride (K-DUR), vitamin d3, irbesartin. The patient experienced nausea, dizzy, chills, body aches, headache, trouble concentrating and very sore arm on 09Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events.
67 2021-03-15 fatigue Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and i... Read more
Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and it felt heavy and it just dropped. She then started to raise the arm and she was not able to do it. She then suddenly lost sensation in her left arm. She then could not control it, would raise when it wanted to but was not able to feel it or control it. (had the feeling that it was not connected to her body and it was just floating around). Then started having involuntary muscle spasms in her mid torso region. The same thing then happened again and the muscle spasms were more intense and she waited around and lasted for minutes. She never lost consciousness, but then it happened again and was spreading on her left side. It then encompassed from her hip up to her shoulder. The involuntary muscle spasms were moving from the side toward her chest to where she felt it would impact her breathing. She then went to the ER and they started doing testing, and she had more spasms, and then started having double vision. In talking with the doctor about all of this she had a CVA with complex partial epilepsy with recurrent seizures and that the double vision was related to the infarct in her brain and that the stroke triggered the seizure that she had. She did not lose any memory, loss of consciousness, no weakness or loss of sensation. These episodes only lasted minutes and a refractory time of minutes and when she got to the ER she the other episode when they were trying to test her. They were not able to do the EKG or EEG due to the involuntary movements and these resolved. She is now completely recovered other than the fatigue with no residual. She saw a neurologist on 2/24/21 who felt like that she had a stroke and put her on Keppra and is going to FU in 3 months at IU. It was ruled out that there was no relationship of her transplant to this reaction. She is now on Keppra, Atorvastatin for the swelling in her brain, and also put on aspirin 81 mg. Her blood tests that were done were all drawn and were all within normal limits except for kidney function, but is only a minor #'s for her secondary to the transplant. She then had some titers drawn for CMV and that was also negative. Then she had a COVID test that was negative. Then she had spinal tap that came back normal results.
67 2021-03-15 fever Nausea; Diarrhea; Fever; This is a spontaneous report from a contactable consumer (patient). A 67-ye... Read more
Nausea; Diarrhea; Fever; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9810), via an unspecified route of administration on 05Feb2021 at a single dose on left arm for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient was asking if Pfizer had people, about 3 or 4 days later, get nausea and diarrhea after getting the COVID shot. She had a real bad fever 3 hours after the shot but felt fine the next day. But now she has nausea and diarrhea that started yesterday (08Feb2021). She normally does not that have that. Her nausea has improved because she took a nausea pill, ondansetron (ZOFRAN) 2 mg. Therapeutic measures were taken as a result of nausea. The outcome of the event fever was recovered on 06Feb2021, nausea was recovering, and diarrhea was recovered on 09Feb2021.
67 2021-03-17 headache My face went numb; Headache; This is a spontaneous report from a contactable consumer. A 67-years-o... Read more
My face went numb; Headache; This is a spontaneous report from a contactable consumer. A 67-years-old non-pregnant female patient received BNT162b2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, in the left arm, on16Feb2021 at 10:15 (at the age of 67 years-old) as a single dose for covid-19 immunisation. Medical history included headache, anaphylaxis reactions to food allergies, Spinich, cabbage, sulfa based drugs diabetes, and asthma. The patient had not received any other vaccinations within 4 weeks and was not diagnosed with COVID-19. Concomitant medication included diabetes meds and insulin glargine (BASAGLAR). The patient reported on 16Feb2021, at 10:45 after waiting 30 as instructed, I had a reaction 5 - 10 minutes later. My face went numb, and then a headache started. I have had only 1headache in my life prior to this. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the event was recovered
67 2021-03-18 fatigue, headache Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her a... Read more
Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her appetite; heard in the background stating the COVID-19 Vaccine screwed up her mind; Headache; Eyes hurt/Her eyes felt like they were going to pop out; Feels tired and weak; Feels tired and weak; can't think straight; pain in head and stomach; change of mood; altered mental status and nightmares; altered mental status and nightmares; she is so mean to everybody / not acting normal; her eyes felt like they were going to pop out; Suicidal thoughts/thinking of committing suicide; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL267, expiry date 31May2021) via an unspecified route of administration, at the age of 67-year-old, on 24Feb2021, as SINGLE DOSE (0.3mi as reported) for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and ongoing allergy to penicillin. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9265, expiry date 31May2021) via an unspecified route of administration, on 03Feb2021, single dose for covid-19 immunisation wherein the patient had to got to Emergency room and it was found that her magnesium and potassium were low. The patient had a super bad reaction to the Pfizer vaccine. Patient's mind has not been normal ever since and she is so mean to everybody. The patient was fine until she got the vaccine. The reporter has had the ambulance and police up there to try and help but the caller wouldn't go out to the hospital. The patient had a normal mind before she got the shot. The patient has a bad headache that will not go away (8 days) and her eyes are hurting really bad/eye pain/ eyes hurt. She feels so tired and weak. The second COVID-19 Vaccine messed the patient up. She had the same symptoms for both first and second dose (unspecified symptoms), but the second dose has really messed up her mind. Patient probably won't have a mind. It was reported that the patient's mind was alright, but the second COVID-19 Vaccine did her in. Now patient is saying she won't get her mind back. It has messed up her mind. Clarified when caller states it messed up her mind, he is referring to the patient being mean. Stated patient did have a headache, but wasn't hateful. Stated patient's mind is so bad, she is just mean. If patient doesn't get help soon she is going to tell herself good night. Patient stated in background "If I don't get my mind back I'm going to end up killing myself because he made me." At 11PM last Wednesday (24Feb2021), patient starting losing her mind. Confirmed with caller that patient is currently having suicidal thoughts. Patient used to be a real nice lady and blames this on the COVID-19 Vaccine. Patient is afraid she is not going to get her mind back. Advised caller to seek emergent medical attention for the patient. Patient is against everybody now because of the crazy COVID-19 Vaccine. Patient heard in the background stating the COVID-19 Vaccine screwed up her mind. Caller stated patient is quite upset with everybody. Patient is not acting normal. Patient doesn't think her mind will ever get straightened. The medicine was too much for her body. After getting the second dose, the patient lost her mind, she's lost her appetite/ No appetite and went 32 hours without eating, can't think straight, altered state of mental, mental fog, pain in head and stomach, change of mood, nightmares, her eyes felt like they were going to pop out. Her doctor said it was probably an overdose. The patient was not like this prior to second dose. Outcome of the event was unknown. The reporter believes her mental fog is due to second dose of vaccine.
67 2021-03-18 fatigue Patient is being hospitalized for COVID-19 pneumonia. The patient has had a pulse ox reading in the ... Read more
Patient is being hospitalized for COVID-19 pneumonia. The patient has had a pulse ox reading in the low 90s and feels short of breath. She had a positive COVID-19 test collected on 3/16/21. She has fatigue and nausea/vomiting. The patient received Regeneron antibody infusion and dexamethasone. In ED, patient is requiring 2 L of O2 to maintain O2 saturation of 96%. Patient is being admitted.
67 2021-03-18 fatigue, chills Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; F... Read more
Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; Freezing and chills; Felt like would pass out/felt so faint; Ate dinner but food came back up; Shortness of breath; Cheeks flushed; Achy; felt draggy/feeling tired; This is a spontaneous report from a contactable. A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: GL9266, via an unspecified route of administration, administered in left arm on 21Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatic fever (occurred age 7), vulvovaginal dryness and sore joints. The patient was negative on Covid test on an unspecified date. Historical vaccine included BNT162B2 on 28Jan2021 for COVID-19 immunisation and flu shot. Concomitant medications included estradiol (IMVEXXY) taken for vulvovaginal dryness; vitamin C [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); calcium. On Monday, 22Feb2021, the patient felt draggy, but did not think it was a big deal. She just thought it was from the shot and was feeling tired. The draggy feeling lasted a few days, but she was unable to clarify outcome further. On Tuesday, she started to feel achy and felt like that too was to be expected. The achiness went away on 25Feb2021. On Wednesday, 24Feb2021, she was really busy. She was still achy but was busy. She also did not drink much water for several hours. It dawned on her later when she was not feeling good. Late Wednesday afternoon it was like everything cratered and she felt horrible. She was feeling bad. She was freezing and had chills. It was a horrible feeling. She helps with her grandkids since she is retired. They were home from school and had to sit on the couch. She felt cold, yucky, and achy. It was a yucky feeling. She went home a couple of hours later. She told her husband she had to lie down on the couch because she felt horrible. She could not further describe horrible feeling. Her daughter had called her as well and was unable to describe how she felt to her daughter. She could only say she felt so sick but could not explain further. She felt awful and could not put her finger on it. She was laying down and when she got up, she felt like she would pass out. At that time, she had not eaten dinner yet. She ate dinner, took one bite and the food came back up. For a few moments she felt so faint, she felt shortness of breath, but it was only for a few seconds. After that, her and her and her husband took a drive to go to hospital. However, by the time she got to hospital she was feeling better. She was also talking to a friend at that time who said all of this was probably form the shot as well. Since she was feeling better decided not to go into the hospital and went back home. At the time she was thinking this was all from the shot and no big deal. On Wednesday night, things got crazy and worse. That evening Wednesday she was getting ready for bed and noticed her cheeks were flushed. On Thursday she got up and noticed rash. She was covered all over her body. It did not itchy really, but it was a rash. Not a bumpy rash, it reminds her of Roseola. Her joints and fingers were starting to swell. Her hands were swollen. It started with her knuckles, it went to her fingers, up to her hands, wrist. Her wrist was sore. Her joint swelling was worse. On Friday, she tried to see her doctor, but could not be seen by the doctor. However, she got in with the PA. When she saw the doctor, it could be seen her hands were swollen. However, the main reason she went to the doctor was due to the rash. However, her joints were sore and swollen. Treatment for rash included Hydroxyzine, for joints and fingers swollen/ wrist was soreincluded prednisone 10mg one tablet every day for five days. The patient recovered from the event felt like would pass out/felt so faint and shortness of breath on 24Feb2021. The outcome of the events joints and fingers swelling/hands were swollen, wrist was sore and cheeks flushed was not recovered.
67 2021-03-18 fatigue, headache feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nause... Read more
feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nauseous; accelerated HR; she had body shakes/body was trembling; to the point she thought she was going to pass out; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL1284) at vaccination age of 67-year-old via an unspecified route of administration on 28Jan2021 at a single dose to prevent COVID19 (covid-19 immunisation). Medical history included interstitial lung disease and overactive thyroid (She was treated for overactive thyroid, but it has been stable for five years). Concomitant medication included nitrofurantoin for interstitial lung disease and fluticasone. The patient previously took prednisone [prednisone acetate] (She did ten weeks of Prednisone and has been off Prednisone since the middle of Nov2020. She started at 30mg and tapered down to 20mg then to 10mg and then to 5mg until she was done). The patient experienced feeling lightheaded, mild headache, fatigue, erratic bp 01Feb2021 11:30, feeling nauseous on an unspecified date in 2021. Took Pfizer Covid 19 vaccine last week. Began feeling lightheaded, mild headache, fatigue, erratic BP on Monday, 4 days after receiving the vaccine. Went to Emergency department on Monday evening. Has been continuing off and on since Monday. Can these symptoms occur after 4 days patient questioned. Has already reported to DSU. She got Pfizer's COVID19 Vaccine a week ago today. She was doing fine and then Monday she started with mild headache, erratic blood pressure readings. She ended up in the ER because it was so high. It stabled out and she went home. She was feeling ok on Tuesday, but not quite normal. She was fine yesterday until last night then it started again with erratic blood pressure, fatigue, mild headache and lightheadedness. The headache is never pounding. The lightheadedness won't go away. Is that normal to have that many days after receiving the vaccine? It was four days before she started experiencing it. Now she feels kind of normal as long as she is laying down except for headache. As of 15Feb2021, the patient reported that she called a couple weeks ago and reported adverse side effects and she needed a couple questions answered. She mentioned that she was due to have the second vaccine this weeks (18Feb2021). She was extremely worried about doing it because even some of the effects she had after 4 days in the first vaccination have not subsided. She added that it landed her in emergency room a couple of times (also reported as ended up in the ER twice). She inquired if should she take the second one at this point or can she wait and if she can wait for how long. She mentioned that she had a spike in her blood pressure (BP), she had accelerated HR on an unspecified date in 2021, she was very lightheaded to the point she thought she was going to pass out on an unspecified date in 2021. The second time around, her body was trembling on an unspecified date in 2021, she had body shakes. It was not fun. All of these effects have returned to somewhat normalcy, but she is still experiencing lightheadedness. She has seen her own physicians, but she is not sure if she should proceed with the second vaccine. The outcome of the event lightheadedness was not recovered while the outcome of the other events was recovering. Follow up (15Feb2021): New information received from a contactable consumer (patient) included: lab data, new event (accelerated HR, to the point she thought she was going to pass out, body shakes/trembling) and clinical course of the events.
67 2021-03-20 fatigue Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradu... Read more
Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradually better over 45?. Tried to leave didn?t get out of bldg, collapsed in chair bad chest pain felt really bad. Ambulance called, gradually progresses to weak r side hi b/p slurred stammering speech inability to swallow tongue thrusting to Uc health ct w contrast ok. Gradually improved discharged at 1700. Saw doctor following Monday. Cardiac work up scheduled 4/5/21 She does not want 2nd vaccine until cleared by cardiologist. I have had bouts of chest pain. Hospital tadmitted me as Jane doe. Severe fatigue sleeping 12-14 h/ d for 5-6 d no fever flu sx. Low energy. Hospital never took he from me once better discharged as migraine but I don?t have migraines
67 2021-03-20 headache, chills severe headache; body pain/ aches; Chills; temperature; This is a spontaneous report from a contacta... Read more
severe headache; body pain/ aches; Chills; temperature; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: May2021), via an unspecified route of administration, in Arm Left on 04Feb2021 around 09:00 AM as SINGLE DOSE for covid-19 immunization. The patient (age was 66-year-old) first dose was LOT: EK4176 with EXP Mar2021 and was injected 14Jan2021, in her left arm around 09:00AM for covid-19 immunization. She says she did have a flu shot in Sep (unspecified year, NDC/LOT/EXP unknown). Medical history included fibromyalgia from 2009, lyme disease and Arthritis from an unknown date; all unknown if ongoing (reported as diagnosis of fibromyalgia/Lyme disease depends on what specialist she sees, but she was diagnosed first with fibromyalgia in 2009. She says that she also has severe osteoarthritis, but not the one that does the bones, just put arthritis, since it is not the type that deteriorates the bones, it does cartilage). There were no concomitant medications. The patient says she has not had any other recent vaccinations or started any new medications. It was reported by the patient, who says she had her second vaccination on 04Feb2021 and had a pretty strong reaction for about 36 hours. She says she had a severe headache, body pain, and a temperature with no chest involvement. She says she has experienced this every 3 hours for days now after, in waves. She says she would like to know if anyone else has reported a similar thing as what is happening to her. She says she goes 3-4 hours with a headache and chills today, and aches, and she didn't know if that was typical or not. She says she has not spoken to her health care provider about this. The patient reported that she got the vaccines from pharmacists that came to the care center where her mother lives. For the treatment the patient says she took Ibuprofen last night, which seemed to give her some relief. She says that the Ibuprofen (EXP Jan2022, LOT: 63650291AA, UPC: 1387402032). She says that the Ibuprofen is 200mg and she just took one dose, one time only, she tried it yesterday. She says when it started and hit again today she thought she should call someone and talk about it. The outcome of the events was unknown.
67 2021-03-21 fever Patient was hospitalized with fever, body aches, inability to transfer and SIRS. Increased liver en... Read more
Patient was hospitalized with fever, body aches, inability to transfer and SIRS. Increased liver enzymes as well
67 2021-03-22 malaise, throat pain I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269... Read more
I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269) on 2/18/21. That evening she reported not feeling "right". Over the next two days after receiving the vaccine on Thursday she reported to family that she didnt feel well. She had no fever but muscle aches, an earache and sore throat (this was on Friday and Saturday). On Sunday her breathing became a bit labored. She still had previous symptoms reported and labored breathing -- she stated she thought she would have to go to the Dr the next day (Monday, Feb 22, 201) if she did not feel better. Sometime in the night of Feb 21st and Feb 22nd my mom passed away. My mom had many health problems. Heart disease, diabetic, she was on dialysis and had sleep apnea. However, she definitely seemed to be having some difficulty with the affects of the first vaccine. Please let her life be counted.
67 2021-03-23 malaise, chills I had chills; feeling of being unwell; arm, it was swollen looked like Popeyes arm; warm to touch/ T... Read more
I had chills; feeling of being unwell; arm, it was swollen looked like Popeyes arm; warm to touch/ The arm she got the vaccine in; arm she got the vaccine in, left arm, really hurt; arm, it was swollen looked like Popeyes arm, blotches,; her adverse reaction turned out to be cellulitis/cellulitis from the injection.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration left arm on 03Mar2021 14:15 (Batch/Lot Number: EN6203),at the age of 67-years at vaccination, as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose on vaccine on 10Feb2021, LOT:EL9266 to Upper Left Arm. On 03Mar2021 at 2:15PM; patient received the second dose of the Pfizer covid vaccine, in her left arm; her adverse reaction turned out to be cellulitis, Patient states, it could have been happening two days or a day before she actually noticed it when she took off the Band-Aid, she had chills and didn't feel well on day 3 of the vaccine she still didn't feel well it was still hurting, she looked at the arm, it was swollen looked like Popeyes arm, blotches, warm to touch, she didn't have a temperature but she knew something was wrong. She got an antibiotic started from a doctor, and Famciclovir , that she took one day. She thought all of this stressed her out and she would end up with shingles. the medications are Doxycylcine, Hyclate, and Famciclovir, A doctor over the phone said that she had cellulitis, and told me to go into the ER, so early in the afternoon, she went to urgent care and they said she had cellulitis, and that's when she got the prescriptions. They wanted to see her on 07Mar2021 to check, and it is doing better. The patient was also asking, should she be somebody to get an antibody test, to see if it did it's job. Does she need to re-do the vaccine? The patient asked, was the bacteria in the vaccine or in the needle? She feel like there was something in the vaccine, maybe the bacteria was in the vaccine. LOT EN6203 - She has a Band-Aid from the site kept in a freezer at home. The vaccination Center. She stated she feel really fortunate, she was just scared to death of getting covid. For some reason, she got a bacterial infection that day, she have no way of knowing if it was the health care worker and bad technique, or bad vaccine. Psychologically, there's something about not knowing if the vaccine is protecting me because she took these medications, she was not sure I have the protection, and it creates a level of anxiety. Patient states that she believes she had an adverse reaction from her second dose on 03MAR2021. She states that three days later after the shot, she had already had chills and a feeling of being unwell. The arm she got the vaccine in, left arm, really hurt and she looked in the mirror and could see red blotches from her shoulder to the elbow and it was swollen and warm to touch. Patient states that she called around Saturday morning asking if this was typical or to be expected. She states at one point she called an ER and the doctor there said right away cellulitis and said that someone needed to see her. Patient states that she has no transportation so she had to wait until the afternoon and her son took her to Urgent care to be seen and she was diagnosed with cellulitis from the injection. The patient states she noticed when her arm felt unusual, thinks 6MAR2021. Treatment: Patient states that she was given an antibiotic, Doxycycline HYCLATE, 100mg twice a day for 7 days. She started taking it on Saturday 06Mar2021. Patient states the doctor asked her to come back the following day and looked at it again and thought it was improving and sent her home. Patient states that she also took a one day dose Samciclovir Sunday 07MAR2021. Patient clarifies that she had shingles in past and feels stress is going to cause this to occur again for her. She did take one day dose. She states that she does not have a shingles breakout nor did she have one. States that it prevents shingles breakouts and she took it as a preventative dose. Patient states the actual injection site is still warm and painful. Patient states, because she is on the antibiotic and also took the samsivocloir, a total of 2000mg, she is wondering does that make the vaccination ineffective, would she have to redo it? The outcome of the event was not recovered. Information on lot/batch is requested
67 2021-03-25 headache, influenza like illness, fatigue Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized ac... Read more
Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized aching; Fibromyalgia flare up; No energy been very tired; No energy been very tired; Felt like she was going to faint; Dizziness; Vision blurred; Loss of appetite; Flu-like symptoms; Hands feel warm to touch, but she still feels cold; She cannot sit or stand without discomfort in her spine; She cannot sit or stand without discomfort in her spine; Sick; Her bones and muscles hurt; Her bones and muscles hurt; Wheezing; This is a spontaneous report from a contactable Other HCP, the patient. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE,Lot Number: EM9809; Expiration Date: 30Jun2021), intramuscularly, on 01Mar2021 at 13:45 (at the age of 67 years old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included having become disabled in 2009, arrhythmia from 2014 and ongoing which was diagnosed after she took a Hep C treatment (Sovaldi, Ribavirin, Olysio). She had to take these medications for five months, where most people have to take it for three, ongoing allergic asthma - allergic to "everything." She has had this her whole life, diagnosed when she was 5. Started treatment with steroids at 16 , Hepatitis C from 1996 to 2014 diagnosed 4 years after blood transfusions Could have already gotten it as a nurse, was much more resistant than the average person 5 weeks to go negative, ongoing hepatic failure from 2013- she went into liver failure from Hep C. An event occurred- exposure of a deadly toxin that came from China, ongoing fibromyalgia from 1992 -Immediately after blood transfusions when her son was born- Gave her the correct blood but her body reacted. Flu shot in Early Oct2020 Fibromyalgia flare up, 4 times the dose (as reported)- Onset Age 66, Seizure disorder which was diagnosed in 2016 after disseminated shingles; after 2.5 months started having black outs where she did things and said things no memory of, the only way she knew it happened is if there were consequences. Doesn't know if she still has those, but she is getting an MRI and EEG. She lost vision in her right eye 2 years ago due to retina surgery macular pucker. She thinks her liver was stealing Vitamin A from her eye. Medical history also includes she ran over herself with her car, blood pressure abnormal, hepatic encephalopathy, autoimmune thyroiditis, and anxiety all from unknown dates and unknown if ongoing. The patient has had cataracts since an unknown date prior to the vaccination. The patient was diagnosed with "Rocky Mountain" in 2009. She also mentioned that when she got the vaccine she did not tell them that she was on steroids and an antibiotic. She commented that she was not in good shape when she took the vaccine to begin with. She is immunosuppressed and thinks that she should not have received the vaccination. But she also stated that she took the vaccine because she is a severe asthmatic and does not have a strong immune system so if she got COVID, she would die. Concomitant medication included benazepril (BENAZEPRIL) for blood pressure abnormal from an unspecified start date and ongoing; amlodipine (AMLODIPINE) for arrhythmia from 2014 and ongoing; rifaximin (XIFAXAN) for hepatic encephalopathy from 2014 and ongoing; lactulose (LACTULOSE)for hepatic failure, ammonia abnormal from 2014 and ongoing; levothyroxine sodium (SYNTHROID) for autoimmune thyroiditis from 1984 and ongoing; omeprazole (PRILOSEC [OMEPRAZOLE]) for reflux gastritis, chronic gastritis from an unspecified start date and ongoing; alprazolam (XANAX) for anxiety, post-traumatic stress disorder from 2009 and ongoing; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) for asthma from an unspecified start date and ongoing; ranitidine (RANITIDINE) for an unspecified indication, start and stop date were not reported.The patient previously took flu vaccine vii, olysio for hepatitis c and experienced histamine level increased, lyrica and experienced weight increased. Ten minutes after the vaccine was administered the patient experienced generalized aching on 01Mar2021 at 13:55 with outcome of not recovered. After twenty minutes she developed a pretty severe headache on 01Mar2021 14:05 with outcome of recovering. After 30 minutes she stared to feel nausea on 01Mar2021 at 14:15 with outcome of recovered. She stated that when she stood up to leave felt like started to feel dizzy on 01Mar2021 with outcome of unknown, and felt like she was going to faint on 01Mar2021 with outcome of unknown, her vision blurred on 01Mar2021 with outcome of not recovered and she had trouble getting into the elevator. She also experienced a loss of appetite on 01Mar2021 with outcome of recovering. The patient continued to describe her experiences noting that "things changed daily" and mentioning that she experienced fibromyalgia flare up on 01Mar2021 with outcome of not recovered, no energy been very tired on 01Mar2021 with outcome of not recovered , no energy been very tired on 01Mar2021 with outcome of not recovered , couldn't get warm- very cold, her skin was very cold on 02Mar2021 01:30 with outcome of not recovered, flu-like symptoms on 01Mar2021 with outcome of recovering, hands feel warm to touch, but she still feels cold on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, sick in Mar2021 with outcome of unknown, her bones hurt in Mar2021 with outcome of unknown, her muscles hurt in Mar2021 with outcome of unknown, wheezing on an unspecified date in Mar2021 with outcome of unknown. Lab tests and procedures included cardiac output: over 50 percent, echocardiogram: her heart was good and clear, electroencephalogram with unknown results, magnetic resonance imaging with unknown results, all on unknown dates. Therapeutic measures were taken as a result of pretty severe headache; Sender's Comments: Based on the available information, the company considers that a causal relationship between generalized aching, severe headache, feel dizzy, going to faint, vision blurred, no energy been very tired, very cold, her skin was very cold, wheezing and bnt162b2 vaccine cannot be excluded due to plausible temporal association. The Company considers the reported event fibromyalgia flare up is unrelated to bnt162b2 vaccine but more likely due to underlying medical history of ongoing fibromyalgia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-03-25 headache Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyan... Read more
Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyanosis. EMS gave breathing tx, 02 sats WNL. Declined transfer to hospital at that time for fear of Covid. Client exhibited confusion, oriented x 0, short term memory loss. Bronchial spasms resumed, EMS again called, transported via EMS to hospital. Diagnosed with transient global amnesia and hypercapnia. Client was transported to medical center for CT and MRI for r/o stroke. Stroke was ruled out. Client with c/o memory loss, confusion, and h'a are becoming less severe. Client states that senrory processing is slowed.
67 2021-03-28 throat irritation, headache something in her throat; rash/bumpy rash; nausea; vomiting; started having a taste in her mouth; tic... Read more
something in her throat; rash/bumpy rash; nausea; vomiting; started having a taste in her mouth; tickle in her throat, and she kept trying to clear her throat, and then her voice was gone; it felt like her throat was closing up.; rash/red rash; lost of voice; dizziness; headache; This is a spontaneous report from a contactable consumer. A 67 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiration date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 67 -years-old), single dose for COVID-19 immunisation. Medical history included diagnosed in 1978 with Gestational Diabetes, and that went away, but it came in 1995 and has been active and progressing ever since; Diabetes, Type Two; allergies to various medications; food allergy. Caller had concomitant medicines of unspecified anxiety medicine, pain medicine,anti-inflammatory, diabetic, blood pressure medicines, the statins. After getting the first dose of the Pfizer BioNTech COVID-19 vaccine, caller had adverse events that made her become hospitalized. She said she had developed dizziness, light headedness, headache, something in her throat, lost of voice, rash nausea, and vomiting. She was in the hospital for 5.5 hours. She originally has the appointment for the second dose of the vaccine on 25Mar2021 but it got cancelled. Caller got the vaccine on 04Mar2021, and the guy gave her the shot, and then said the would check on her in 10 minutes, because of the caller's history of allergies to various medications and foods. Caller reports that she started having a taste in her mouth, and then she got lightheaded, she was dizzy, she got a headache, she felt sick to her stomach and that progressively got worse to where she ended up throwing up twice at the hospital. Caller was given a Bendaryl, and some anti-nausea pills under her tongue, but she did not know she was rashy, until she got home, there was a rash on her chest, arms, back, and legs that was all bumpy and red. Caller started to feel a tickle in her throat, and she kept trying to clear her throat, and then her voice was gone. An ambulance was called, but her husband took her to the hospital because it was right across the street, because her doctor had advised her to get the shot at a site near the hospital because of her history of allergies. Caller reports that she was in the ER for like five and a half hours, and when she started to feel better, she said she wanted to go home and lay in her own bed if she is just going to be puking her guts out. Caller states that she went home and crashed and burned for a few days, with no voice, and she was still coughing to try and clear her throat, it felt like her throat was closing up. Caller confirms she was not admitted to the hospital for this reaction. All events started 04Mar2021. Treatment was given for all events. The outcome of the events was unknown. Caller had no other vaccines on the same day.
67 2021-03-29 chills, headache Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I t... Read more
Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I thought I am going to have a stroke; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; Chills; Headache; The chest pain was horrible; The joint and muscle pain were so severe; I am still little real nauseous; I feel like I mean like acid coming up constantly making me more nauseous; Unable to eat; The joint and muscle pain were so severe; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication includes supplements and multivitamins. The patient stated "I wanted to ask you and I have some horrible concerns I got my second COVID shot last Friday, and by Saturday night, I am not exaggerating, my symptoms were so severe I felt like I was going to die I mean literally die on 20Mar2021. I couldn't get to emergency room, I figured out I am just going to die, I just laid down and let my door open down so somebody could find me, the symptoms I was having was extreme nausea, chills, headache, the chest pain was horrible, horrible, the headache I mean I thought I am going to have a stroke, the joint and muscle pain were so severe. So I have been taking Tylenol, Advil (Treatment) finally this morning, yesterday was tiny, tiny bit better, this morning its little bit better but I am still little real nauseous and I feel like I mean like acid coming up constantly making me more nauseous and almost like unable to eat. Ever since Saturday all I will have been doing is three bites of chicken soup three times a day. What in the world is going on with this vaccine that it would cause those severe symptoms and my chest is still tight I still feel low congestion having hard time taking a deep breath in Mar2021". The outcome of the event "my symptoms were so severe I felt like I was going to die I mean literally die" was recovered on unspecified date. The outcome of the event unable to eat was unknown. The outcome of the rest of the events was recovering. Information on lot/ batch number has been requested.
67 2021-03-29 fever, fatigue Initially--fatigue, fever, muscle aches. On day 4--parethesia and numbness causing imbalance on le... Read more
Initially--fatigue, fever, muscle aches. On day 4--parethesia and numbness causing imbalance on left side. lasted a brief time--less than 20 minute. Day 5 paresthesia and numbness on waking up on left side, increased in intensity during the day. Difficulty walking and using left side. Muscle control lacking and balance very poor. The intensity of this fluctuates--there are days that improvement seems to be happening and then very bad days. Admitted to the hospital on Wednesday, March 24, 2021, via the ER. MRI, CAT scan, heart monitor, --these did not show evidence of a stroke as suspected at the time. The neurological symptoms persist, at times including numbing on the left side of my face.
67 2021-03-29 fever, lethargy Patient presented 8 days after her vaccine with fevers and lethargy. She subsequently developed DVT,... Read more
Patient presented 8 days after her vaccine with fevers and lethargy. She subsequently developed DVT, PE, and severe thrombocytopenia consistent with ITP. She has also developed encephalitis.
67 2021-03-30 malaise, sleepiness, headache, fatigue also had a headache; her eyes have been really sore, red and she has several broken blood vessels in... Read more
also had a headache; her eyes have been really sore, red and she has several broken blood vessels in her eyes; her platelet levels dropped; having muscle pain or some kind of pain, maybe joint pain that is in her hips; has had nausea and she has generally felt unwell; muscle pain; she slept for almost two days; felt unwell; diarrhea; abdominal pain; her eyes have been really sore, red and she has several broken blood vessels in her eyes; her eyes have been really sore, red and she has several broken blood vessels in her eyes; tiredness; eyes were yellow when she woke up that morning; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), first dose via an unspecified route of administration, administered in Arm Left on 09Mar2021 11:45, single dose as SINGLE DOSE for covid-19 immunisation. Medical history included lung transplant from May2011, immunodeficiency from May2011 and ongoing, strokes. The patient had dtap vaccine before Jan2021. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); prednisone acetate (PREDNISONE); tacrolimus monohydrate (TACROLIMUS). Patient reported that it has been about a week and a half of maybe more since her first COVID vaccine and she gets new symptoms almost everyday. Most of the symptoms aren't like put-you-down sick, horrible symptoms, they can be dealt with, but she has had a lot of them. She never got injection site pain and her arm never got sore. She had tiredness on the second day after her COVID vaccine, she slept for almost two days. She has a headache almost constantly. She is having muscle pain or some kind of pain, maybe joint pain that is in her hips. She doesn't have chills, a fever, injection site swelling or redness. She has had nausea and she has generally felt unwell all the time for a week and a half now. She is immunocompromised because she has had a lung transplant, that is the one thing that probably sets her apart is that she is immunosuppressed. She had the lung transplant almost 10 years ago now and she has been doing well. She is not on blood thinner medicine but she does take a baby aspirin everyday. Those are the only two things that she can think about. She doesn't know if all of that would make the symptoms from the COVID vaccine different for her. Most people she knows who have received the COVID vaccine have only had a couple days of tiredness and a sore arm. But she has a headache, been achy, and she just doesn't feel good. She also had a headache then and slept a lot, she was really tired. Later in the report caller clarified the first dose was actually 09Mar2021. She is not tired right now but she does still have a headache today, it is a pretty good headache. Her tiredness was Sunday and Monday of this week, confirmed to be 14Mar2021 and 15Mar2021. She says that she has recovered completely from the tiredness even though she feels like she could nap right now but she can't since she has a blood draw later. It is like she wakes up and every day she gets new symptoms. She had two symptoms that are not on the sheet of symptoms. The two she experienced are weird. On Saturday, a week and a day after her vaccine, her eyes were yellow when she woke up that morning. Confirmed date to be 13Mar2021. It was only that one day. She thinks that she has recovered completely. Also, her eyes have been really sore, red and she has several broken blood vessels in her eyes. Some of this is normal in the winter for her, but the yellow isn't normal for her. Normally, when she does get the blood vessels in her eyes they will heal in a day or so but the ones now have lasted much longer. They have been much slower to go away. It is not like there is a red spot, but it looks kind of red and kind of weird. The other symptom that is strange is that her platelet levels dropped. She was at 49 before her COVID vaccine and now her platelet level is down to 29. She does have normally very low levels for platelets but they are usually around 50. They have dropped substantially since her COVID vaccine. They dropped from 50 to 33 and then 5 days later her level went to 29. She is getting another platelet level drawn today, confirmed to be 16Mar2021. Her eyes being sore, red, and having broken blood vessels occurred probably a couple of days after she received the COVID vaccine. Specifically, her left eye felt like it had something in but she doesn't believe that it did. She used eye drops. Her eye just felt gritty. This is not like she had pink eye and she didn't wake up with this eye shut. It wasn't pink eye she knows what that is like. Her eyes had broken blood vessels and then they turned yellow then they turned red and have remained red. They are not sore today and she doesn't feel like she has gravel in her eye but the whites of her eyes don't really look clear. She says so far it has improved some but she will see since she wakes up every day and something new has happened, or something different or something has come back again. The good news is that she doesn't have all of these symptoms at the same time. She can't the remember the day pain in hips began but it is ongoing. She noticed this morning that the pain in her hip was not as bad when she had gotten out of bed. That pain has lessened there but the pain went to her head. Nausea and generally not feeling well: Probed for when this began and caller says that it has occurred for several days after she eats dinner, her stomach will be growling loud and that comes along with abdominal pain which doesn't really fit in with muscle or joint pain, she has no muscle there unfortunately she jokingly says. Sometimes this is all accompanied with diarrhea. It is not ongoing as of now, no date provided. She noticed that it comes and goes and sometimes she can eat and she is fine and sometimes she gets really sick feeling. It seems like if she doesn't eat then she doesn't get the symptoms but she knows that she needs to eat. Investigations: Her doctor has been having her do platelet blood tests about every 5 days since she took the COVID vaccine. She does not remember the dates of these tests off of the top of her head. She had a blood draw at the clinic the day before her COVID vaccine and her platelet count was 49 on 08Mar2021. For the result of 29 that was either last Thursday or last Friday, 11Mar2021 or 12Mar2021. Te outcome of the event scleral discoloration was recovered on 13Mar2021, tiredness was recovered on 15Mar2021, headache was not recovered, pain in hip was recovering, other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299104 similar report from same reporter
67 2021-03-30 influenza like illness, dehydration, headache, fever passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she ... Read more
passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she was dehydrated in hospital and did not eat a thing; stayed dizzy; confused; She had felt disoriented; foggy; it was like the flu shot; sleeping a lot; her vision would get very narrow; thumb pink; erratic body temperature; horrible headache; bodyaches; dry heaves; slight fever/ body temperature 104.4; injection site sore; lymph nodes swollen; This is a spontaneous report from a contactable consumer (patient). The 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 04Feb2021 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer - stage 2 from Jan2008; 29Jan2008 surgery, breast cancer. First surgery for breast cancer removal and lymph node removal, then the cancer went around the first and second lymph nodes so they had to go back in because they had to take out a bunch more and she had to give them permission to take out more lymph nodes. Concomitant medication(s) included ongoing simvastatin for High cholesterol; ongoing bifidobacterium bifidum, bifidobacterium longum, lactobacillus gasseri (PHILLIPS COLON HEALTH) she has high pain tolerance, had stomach cramp did not know what it was and one a day vitamin. The patient previously took bnt162b2 (BNT162B2), dose 1 intramuscular administered in Arm Right on 14Jan2021 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunization and experienced Injection site sore. The patient experienced passing out on 28Feb2021, injection site sore, lymph nodes swollen on 04Feb2021, thumb pink on 26Feb2021, erratic body temperature, horrible headache, bodyaches, dry heaves on 05Feb2021, she was 155 lbs before when she was in the hospital - and now 160 lbs on an unspecified date. The patient was hospitalized for passing out from 01Mar2021 to 02Mar2021. The event passing out leaf to emergency room visit. The patient lab tests and procedures which included cat scan/ cat scan groin area with contrast: normal; EKG: normal; blood workup: normal; Blood culture:normal, all on 01Mar2021; cat scan head and neck with contrast: normal and cat scan head and neck without contrast:normal on 02Mar2021. The outcome of the event thumb pink was recovering, erratic body temperature was not recovered, horrible headache, bodyaches, dry heaves recovered on 26Feb2021, and was unknown for the rest events. Reported as: Caller states that on 04Feb2021 she received her 2nd vaccine at around 3:30 pm, and then around 10 pm she had injection site soreness. The morning after the second injection around 4 am, she had site on her arm soreness, erratic body temperature with slight fever, horrible headache, bodyaches, and dry heaves. Her lymph nodes also swelled up again. Caller clarifies that this also happened after her first injection of the Pfizer Covid19 vaccine and on a similar timeline. Caller clarifies that 2 weeks later on 26Feb2021 she had ended up with horrible headache, dry heaves, headache, body temperature 104.4. She states that this lasted Friday night and Saturday night and Sunday she was feeling better. Clarifies that was the week of 26Feb2021. Caller states that her events were on a similar timeline and that her first vaccine was 14Jan2021 at 3:30 pm on Thursday. States that by 10 o'clock that night, injection site was sore. At 4 am, injection site was very sore. A couple of days later, her lymph nodes were swollen in her left leg, groin area, right arm under armpit. Adds that area under armpit was the size of her thumb. Also, on the left underneath her chest wall. She states that she has had breast cancer in that left breast. She states that the swelling went away completely, but that the groin area swelling took 2 weeks to go away. Unable to verbalize exact dates. Confirms that this was after the first vaccine and also occurred after the second vaccine. Caller then adds that she was feeling better Sunday, 28Feb2021 but that her husband then found her on the floor Sunday night at 8:45 pm. She states that she passed out. Monday she passed out again and was taken to the hospital where she stayed until 02MAR2021. Healthcare Provider also provides information that her son ran her to emergency room, and she is not familiar with the doctors there. Also, a doctor that she does not remember the third physician but it was a neurologist. Caller states that she was 155 lbs before when she was in the hospital - and now 160 lbs. States that she was dehydrated in hospital and did not eat a thing. Normally she runs around 160 lbs. States she had breast cancer so left arm cannot be used, so they used her right arm for both vaccines. caller adds that she had a cruise she was going to go on but refused to go on in 2020. States that she heard you will need to have a vaccination passport to travel in the future so she wanted to get vaccine. States she did not want to get covid. States that so many people have died. Caller clarifies that she was admitted to (Hospital Name) on 01Mar2021. Caller adds that she went to the hospital 2 weeks after the second dose. She states that is what makes them wonder if it is from the Covid vaccine. Adds that she is not saying that is what caused all of this, but that it is just a coincidence that it was exactly 2 weeks after the vaccine, exactly 2 weeks out when this happened. She states that she has been thinking if she should be wasting Pfizers time reporting this but it could be a coincidence or maybe a reaction. Caller adds maybe it is because she had 34 radiations, 8 chemo treatments, 1 year of Herceptine, and breast cancer. States that maybe she can save somebody else, or if a possibility, people can be prepared two weeks early. She adds that she is lucky she did not break an arm, leg. or bone. States that she doesn't know if maybe she can save some other person by sharing this information. Injection site sore: States that this was after both first and second vaccine. It stayed sore for about a week, and was just tender after that. If she touched it, she noticed, but it didn't hurt her from doing anything. With the first vaccine, injection site soreness started 14Jan2021 around 10 pm and completely resolved after about a week. She adds that with the second vaccine she also noticed injection site soreness that same day on 04Feb2021 around 10 pm also. She adds that it lasted about six days or seven days or so. It was the same way, tender the first day and then at 4 am was when it got really bad. That Friday 05Feb2021 was when it hurt worse. Adds that she went into hospital on 01Mar2021 on Monday. States she was feeling okay, stayed dizzy and confused and thought she was getting Alzheimer's or dementia but it cleared. At 11 pm on Sunday felt completely different, like the old her. States she was fine yesterday 15Mar2021. She had felt disoriented but is now feeling better and back to normal. Eratic Body Temperature: States that she started watching and recording her body temperature on 09Mar2021. She states that it was 104.5 on Friday, and Saturday and Sunday night she used a wet washcloth to her forehead. States that her body temperature initially was variable starting on 26Feb2021. She adds that it continued until Sunday 28Feb2021. On 26Feb2021, her body temperature was 104.5. She states that it was then low on Sunday 28Feb2021 and was 98 or 99. Adds that it had been erratic but that once the fever broke it has been between her normal which is 98.6 to 98.7. Adds that her and her husband know for sure that when she passed out the three times, her temperature was 94.4. States that her husband gave her aspirin for the temperature. Adds that her temperature has been between 97.9 to 94.9 and dropped to its lowest on Saturday 13Mar2021 at 10:35 am. She states that it is still doing this erratic behavior and that this morning it was 96 at 1 am and then 96.8 at 8 am. While on phone today, it is 97.1. Lymph nodes swollen: States noticed swelling at 4 AM 16Jan2021. States this occurred 4 am after both first and second injection. Occurred to groin area, right arm, and left arm. It was there for a couple of days and then it would just remind her it was there. The arm lymph node swelling went away after a few days, maybe before a week or so. The one in the groin was there for about two weeks. On a scale of 1 to 10, it was a 1.5 and was not something that people need to take an Advil or something for. Clarifies it was in the armpit except in the left side because they took those lymph nodes out during surgery in 2008. Also, she noticed lymph node swelling in the chest area. Lymph Nodes at second vaccine she also noticed them starting at about 4 am after the vaccine and it started hurting again. Caller reiterates both shots were given at 3:30 pm and then at 10 pm injection site gets sore.Then 4 am injection site gets more sore. She's been telling everybody to get the vaccine in the morning. Her symptoms lasted two weeks and then she was fine. Caller adds that her husband never felt a thing from receiving the vaccine. She states that the injection site was tender on her husband but gone the next day. Investigations: stated they looked at her in the hospital and said she was fine. The girl came back up and did more cultures and nothing grew. They were confused and so was she and she has been debating whether to call and waste time reporting but thinks that Pfizer needs to know what happened to her. Simvastatin: Adds that asked doctor if this caused her symptoms and he said no. Phillips colon: doctor 6 to 9 months later did scan, the next day was in emergency surgery and it was her appendix. It enlarged and had grown into the other organs. Doctor said it was a mess and it was ready to rupture as a precaution they wanted to remove it. Bayer product Code above expiration date states 0C09C and expiration is Mar2023. Thumb pink: thumb nail to finger print past where you bend it was where she noticed it was pink. States it is now 98% better. Friday 26Feb2021 afternoon at 1 pm, right thumb turned pink. She took a pen and marked where it was vertical and horizontally pink to scarlet in color. She put herself on antibiotics. She was not sure if maybe she cutting chicken and cut it, or closed finger in drawer. It swelled up twice the size, turned purple. Went all around the finger and it was hot. She thought it was going to pop off. She kept wondering what she was going to do to her thumb. She did jam it and cut herself 2 months ago. Clarifies it was right hand thumb. Treatment: took antibiotics, which she states they kept her on in the hospital in IV form. She started the antibiotics on Friday 26Feb2021. Took it Friday afternoon, Friday night, and Saturday and Sunday. She thought it was doing better Sunday night before she passed out. Clarifies Cephalexin, 500 mg daily (Keppra) three times a day and by mouth. Adds that she keeps this medication on her because she travels the world and it is good to have on hand since it is broad-spectrum. Passing out: 28Feb2021 Sunday night noticed the volume on television was driving her crazy and it was irritating. Around a quarter to 9 she got up to brush her teeth and go to the bathroom. She went pee and then fell off toilet. She got really really dizzy, and her husband was standing over her yelling asking what happened. She saw the wall and she did not know what happened. States she was out cold and he was calling her name but she did not hear him. She heard him asking what happened but it was in the distance. He got her to bed and about 20 minutes later (husband reports 30 minutes later) she was so dizzy and passed out again. She adds that this may have happened Saturday also because she was sleeping a lot and it was like she was seeing words repeat themselves over and over again and her vision would get very narrow. Her husband was note sure if she passed out on Saturday also, but said both times Sunday she was out cold. Monday 01Mar2021 she called her husband's office and woke up to the nurse on the other line screaming. She dropped the phone and heard her name being screamed over and over on the phone and when she picked it up the nurse said that she must have passed out even though she thought she was sleeping. The nurse got ahold of her husband in his office. She believes she passed out again Monday morning and was then in the hospital Monday and Tuesday. Hospitalization: On 01Mar2021, her husband is a physician and suggested she go to the hospital. She was trying to get ahold of her son and daughter in law. She sent them a text and called and they did not answer. Her sons phone was charging and when he looked at it he was on his way to her. She states that when she came to all three times, she was extremely dizzy foggy and confused. Adds that the nurse at her husband's office alerted her husband and he told her to stay in bed and her son came to help her and then drove her to ER. States she was there Monday 01Mar2021, and discharged Tuesday night 02Mar2021 about 4:30 to 6 pm. Caller does not want to file a report for her husband regarding the injection site soreness. She states it was like the flu shot. She clarifies that it was not his arm, it was the injection side. She states that these people who are going on and on about their arm hurting, it is the injection site. She states it is the injection site and will not be the arm. States that it is like the flu shot. States she does not want to file a report regarding her husband because it was injection site soreness and went away. Provides no additional information. Adds that this is a new drug and new disease and we do not know what the future holds Caller adds that she keeps a diary and started a diary so that she has everything recorded in terms of medical history. States that it is important that everybody do so. Family Medical History Relevant to AE(s): callers dad passed out at age 85. He found out he was diabetic and had heart issues. Also had a stroke at age 87 and passed away. Adds that between ages 85 and 87 he passed out every few months, he would do one of his passing out things. Caller also had a brother who passed out sitting at table and went forward into table. She states at that time her brother didn't realize he had stage 4 lung cancer, and her brother passed away 1 and a half years later. Caller adds that he smoked from ages 15 to 64, and quit at age 63 because the doctor told him to. No follow-up attempts possible. No further information expected.
67 2021-03-30 fatigue pt states she started feeling very bad and everything hurt the day after getting the vax. She has a... Read more
pt states she started feeling very bad and everything hurt the day after getting the vax. She has a lot of hair loss. She had to stay in the bed for the next couple of days because she had fatigue and body aches. 5 weeks after taking the vax she has swollen lymph nodes in both arm pits and he developed sore knots under the skin on the outside of her thighs. Her BP has become uncontrollable. She was on 10mg of bp medicine and then it was upped to 20 mg. About 7 days ago a diuretic and her BP is still very high. on 3/20/2021 it was 180/89. she checked it again a couple of hours later and it was 165/92. She has had symptoms of GERD since 3/22/2021. Blood work she had on 3/18/21 shows way too much carbon monoxide in her CO2. Her anxiety has increased since she was vaccinated. She has an appt w/ her PCP on 4/9/21. She is very concerned that she is going to die from taking this vax.
67 2021-04-06 headache Rash in her mouth/break out on her lips and her ear; Rash in her mouth/break out on her lips and her... Read more
Rash in her mouth/break out on her lips and her ear; Rash in her mouth/break out on her lips and her ear; Shingles; Pain; Ramsay-Hunt syndrome; Loss of hearing; Itchy on the left side of the face; Blisters on face, temple, ear; Left side of her face is scorched bright red and painful; Left side of her face is scorched bright red and painful; Numbness; no feeling in her mouth on the left, cheek, temple; Numbness; no feeling in her mouth on the left, cheek, temple; Blisters in her mouth; Pain, teeth started hurting went to her temple; Pain, teeth started hurting went to her temple; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 20Feb2021 (09:30) as a single dose, with route of administration unspecified, for COVID -19 immunization at the pharmacy/drug store (not a military facility). Medical history included shoulder surgery in Aug2020; ongoing abnormal blood pressure; ongoing heart disorder; and was in a pacemaker and defibrillator. Concomitant medications included carvedilol for abnormal blood pressure from 2012 and ongoing; losartan for heart disorder from 2012 and ongoing; and furosemide from 2017 and ongoing. On 05Mar2021, the patient had Ramsay-Hunt syndrome and loss of hearing. On 21Feb2021, the patient had pain/teeth started hurting and went to her temple. On 22Feb2021, the patient had blisters in the mouth; left side of the face was scorched bright red and painful; and numbness/no feeling in the mouth on the left, cheek and temple. On 23Feb2021, the patient had blisters on face, temple and ear. On 25Feb2021, the patient was itchy on the left side of the face. On an unspecified date, the patient had rash in her mouth/broke out on her lips and ear; shingles; and pain. The events, 'pain/teeth started hurting and went to her temple', 'blisters in the mouth', 'blisters on face, temple and ear' and 'pain', had resulted into physician's office visit. The patient's ENT had the patient put on treatment with valaciclovir (VALTREX) and prednisolone for the 'blisters in the mouth', 'blisters on face, temple and ear'; treatment for 'pain/teeth started hurting and went to her temple', 'left side of the face was scorched bright red and painful', 'itchy on the left side of the face', 'rash in her mouth/broke out on her lips and ear', 'shingles' and 'pain'; and unspecified ear drops for 'loss of hearing'. The outcome of the events was not recovered for 'Ramsay-Hunt syndrome', 'loss of hearing', 'pain/teeth started hurting and went to her temple', 'left side of the face was scorched bright red and painful', 'numbness/no feeling in the mouth on the left, cheek and temple' and 'itchy on the left side of the face'; was recovered on 04Mar2021 for 'blisters in the mouth' and 'blisters on face, temple and ear'; and was unknown for 'rash in her mouth/broke out on her lips and ear' and 'pain'. The patient had received the second dose of vaccination on 20Mar2021. Information about batch/lot number has been requested.
67 2021-04-12 throat pain Glands in her throat swelled up; her throat was inflamed; Painful to swallow; Throat pain, sore; her... Read more
Glands in her throat swelled up; her throat was inflamed; Painful to swallow; Throat pain, sore; her neuropathy, since the vaccine, has acted up.; her neuropathy, since the vaccine, has acted up.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in upper left arm on 15Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (did not want to get Covid). Medical history included hypertension (she has been on medications for it, and she doesn't know how long), Cancer (Cancer Survivor. for probably 8 years), ongoing Neuropathy (since she had chemotherapy 7.5 years ago), chemotherapy. Concomitant medication included telmisartan tablet at 80 mg once a day taken for hypertension (stated she has been taking it for a couple of years). The patient experienced her neuropathy, since the vaccine, has acted up on an unspecified date in 2021, glands in her throat swelled up on 20Mar2021, her throat was inflamed on an unspecified date 2021, painful to swallow on an unspecified date in 2021, throat pain, sore on an unspecified date in 2021. Caller stated she was the recipient of the Pfizer vaccine. Caller stated her first shot was 15Mar2021, and in 5 days, all of a sudden her glands in her throat swelled up, and asks, is that normal, Reclarified, caller stated the Pfizer vaccine, she was not sure but as she gets older, she shrinks. Caller stated that she was due to get her second shot next week and was a little leery. Glands in throat swelled up: Start: caller stated she did not know than stated 20Mar2021, she thought. Stated it was resolved, she did not feel it, it resolved 2-3 days later, maybe on the 23Mar2021. Caller stated it was weird, her throat was inflamed and it was painful to swallow. She did not know, it was hard to tell, it feels a little sore. Caller stated she did not know she has no idea. Throat inflamed caller did not the same day, maybe that Saturday, or the night before, she did not remember. She reports she did a lot of gargling with salt water and her throat was sore, what the heck. She stated she feels much better. Recovered. Caller stated she did not remember. In 2021, painful to swallow caller Stated probably the same day as the glands or the night before. She Stated no, it was not difficult to swallow anymore. She did not know the end date, it was better 3 days later. Throat pain and sore in 2021, caller stated no, it was all together around the same time. Caller stated she woke up with it. Caller stated the pain has gone, and she did not know the date, once it went away, she didn't think about it. She was not sure, if it was recovered, or recovered completely. Caller stated she has neuropathy because of chemotherapy, but reports that her neuropathy, since the vaccine, has acted up. Stated the vaccine must have been given between 1 and 1:30, she had the appointment at 12:45, but didn't get in after 1:00. Caller stated all she saw was N534, she thinks, it was an E or Z the way that they wrote it. Caller gave ZPN534, reclarifies, she stated she thinks they wrote it so sloppily.. She did not know if that was an E or ZPN534. I was having hard time reading it. It could be a E or it could be a Z, P, I think it was N 534. For events, her neuropathy, since the vaccine, outcome was not recovered, glands in her throat swelled up, outcome was recovered on an unspecified date in 2021, her throat was inflamed outcome was recovered on an unspecified date in 2021, painful to swallow, outcome was recovered with sequelae, throat pain, sore outcome was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.
67 2021-04-12 fatigue, fever My MOTHER had a health condition, diabetes and heart problems, she was at home with palliative care,... Read more
My MOTHER had a health condition, diabetes and heart problems, she was at home with palliative care, due to her condition, she was fine in the last month she was able to walk, shower, eat alone, she felt happy to be able to recover, she got the vaccine because the doctor advised her, the same day she got fever, and began to feel fatigued, 3 days later my mother died, she had heart attack from shortness of breath.
67 2021-04-13 malaise Patient presented to ED with difficulty walking, falls, right sided chest pain, lower extremity edem... Read more
Patient presented to ED with difficulty walking, falls, right sided chest pain, lower extremity edema, generally felling unwell
67 2021-04-17 chills, influenza like illness, sweating, headache Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell... Read more
Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; busted her lip and it was bleeding real bad; Weakness/ feeling weak; Feel weak in her arms and legs; Sweating profusely; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Foggy Brain; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) intramuscularly, administered in the left arm on 11Mar2021 (batch/lot number: EN6205) at 67 years old as a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Pharmacy/ drugstore. The patient's medical history included compromised immune status; respiratory illness, genetic /chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; asthma diagnosed since childhood; diagnosed allergies, allergies (seasonal and food); food allergies included gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, broccoli, cauliflower, cabbage, brussel sprouts, asparagus, all "percifirous"/ cruciferous vegetables; she also has allergies to cats, pollen, trees, grass, ragweed, mold, mildew, and dust; and allergies to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, and Clindamycin (patient does not have a manufacturer, lot or expiration to any of these medications). The patient had no family medical history. Concomitant medications included unspecified prescription medications for years which she did not feel they were relevant. On 11Mar2021, the patient experienced "weakness/ feeling weak" (weakness), "feel weak in her arms and legs" (weakness of limbs), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (faint), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (fall), "busted her lip and it was bleeding real bad" (bleeding lips), sweating profusely (excess sweating), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Flu-like symptoms), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Joint pain), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (muscle pain), and foggy brain (foggy feeling in head). On 12Mar2021, the patient experienced headaches, chills, itching rash on arms, back, neck and chest (itchy rash). On13Mar2021, the patient experienced blurred vision. It was reported that after the first shot, on 11Mar2021, patient experienced weakness, then she got home and she fainted, fell, and busted her lip and it was bleeding real bad. Then she began sweating profusely. She started feeling weak 30 minutes after getting the shot. Someone took her there because she would not have been able to drive. They brought her home and she was in the kitchen. While over the sink, she started to feel weak in her arms and legs. Before she could tell her husband that she was feeling weak, she dropped to the floor and everything was turning black. She fell face first and busted her lip and it was bleeding real bad. The weakness gradually started getting a little better on 30Mar2021. She is having to walk with a cane now because of the weakness. She was not using a cane before. Two days later on 13Mar2021, she was in the kitchen again and she felt that feeling coming and her husband was able to grab her and sit her down and she did not faint but she could tell it was coming. Patient also reported that from 12Mar2021, she is getting headaches every day off and on and in different spots of the head. Sometimes it is in the forehead, top, side and back. For about a good week, she had chills and it tapered off after the first dose. Also, on 12Mar2021, she experienced itching rash on arms, back, neck and chest. They were fine bumps and they just itch. The patient was recovering from the events faint, fall, bleeding lips, excess sweating, and itchy rash; and has not recovered from the events weakness, weakness of limbs, flu-like symptoms, joint pain, muscle pain, foggy feeling in head, headache, chills, and blurred vision. Follow-up attempts are completed. No further information is expected.
67 2021-04-17 headache Chronic obstructive pulmonary disease exacerbation; hypertension; vaccination complication; really s... Read more
Chronic obstructive pulmonary disease exacerbation; hypertension; vaccination complication; really sick; nausea; headache; The patient had decreased breaths from 12 to 10 breaths; This is a solicited report received from pharmacy. A contactable other healthcare professional and a consumer (patient) reported that a 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunization; treprostinil sodium (TYVASO, concentration of 0.6 mg/ml), resp inhalation (reported as via inhalation (IH) route) from 23Sep2020 (batch/lot number: 2101929; expiration date: 31Jan2022) to an unspecified date, delivered by Tyvaso inhalation device (TD-300/A) at 18-54 ug, QID (3-9 breaths), then via an unspecified route of administration from an unspecified date (batch/lot number was not reported) to an unspecified date, at 72 ug to 60 ug (12 to 10 breaths) for secondary pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension and ongoing chronic obstructive pulmonary disease. Concomitant medication included tadalafil taken for an unspecified indication, start and stop date were not reported. On 25Mar2021, the patient experienced events of chronic obstructive pulmonary disease exacerbation (chronic obstructive pulmonary disease, hospitalized), hypertension (hypertension, hospitalized) and reaction to COVID vaccine (vaccination complication, hospitalized). On an unreported date, the patient experienced events of really sick (illness), nausea (nausea) and headache (headache). On an unreported date, the patient had decreased breaths from 12 to 10 breaths (off label use). It was also reported that the patient had decreased breaths from 72 ug to 60 ug (12 to 10 breaths). The patient was really sick, nausea and headache. On 25Mar2021, 6 months and 3 days after initiating IH Tyvaso, the patient was hospitalized for reaction to coronavirus disease (COVID) vaccine, chronic obstructive pulmonary disease exacerbation, and hypertension. The patient was discharged from the hospital on 28Mar2021. The action taken in response to the events chronic obstructive pulmonary disease, hypertension and vaccination complication for treprostinil sodium was not reported, and dose was decreased due to the events illness, nausea and headache. At the time of reporting, the outcome of chronic obstructive pulmonary disease, hypertension, vaccination complication, illness, nausea and headache was unknown. The reporter did not provide causality for the events of chronic obstructive pulmonary disease, hypertension, and vaccination complication. The reporter's causality for the events illness, nausea and headache with IH treprostinil sodium was considered to be possibly related. Case Comment/Sender's Comment: The company has assessed the serious adverse event of chronic obstructive pulmonary disease, hypertension and vaccination complication as not related to IH treprostinil and TD-300/A device. Chronic obstructive pulmonary disease and hypertension were likely due to exacerbation of underlying COPD and Hypertension respectively. Vaccination complication was due to COVID vaccine. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is based on the company causality assessment. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event chronic obstructive pulmonary disease, hypertension, vaccination complication, illness, headache, nausea and the suspect drug BNT162B2 , TYVASO cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
67 2021-04-17 headache Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous rep... Read more
Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 04Mar2021 10:00 (Batch/Lot Number: EN6200; Expiration Date: Jun2021) as SINGLE DOSE for COVID-19 immunization at the doctor'ss office. Medical history included arthritis and was diabetic. Concomitant medications were not reported. It was reported that right after the first dose probably first, second, or third night in Mar2021 the patient had hallucinations. The patient also had headaches and sharp pain through arm/arm sore a couple of days after the first dose (probably started the next day or even the same day) which come and go. The patient recovered from the events in Mar2021 (a week or week in a half maybe two weeks before getting second dose). Follow-up attempts are completed. No further information is expected.
67 2021-04-17 headache bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; sec... Read more
bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; second dose received on 15Mar2021; first dose received on 09Mar2021; second dose received on 15Mar2021; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 15Mar2021 15:00, as single dose, for COVID-19 immunisation. Medical history included psoriasis, high blood pressure, scoliosis and low thyroid. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline; sertraline hydrochloride (ZOLOFT); and levothyroxine sodium (LEVOTHYROXINE), all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) received at age 67 years, via an unspecified route of administration in the right arm, on 09Mar2021 14:45, for COVID-19 immunisation. On 15Mar2021, the patient experienced bradycardia, was fainting, and had head and neck ache. One week after the second vaccine, in Mar2021, the patient was taken to the hospital due to the events. Treatment for the events included "had to have a pacemaker put in". The patient reported that she never had heart problems before, and she was curious if these could have ben side effects from the vaccine. The events resulted to physician office and emergency room visits, and hospitalization. The duration of the hospitalization was reported as 4 days. The events were reported as life-threatening illnesses. The patient was recovering from the events. Information about Batch/Lot number has been requested.
67 2021-04-19 fever Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiog... Read more
Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiogenic shock, progressed to multi organ dysfunction.
67 2021-04-20 fatigue, headache Severe headache on night of shot and every day since Tiredness daily causing sleep of up.to 20 ... Read more
Severe headache on night of shot and every day since Tiredness daily causing sleep of up.to 20 hours per day
67 2021-04-24 headache, chills, fever, sweating, fatigue Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; inject... Read more
Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; injection site redness; severe allergic reactions; slight dizziness; severe headache; nausea; weak; tired; feverish; sweat; had pain at the Pfizer Covid 19 Vaccine injection site; right arm started to swell; chills; extreme muscle pain; certainly extreme and joint pain; Heart beat seemed to speed up; Has not been able to walk or move body in normal fashion; This is a spontaneous report from a contactable consumer (patient herself) A 67-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) a week ago via an unspecified route of administration on 02Apr2021 at 13:45 hrs on the right upper arm as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.When caller was 18 they required a booster for Small pox and caller received the small pox booster on the leg in the same site where it was given at age 5. Caller's leg swelled up to 5 times the normal size, at the time caller was 18 years old.Took a long time for swelling to go away, a couple weeks. Caller requires it hindered sports activities during this time. On 02Apr2021, the patient started reported slight dizziness, severe headache, Shakiness, nausea, weakness, tiredness, have been feverish, pain at the injection site and stated that her right arm started to swell. The patient stated that through out the night of 02Apr2021, she had extreme muscle pain, certainly extreme and joint pain that was also extreme and heart beat seemed to speed up within the first hour and by the end of the hour. On 03Apr2021, the patient stated that her muscles and nerves seemed to be locking up like almost paralyzed. The patient described the events she experienced slight dizziness and didn't worry because it wasn't major and caller was driving herself and with in an hour the dizziness got worse. Caller had severe headache and had to drive home a significant distance and the time the caller got home, she reports being shaky, dizzy, had headache, nausea, was weak and tired and must have been feverish. Caller reports she must have been feverish because she was drenched in sweat by the time she got home and it was a 2 hour drive home from the vaccine administering facility. Caller had pain at the Pfizer Covid 19 Vaccine injection site, and caller's right arm started to swell.Caller clarified that the injection site was in the right upper arm, doesn't know what the muscle is called. Caller says she couldn't see if her arm was getting red, caller has some discs out in her neck and is unable to look at the arm. Caller could feel the injection site on her right arm was swollen and swelling. Caller reports fever was gone and fever got replaced with chills later on. Caller reports there was progression of the symptoms after the first hour. Caller states the information provided thus far was the first hour of her experience and through the night a lot of other things changed and added.Through the night caller had extreme muscle pain, certainly extreme and joint pain that was also extreme. Muscles and nerves seemed to be locking up like almost paralyzed: By the next morning, after caller had the Pfizer Covid 19 Vaccination, states she was not a doctor but all of her muscles and nerves seemed to be locking up like caller was almost paralyzed. Caller reports she couldn't move, couldn't get out of bed. It took a long time to get caller's fingers and toes moving and the rest of the body, but fingers and toes were the first ones. Caller was able to kind of release from muscle cramping. Whatever was going on, caller says can't tell exactly what was going on, does not have a Doctor in the home. States the information given should cover that part of the experience. Through the night had extreme muscle pain, certainly extreme and joint pain that was also extreme: Reports since the morning after receiving the Pfizer Covid 19 Vaccine, caller has had continued muscle pain, although not as extreme, its pretty extreme, and join pain. The patient has not been able to walk or move body in normal fashion. The patient stated that she had every side effect listed on the fact sheet at the top minus the swollen lymph nodes and injection site redness and she had two of the side effects listed under the severe allergic reactions. The patient wanted to know whether it is safe to receive the second dose of the vaccine. The patient lives in an isolated area where all through COVID-19 she tried to get information from the local medical clinics and they did not seem to stay informed. Caller states she has a doctor's appointment, and she will let them know the side effects she experienced after the first dose but she is not confident in the recommendations they might provide. Patient was given a list of side effects to look for, ones they were assuming, doesn't know if the hand out was published by Pfizer or not.The hand out listed emergency kind of side effects people were experiencing.Caller reports they are over age 65 range and knew a lot of people before her who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Caller was expecting the same reaction, caller was told by the Doctor she was in pretty good shape. Caller reports she had most all of the reactions except anaphylactic reaction of not breathing after receiving first dose Pfizer Covid 19 Vaccine. Caller is nervous about going for the second round of the Pfizer Covid Vaccine, is not sure how to proceed and would like that information. The case was assessed as serious medically significant for the event paralysis. It was reported that patient took Aspirin as treatment medication for pain. The outcome of the events was resolved for fever and nausea, resolving for swelling arm, unknown for swollen lymph nodes, Chills , Vaccination site pain, injection site redness, severe allergic reactions, sweat, shaky feelings, heartbeat increased, movement disorder and not resolved for all other events.
67 2021-04-24 chills, fever, sweating, headache cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in swe... Read more
cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in sweats; She is still cold/She is freezing cold; She is loosing her hair. clumps of hair falling out.; sinus headache; had issues with her thyroid; sinusitis like when she had COVID; palpitation; nausea; feeling achy like you have a flu/ aches and pain; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in arm left on 26Mar2021 15:00 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included atrial fibrillation on an unknown date. Caller added she takes medication for Atrial Fibrillation. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache since she was diagnosed with Covid. Caller had a funny sensation in her sinuses after the injection. It was a weird feeling, just like when she had Covid. She had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. She had a lot of allergies. The patient's concomitant medications were not reported. The patient experienced headache on 26Mar2021 with outcome of recovered with sequelae on 27Mar2021, achy, chills, fever, nausea on 27Mar2021 with outcome of recovered with sequelae on 29Mar2021, palpitation, sinusitis like when she had covid, cramps, stiff neck, couldn't move her neck, it was very painful, she was breaking out in sweats, still cold/ freezing cold, loosing her hair/ clumps of hair falling out, sinus headache and had issues with her thyroid on an unspecified date with outcome of unknown. The clinical course reported as follows: Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 26Mar2021 and scheduled to get the 2nd dose on 16Apr2021. Patient experienced headache, sinusitis like when she had COVID, nausea, feeling achy like you have a flu, fever chills, cramps ,aches and pain, palpitation. Patient had tested positive for COVID last 28Dec2020 that lasted for 6 weeks. Asking if 2nd dose will be more intense when it comes to reactions and if she can safely have the 2nd dose. She will see her cardiologist due to chest palpitations. She worked and had her first Pfizer Covid-19 vaccine 26Mar2021. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache on Friday immediately after her injection. Then was okay. On Saturday morning after waking up, she felt achy, nauseous, had a fever, chills, and a headache. On Sunday she was not feeling great. Even into Monday, she had fever and chills and felt the same as when she had Covid. Caller added she is not supposed to get sick. Caller states weighs 160 pounds, which she shouldn't be. After the shot she felt a sinus headache. Funny sensation in her sinus's just like it was when she had COVID. Once she had the shot, the original headache went away along with her stiff neck. She couldn't move her neck, it was very painful, it still happens. And she had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. Caller had lasting effects from Covid, but didn't know if these symptoms were related to the shot. She was breaking out in sweats. She was still cold. There was something going on. She was having her Vitamin D level and thyroid checked. She was loosing her hair, clumps of hair falling out. She had issues with her thyroid. Caller wondering if the vaccine was the cause. She was freezing cold. She hadheart palpitations and was seeing her Cardiologist next Thursday. Caller received the vaccine because she had Covid and didn't want to get it again. She was pretty sick. She worked around people and didn't want to be in a situation because not everyone wants to get the vaccination. Treatment of events included: She had not been to the doctor for this, she just jumped into bed and took Tylenol. The events didn't require a visit to emergency room or physician office. No follow-up attempts are needed. No further information is expected.
67 2021-04-24 fatigue face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinu... Read more
face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinus infection; Shortness Of Breath; pounding in my chest/throbbing in her chest; ringing in ears; flared up some digestive issues / digestive disturbances; flared up some digestive issues / digestive disturbances; red on left side/face redness; exhausted all the time; This is spontaneous report received from contactable female consumer (patient) reported herself. A 67 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199) on 10Mar2021 17:30 at age of 67 years old at single dose in right upper arm for COVID-19 immunisation. Medical history included: last year February, she was really sick with bad sinus infection not knowing about COVID at the time. Sometime later she got these horrible digestive attacks, ended up in her stomach and esophagus, horrible attacks where she couldn't breath, she has had acid reflux in the past. digestive problems stayed with her a really long time, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. She tested in April last year, it was negative (not detectable). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No adverse events (AE) following prior vaccinations. Patient had first Pfizer covid vaccine on 10MAR2021, approximately 10 days to 14 days after the vaccine her face swelled up, numbness and red on left side, went to see my doctor, he treated her with steroid and antibiotic for sinus infection, at the same time she had some shortness of breath and pounding in my chest, and had and still have ringing in ears since then, it kind of flared up some digestive issues she had last year. If she back up to last year February, she had a bad sinus infection, went to see allergist, family doctor and ENT, all treated her for sinus' before covid testing was even a thing, they didn't think of covid testing at the time. It ended up in her stomach and esophagus, horrible attacks where she couldn't breath, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. In March2020 her husband came home with covid, after that, talking to his doctor, she brought him meals outside of the door, it occurred to her that queried if this could have been covid. She tested in April last year, it was negative (not detectable), they were still not sure if it could have been covid. She was supposed to get the second vaccine, she postponed it, the numbness and swelling of face is gone, next shot was tomorrow. Since this was a delayed reaction, typically one to three days would be a reaction to the vaccine. she didn't associate it with the vaccine, asked if it could have been from the vaccine. She wanted to make sure that she was safe to get the second one. Response: Spoke from EUA factsheet for Recipients and Caregivers: LAB-1451-4.0 Revised: 06 April 2021: Sections: who should not get the PFIZER-BIONTECH COVID-19 VACCINE and what the risks of the PFIZER-BIONTECH COVID-19 VACCINE were. Spoke from attached VR Consumer- Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BioNTech Covid 19 vaccine). Your doctor/healthcare provider is in the best position to assess and advise you as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. Patient calling about the COVID vaccine. She states that she had the first vaccine 10MAR2021, and 10 days afterwards her face swelled up. She had numbness in it and redness. She went to the doctor and the doctor thought that maybe it was a sinus infection. So she was treated for that. She states that she did have a few other symptoms. To make a long story short, she was suppose to have the last vaccine last Friday. She postponed it for a week (postponed getting the second shot for a week). She wants to know what Pfizer thinks about her getting her second vaccine and her side effects. She says that somewhere between the 10th and 14th day, after receiving the vaccine the symptoms started and that was why she did not think she had a reaction to the vaccine. She has not had anything like that before, it was sort of a delayed reaction. She states she is better now. She had a few symptoms after the face things started and the only thing that she still has now is ringing in her ears. She states it all started around the same time as her face issues, or might have started a little after that. She confirms everything but ringing in her ears have completely resolved. She states that she did have some digestive disturbances, shortness of breath, and throbbing in her chest after receiving the vaccine. She asks if she can go back a little bit to explain. She states that last FEB2020 she was really sick with bad sinus infection not knowing about COVID at the time. She went to her allergist, then her family doctor, and then an ENT. She states that it was nothing like she has ever had, it was really bad. Sometime later she got these horrible digestive attacks, she has had acid reflux in the past but it was nothing like this. In March her husband had COVID and tested positive for COVID. She decided to get tested and she tested negative. She wonders if she had COVID earlier but at that time they were not testing for COVID. Her digestive problems stayed with her a really long time, and she was still on the medications her gastrointestinal doctor put her on. They are hypersensitive esophageal medication. She states that she has been exhausted all the time. The rest of the story she has told already. She states that after the face thing happened she started getting those digestive issues again. Her friend suggested that she call Pfizer, so she is doing that. She confirms that the vaccine card does not have an expiration date, NDC, or dosing information. She states it says 0.3 ml, but she cant see a point, so she doesn't know if its just 03. She states she got the vaccine to lessen her chances of getting a severe disease, in case she ends up in the hospital. Also, to keep herself safe from other people. She states she wants the second one because husbands works with the public and she wants to be protected when he comes home. She states that she has those gastrointestinal disturbances and is on amitriptyline 10 mgs for that. She states she also takes something for her thyroid but she has no major health issues. She states that she had a endoscopy and a colonoscopy as well as blood work done but she doesn't have any of the results because they are in her Beaumont chart where she actually got the vaccine. All of this was pre-vaccine so she doesn't know how relevant it is. The patient did not require a visit to Emergency Room, but visit to Physician Office. The only thing similar had a sister who reacted to a shingles vaccine, She has no information about her sisters reaction to the vaccine. Outcome of event ringing in ears was not recovered, for others was recovered. No follow-up attempts are needed. No further information is expected.
67 2021-04-24 fever, fatigue, malaise kidney was not functioning properly; GFR was 41 (stage 3)/ low GFR; Stage 3B Kidney disease; 100.2°... Read more
kidney was not functioning properly; GFR was 41 (stage 3)/ low GFR; Stage 3B Kidney disease; 100.2°F fever; whole body was aching; tired; right kidney started aching and then the left kidney; leucocytes in her urine; high creatinine; bladder symptoms; oil bubbles in my pee/bubbles in her pee; I don't at all feel well; I have got lots of fluid in my body around my middle; put on about 5 or 6 pounds; cystitis; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot no. PEL9261, via an unspecified route of administration on 05Feb2021 as single dose for prevention of COVID 19 virus. No relevant medical history and no concomitant medications. The patient previously took the first dose BNT162B2 for COVID-19 immunisation (lot no. batch/lot number: EL1284). The patient received the first dose of the BNT162B2 on 15Jan2021. She had a reaction to the vaccine, had a mild reaction with first one she felt like if her heart warmed up and a burning sensation in her left side of the neck and face. She received the injection on her left side. She was kept for half an hour and then she had a mild headache and slept. She also had fever, pain at the injection site and felt very tired. She received the second dose of the vaccine 5 weeks ago. Several days after second dose on Saturday mornings, started having 100.2°F fever for two days and her whole body was aching. When the fever disappeared, she was very tired that week. Her right kidney started aching and then the left kidney, there were also bubbles in her pee and it went worse (no blood in the pee). A few weeks ago, she went to the urgent care, because a week before there were leucocytes in her urine and she took antibiotic. On Monday, she saw the urologist and the urologist sent her a CT scan and a blood test. The blood test results were abnormal so she didn't have a CT scan done because it could be dangerous. Her creatinine was high and her GFR was 41 (stage 3), she didn't know her kidney disease stage until they have the results (Monday). She was very healthy, didn't take drugs and there's no history of kidney disease in her family, also she exercised every day. She would like to know if something similar has been reported with the Pfizer-BioNtech Covid-19 vaccine because she's trying to understand these symptoms that came from nowhere. She knew the Covid-19 could cause kidney problems. She would like to know if there's any live virus in the Pfizer-BioNtech Covid-19 vaccine. She was normally completely fit and healthy. She did not have any abnormality whatsoever and no big medical history. She had the 2nd Pfizer job about 4-5 weeks ago and in the last 3 or 4 weeks at least, she has been having aching kidney, kind of oily bubbles in her urine and she went to see a doctor, a specialist to send her for some test. Today, she discovered that she got a high creatinine and low GFR so that meant have got at the moment, the picture was stage 3B Kidney disease. She had no family history of that. She never had any problems before. She just wondered whether there was any other case report like vaccine should be toxic to her kidneys. This was so out of the loose. Just so uncharacteristic. She stated that probably more than that, she thinks it started because she did not realize at first, it just made her feel tired, her kidney was aching because she was working too hard. It has developed over, it was hard to say. She had the second shot and she had fever for two days. She was so tired anyways. So, she was not exactly sure whether it began exactly when she had it but she certainly did not have it before or whether it came on a few days after or a week after, she was not sure but she knew that it has got worse and now, she was in a situation where she had a CT scan today (19Mar2021). So, she went to the doctor probably on Monday or Tuesday to find out exactly what was going on but she had absolutely no history of anything like this. She had no family history. She was completely healthy. She normally exercised, aerobic exercise most days. She was a healthcare professional (nutritionist). This had come as a complete shock to her today. She was phoning because she wanted to know if there were any other case reports. She knew it was very early and there was not much research on the vaccine but she did not know whether anybody else had reported having kidney problem. She knew you can get kidney problem with the actual disease, with the virus rather but she did not know if the vaccine could cause that. She knew it had something to do with the vaccine and obviously, it may be temporary and she can deal with it. She just needed tab a little bit insight of what to do next. She was not on her normal weight because she has put on about 5 or 6 pounds in the last few weeks. So, she thinks she had got so much fluid. She was normally 5 foot 5 (inches) and her weight was normally about 130 pounds. Actually, it was less than that so it was 127 or 128 pounds but at the moment she was 134. She had got lots of fluid in her body around her middle. When she had the second shot, she had the fever for two days on the Saturday and Sunday and got really tired on Monday and Tuesday and she went there and felt a little bit better but she cannot remember when her kidney started aching. She did not know if it was immediately or whether it was the next week. It started gradually and it had got worse in the last couple of weeks. So, the ache had got so much worse and the amount of bubbles in her pee and urinary symptoms had got worse in the last, at least probably 2 to 3 weeks or so. She had nothing at all before the second vaccination. She would say that it was shortly after she carried on feeling tired and then her kidney started aching and then she developed urinary symptoms. So, that was within a week to 2 weeks of having the shot. She definitely noticed that she had the symptoms and it may have been sooner. She was not entirely sure. It may have been the same week. She honestly cannot remember because it began gradually and she started to feel like she was getting cystitis and she did not think anything over it and then it got progressively, her kidney started hurting and she got really tired and then she just started having oily bubbles in my pee. When probed for the LOT# of vaccine, the first one looked like as EL1284, and the second one, it looked like PEL9261. It could be 4916. She had got the card but she did not know exactly. It was terrible writing. She was not sure it was hard to read. The first one was in her left shoulder and the second one was in her right shoulder. She felt it was related. It has taken incident from when she had the vaccine. Well, she was obviously not a 100 percent sure that was why she was phoning to ask if there is any other similar case report. When probed for the treatment, she stated no, not yet. She only found out today that what happened was she went to see a neurologist this week and on Monday and they organized her to have a CT scan today and some blood work and when she got to the CT scan center today and they looked at the blood work and they said that her levels were too abnormal to have the CT scan with the contrast dye. It would be dangerous. So, that was when she found out it was an abnormal result. So, it just happened today. So, she had not even seen the results of the scan yet and had not seen the doctor but she just knew that her blood was abnormal and her kidney was not functioning properly and trying to find out whether it was related to the vaccine because she needed to find out how to manage it going forward. She was hoping if it was due to the vaccine she can, it has been toxic stroke to her kidney and then she can workout how to deal with it hopefully reverse the situation but she had no Idea but she was just trying to get the feeling for what this could be. She did not have the results of the CT scan yet. She only got the results of the blood which said her kidney, when she went to have the scan her doctor asked her to have the scan and then to have a second scan to what they call a contrast dye and the technician said that when he looked at her blood results he said she cannot give her the contrast dye it was too dangerous. She needed to phone the doctor and so he phoned the doctor and the doctor said just do the scan without the contrast dye and they told her what the blood results were. So, she looked online and she can see that it was Stage 3B Kidney disease and she was in the stage of shock and she was feeling before she went to have this test that this was related to the vaccine because it has come since she has had the vaccine, so close to her having it so now she was more convinced and she just wanted to see anybody else has had this. Obviously, the doctor would not know about this because this was so new and so she needed to workout on how to deal with what has happened to her. Her creatinine was 2 and GFR was 41. With second one she had the fever for few days and she felt very tired, and then she developed some bladder symptoms, and she thought maybe she just had something like cystitis, and then she was very tired, her kidney started aching and particularly on the right hand side but on the left as well, it's got worse and worse to point that she got oil bubbles in her pee and she went to see neurologist on Monday, she had the blood test and today she got scan, a CT scan and she meant to have a consult after the scan with the scan but when they saw the blood result, which she has not seen, they said that was so abnormal they could not get her the contrast dye, so they said because of the result, she suddenly got out of nowhere and stage 3B kidney disease, and she had not gotten the result of the scan yet but she has sent in on stay, but she didn't at all feel well, haven't felt well since she had the vaccine she personally felt it had something to do with the vaccine because she did not have any family history of kidney disease or anything related to that and she never had an issue, never even had kidney infection so, she phoned up today to off Pfizer whether there have been any other case reports, because she had to go back and see her Urologist now and he won't know because it's obviously such early days with the vaccine and there not any proper Clinical Trials to, she would think to reflect this. She was concerned about the side effects and she just wanted to know because now, she knew had to deal with it, and she was, obviously that came as big shock to her that she just wanted to, if there have been any, she knew that the Covid virus can cause kidney disease, but I didn't know whether the vaccine has been showing to do that in any other individual. Results of tests and procedures for investigation of the patient on 15Mar2021: blood test, result: creatinine 2 and GFR 41. The outcome of fever and tired was recovering, while outcome of other events was unknown. Information on the lot/batch number has been requested.
67 2021-04-24 headache, fever, sleepiness, fatigue sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot,... Read more
sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; This is a spontaneous report from a contactable Nurse (patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 (Batch/Lot Number: ER8734) as SINGLE DOSE (at the age of 67 years) for covid-19 immunisation. The patient had the first dose of BNT162B2 for COVID-19 immunisation in the left arm lot number EP7534 and the patient experienced peripheral swelling in left leg and blood clot. Medical history included ongoing thalassaemia beta Caller stated she was diagnosed with this in her later 20s or early 30s. The patient's concomitant medications were not reported. The patient experienced fever (disability) on 06Apr2021 20:00 with outcome of recovered, real achy (disability) on 06Apr2021 with outcome of recovered, terrible headache (disability) on 06Apr2021 with outcome of recovered, weak (disability) on 07Apr2021 with outcome of recovering, really thirsty (medically significant) on 07Apr2021 with outcome of recovered, tired (disability) on 07Apr2021 with outcome of recovered, sleeping for 3 days on an unspecified date with outcome of unknown, left arm hot, red, and swollen at injection site on 06Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 102, body temperature: 101.9, body temperature: 106, body temperature: 101.6. Therapeutic measures were taken as a result of fever, real achy, terrible headache, weak. Treatment: Advil. The patient is not in a study or programme. No Additional vaccines administered within last 4 weeks. Events were considered related for real achy, terrible headache, weak, really thirsty, tired, and left arm hot, red, and swollen at injection site. Follow-up attempts completed: case closed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for fever and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-04-26 sleepiness, chills, malaise, headache hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pr... Read more
hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation . Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported. The patient experienced fall on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed on 17Mar2021 with outcome of recovering , dizziness on 16Mar2021 with outcome of not recovered , sleeping a lot on 17Mar2021 with outcome of not recovered , hot and cold on an unspecified date with outcome of unknown , very ill on an unspecified date with outcome of unknown , felt horrible on an unspecified date with outcome of unknown , clammy on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy on an unspecified date with outcome of unknown. The events fall and contusion were considered Important Medical Events. The remaining events were non serious. No follow-up attempts are possible. No further information is expected.
67 2021-04-27 fatigue She was 'bouncing off the walls'.; unsteadiness; Nausea; extreme dizziness; fatigue/bad enough that ... Read more
She was 'bouncing off the walls'.; unsteadiness; Nausea; extreme dizziness; fatigue/bad enough that for 3 days she couldn't work; This is spontaneous report received from Pfizer Sponsored Program Support from a contactable consumer (patient). This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in upper left arm on 15Mar2021 09:30 (Lot Number: EN6207) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient experienced nausea on 15Mar2021 18:00, extreme dizziness on 15Mar2021 18:00, fatigue/bad enough that for 3 days she couldn't work on 15Mar2021 18:00, she was 'bouncing off the walls' on an unspecified date, unsteadiness on an unspecified date. She went on 15Mar2021 to get her first shot and then she was went for her second vaccine this past Saturday. Patient stated they denied giving her the 2nd dose of the covid vaccine after hearing about her side effects form the 1st one. She would like to know whether she needs to get the 2nd dose. She had pretty bad reactions to the first shot. She got the shot around 09:30 in the morning and by 6 pm she felt the reactions. Patient reported the following side effects form the 1st dose of the covid vaccine: nausea, extreme dizziness and fatigue, bad enough that for 3 days she couldn't work. She was 'bouncing off the walls', unsteadiness and spent the next three days in bed due to fatigue. There was no event require a visit to emergency room and physician office. There was no prior vaccination (within 4 weeks) and no adverse event following prior vaccinations. The outcome of event nausea was recovered on 16Mar2021, extreme dizziness and fatigue/bad enough that for 3 days she couldn't work was recovered on 18Mar2021, She was 'bouncing off the walls' was recovered on an unspecified date, unsteadiness was unknown. No follow-up attempts are possible. No further information is expected.
67 2021-04-27 pneumonia multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past m... Read more
multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past medical history of hypertension and hypothyroidism. Status-post spinal decompression due to stenosis. The patient then developed worsening issues with a surgical site infection. Patient has had numerous bouts of C diff. Staff notes patient is to have GI consult in the near future. Patient is seen today in her room. Patient was once again diagnosed with C diff and is currently being treated with antibiotics. Patient notes no bowel movements today. Patient has not had any issues with intake recently. The patient's weight has declined partially due to likely diarrhea. Patient's blood pressure continues to be monitored closely as it has been on the lower side of normal. Patient's potassium 2.9 on CMP. Patient's other care and therapies were reviewed. 2/28/21 Patient was admitted the hospital after found to be anemic at skilled care facility where she is being treated for C diff infection recurrent Lea. Patient was transfused. Patient was also found to have pneumonia/lung mass. Patient has struggled with electrolyte dysfunction. Patient had to be transfused a second time. Patient did well with second transfusion. Patient was found to be hypokalemic. Patient did well with potassium replacement. The patient was advised will have to do outpatient PET scan. Patient was found to have positive blood cultures as well 4/26/21 68 y.o. female who presents from nursing home with complaints of elevated white blood cell count. According to nursing home records patient had CBC checked on Saturday 04/24/2021 and her WBC count was found to be 50,000. At that point in time no other orders were given and patient was not sent in for evaluation. CBC was repeated this morning and WBC count found to be in the 70,000s. Patient was sent in for evaluation this morning. In talking with the patient, she denies any runny nose, sinus drainage or cough. Patient does report shortness of breath. Patient denies any chest pain or palpitations. Patient denies any dysuria, hematuria, fevers, or chills. Patient denies any nausea or vomiting. Patient does report diffuse pain across the lower abdomen. She does report chronic diarrhea. Patient had C diff stool checked on 04/13/2021 and was negative. (4/26 cdiff positive) Of note patient does have known lung mass that was seen on chest x-ray and PET scan. Patient reports that she does not want anything done and understands it could be cancer. And continuing to question patient, she reports she wants to be a DNR and does not want any aggressive measures.
67 2021-04-28 nasal congestion Her lungs did the same thing where they had closed; Her lungs did the same thing where they had clos... Read more
Her lungs did the same thing where they had closed; Her lungs did the same thing where they had closed/her nose did the same thing where it closed as well/only it was a lot worse with her lungs and her nose; her nose did the same thing where it closed as well; She was breathing through her mouth because she couldn't breathe through her nose.; She had sat up for 4 nights trying to sleep.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8733) via an unspecified route of administration into left arm on 30Mar2021 (at the age of 67-year-old) in the morning as single dose for COVID-19 immunisation. The patient's medical history were not reported. There were no concomitant medications. Historical vaccines include: INFLUENZA VACCINE on an unspecified date for immunization where she got sick for a week and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 09Mar2021 08:30 AM (at the age of 67-year-old) for COVID-19 immunization and feeling like her lungs were starting to close up and her nose closed up completely, hard time breathing when doing anything that was exerting herself, she still had a hard time with her breathing and short of breath. It was reported that patient got her second dose on 30Mar2021 in the morning and on 31Mar2021 almost the same thing pretty much happened as the first one, only it was a lot worse with her lungs and her nose. Her lungs did the same thing where they had closed and her nose did the same thing where it closed as well. She already had everything ready to use for nebulizing and that opened her lungs but it didn't open her nose. It was further reported that since 31Mar2021 she had sat up for 4 nights trying to sleep and she was breathing through her mouth because she couldn't breathe through her nose. The patient went to her doctor's clinic where she was given treatment for the events reported; she was put on a heavier nebulizer; that kind of opened up her lungs and her nose and then her doctor also put her on prednisone. Outcome of events "she was breathing through her mouth because she couldn't breathe through her nose" and "she had sat up for 4 nights trying to sleep" was unknown while for all other events was recovering.
67 2021-04-28 fever, fatigue This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Lot Number: ER2613) (age at vaccination: 67-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no, and no known allergies. The patient was not pregnant. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). On 23Mar2021 13:00, the patient was tired and slept, 25Mar2021 through 31Mar2021, had Low grade fever and fatigue. On 31Mar2021, thumbs turned purple and looked bruised Went to emergency room. All fingers were turning purple and swelling, could not bend fingers. Hurt to touch anything, couldn't open containers. Spent 2 nights (31Mar2021-01Apr2021) at hospital. Infectious disease doctors both agreed it was a reaction to the Pfizer Covid shot. Also CT scan at hospital showed a small nodule in the right lung. There was no nodule in the CT scan from 09Feb2021. Saw pulmonary Dr 14Mar2021 she and her colleague also believe the nodule was from the vaccine and she need to have another CT scan early May to see if it is gone. Skin peeling off thumbs and first fingers. On 02Apr2021 fingers less purple and moving some. Saw Dr 05Apr2021 wanted pulmonary appointment as soon as possible. 03Apr2021 through 12Apr2021 afternoon the patient had fatigue. The events resulted in: Emergency room/department or urgent care. No treatment received for events. Covid test (Nasal Swab) on 31Mar2021 showed Negative result. The outcome of the events was not recovered.
67 2021-04-28 headache collapsed, head hit the tile floor of bathroom; collapsed, head hit the tile floor of bathroom; righ... Read more
collapsed, head hit the tile floor of bathroom; collapsed, head hit the tile floor of bathroom; right arm was bruised; corner of her eye was purple/bruised; feeling nauseated; Headaches off and on; pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6208) intramuscular, administered in Arm Left, at the age of 67-year-old, on 19Mar2021 11:00, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma and Allergies. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203) single dose, at the age of 67-year-old, on 26Feb2021, for covid-19 immunisation and experienced slight ache in her left arm, headaches, and mitral valve disease. On 20Mar2021, the patient had headaches off and on and the patient mostly woke up with them. The patient doesn't know if the headaches were from pollen in the air since it is Spring time or mold. On 24Mar2021 at 4am, the patient got out of bed because she had to use the restroom. As soon as the patient took the first step into the tile floor of the bathroom, the patient collapsed. The patient didn't fall, the patient collapsed on the file floor. Her head hit the floor. Her head was killing her when she was laying there. The patient used the restroom and went back to bed. The patient got out of bed because her head was killing her. The patient guesses she threw her right arm out to brace herself, because she noticed her right arm was bruised the morning of 24Mar2021 when she went to shower. The patient took Equate 500MG for the events head hit the tile floor of bathroom, headache, and right arm was bruised and used a wash cloth with cold water as a cold compress and applied it by her eyebrow, the corner of her eye was purple/bruised. It looked like she had eyeshadow on. On 24Mar2021, she was feeling nauseated. Thankfully, she had the next 2 days off (Thursday and Friday) because she didn't feel so hot. On 26Mar2021, the patient called her PCP and was asked if she wanted to come in/ make an appointment. Since, the caller was planning to meet with the surgeon about her upcoming surgery on 29Mar2021, it didn't really fit into her schedule. She was undergoing all these tests, etc. It was determined her surgery was going to happen after receiving the second vaccine. The surgery is hopefully a mitral valve repair. The patient mentioned that her provider is aware of her experience with the COVID vaccine. The patient saw the surgeon on 29Mar2021, and she told him all about her experience. He advised the patient to call her PCP and schedule an appointment with them. She saw her PCP on 01Apr2021. She told her PCP what happened and her PCP asked why she didn't go to urgent care. The patient doesn't really know why she didn't, she just thought she was going to feel better. The patient thought she would work through the pain since Mar2021. Plus, she had everything going on with her surgery- like finding out she had to have the surgery and going under other tests. Her PCP wanted her to go to radiology to have a MRI of the head/brain done. She had the MRI done at 3:00PM on 06Apr2021 and the results were negative. Up until last weekend, she still felt "headachy". The patient has headaches too because of stress knowing her surgery was scheduled in a matter of 2 weeks, so she didn't know if the headaches she was experiencing was because of the COVID vaccine, stress, allergies, etc. The patient was certain the headache she experienced the day after she collapsed, was due to the collapse. The patient clarified that she knew it was more of a "collapse" instead of a fall because all the furniture leading to the bathroom, like the loveseat, lamp, cedar chest, etc, were all intact with no marks. It was like all of a sudden she collapsed. Her bruising is all gone, but there might be a slight mark that is like yellow and green (because the bruising changes colors) on her arm. Her eye was okay. The patient will have her planned surgery on 15Apr2021. The events required physician office visit. The patient underwent unspecified lab test and procedures relevant to her upcoming surgery but no other testing in regards to her symptoms after the COVID vaccine. Outcome of headache was not recovered, the events corner of her eye was purple/bruised and right arm was bruised recovered in 2021, while it was unknown for the other events.
67 2021-04-28 nasal congestion she still had a hard time with her breathing when she was doing anything that was exerting herself t... Read more
she still had a hard time with her breathing when she was doing anything that was exerting herself to get things done/ short of breath; she started to feel like her lungs were starting to close up; her nose closed up completely; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 09Mar2021 at 08:30 (batch/lot number: EN6199) as a single dose for COVID-19 immunisation. The patient has no medical history and no concomitant medications. Historical vaccine included flu shot for immunization and got sick on an unspecified date. No prior vaccination (within 4 weeks prior). No family history related to adverse events. The patient experienced she started to feel like her lungs were starting to close up and her nose closed up completely on 09Mar2021. She said that she wanted to let Pfizer know about the symptoms she had gone through when she got the shot. She received her first shot 09Mar2021 and it was at 08:30 am and then around mid-afternoon that same day she started to feel like her lungs were starting to close up and her nose closed up completely. She has a nebulizer machine and she used that and it opened up her lungs but it didn't open her nose up at all. So she sat up for a couple of nights with her nose not working right and she had to breathe out of her mouth. Days later here nose finally opened up and it was breathing good but she still had a hard time with her breathing when she was doing anything that was exerting herself to get things done. She would become short of breath. It was kind of that way when she went in for her second one, she was better at that time but she wasn't the greatest. When she had went in for second shot and told them about what she experienced after the first shot, they didn't do anything and they said that was what should be happening which was scary. They gave her the second shot even though she was very reluctant on it and she did it anyways. With that, what she experienced was even worse than what she experienced with the first shot. She got her second shot on 30Mar2021 in the morning and then the same thing pretty much happened as the first one, only it was a lot worse with her lungs and her nose. Her lungs did the same thing where they had closed and her nose did the same thing where it closed as well. She already had everything ready to use for nebulizing and that opened her lungs but it didn't open her nose for at least 3 days or maybe it took longer for her nose to open. She had sat up for 4 nights trying to sleep. She was breathing through her mouth because she couldn't breathe through her nose. It was a horrible time trying to breathe. It was unreal. It was kind of scary when you're trying to breathe and you're not getting any air. She had went to her clinic and she was put on a heavier nebulizer and that that one kind of opened up her lungs and her nose and then her doctor also put her on prednisone. Besides that she was given another nebulizer that wasn't as harsh or intense for her to use for all of her reactions or if she needed it during the night. Finally she was getting back on the mend now to where at least she can breathe through her nose and her mouth. Her provider thought that she should report this because she just cant figure it out. She knows that when she gets flu shots she gets sick and the same thing happens like now. The first time she got a flu shot she was sick like that for a week and she thought that maybe it was just a fluke so she did it a second time and the same thing happened. With this shot, she didn't know if she would want to get it again or not but people say that you should so she thought to give it a chance and then it turned out the same way with the second shot. It was not good. She doesn't know if there was something in those that was not a good thing or her to have or what. She didn't end up in the hospital even though she was pretty close to going up there. Probed for names, , lot numbers and expiry dates for all previously mentioned medications such as the different nebulizers, prednisone, and the flu shots from previously and she says that they were fairly new, she doesn't have the box now because she used them and when she was done she tossed it. The products weren't old and they didn't have old expiry dates. Probed for information such as , lot number and expiry dates for previously administered flu shots and she declined to provide and said that was many years ago. Provided mailing address and then caller stated that she doesn't want to be bombarded with anything if it has nothing of importance but she doesn't want it really. She doesn't want a lot of stuff to read through if it was not of importance. Informed caller that all information was voluntary in what we ask and she does not have to provide her mailing address was if she was not comfortable doing so and she asked this agent to remove her mailing it's because she always hears stuff on the news. Caller confirmed that this was her first time speaking to someone about what she has experienced. Probed if her side effects began on the same day she received her vaccine, 09Mar2021 and 30Mar2021 and caller said that for the first dose of the COVID vaccine on 09Mar2021 the side effects started mid-afternoon and for the second dose on 30Mar2021 the side effects started a little later and it wasn't on the same day. She had started feeling it that day but she really felt them the next day. She could tell it was kind of starting to do it at a slower process but when it happened it was really worse then the first time. Caller confirmed dates of 09Mar2021 and 31Mar2021 for when her side effects began and she says she was still feeling a little bit like she did with the side effects. She still has where if she was doing a little more exertion stuff then it seems like she still was having to sometimes stop and get her breath but it was getting better now. She doesn't want to go through that again, that was horrible. Caller said it seemed like if you didn't get the COVID vaccine then you couldn't go out in public without a mask on for the rest of your life or even if you go to some places, like a concert or an event, if you didn't have the COVID vaccine then they were going to card you and if you didn't, you know what. She has a friend who went to get it because he was working and he was around people and she thought that was important too with her being around him and that was the other reason she got the COVID vaccine. She didn't really want to but she did it anyways. She probably should of just taken her chances and if she got COVID then she got it and it probably wouldn't be as bad as putting something into her system that doesn't even like her. It was hard. That was just how she was feeling. It was a bad thing, you know. Her mom couldn't (well, she has been gone since 2000) but anyways, her mom could never get flu shots either years ago. The caller doesn't know if there was something with that that she doesn't know. All she knew was that these shots don't like her. Probed for relevant test results, concomitant products and medical conditions and caller says no, she was not sick and she didn't take anything before. She wasn't sick, if she was sick she would have thought that maybe she felt like not from the sock but she didn't feel sick. She takes her temperature every day and she has been for the better part of this whole last year and she never had a fever. She couldn't take her temperature during all this because she couldn't breathe when her mouth was shut. She said that the only thing what she doesn't really understand was that if you can still get COVID after getting the shots, then why were people still doing the shots. It just makes her wonder why was everything doing something like this and it can still happen. To her it didn't really make sense. After she found out that you can still get COVID after this thing she thought well what's the point. She just thought that she would let Pfizer know about what she experienced and that this was a lot worse than when she had the flu shot with the side effects. The flu shot was minor compared to this thing, the COVID vaccines, she felt like she almost could of died. This was most definitely by far a lot worse. She would rather have the flu shot and have a minor thing than this one this was bad. She doesn't know what was in it or what caused her to have this total reaction where she couldn't breath and it was bad. She really doesn't want to do this again either. She doesn't know if there was something in this one or whatever, but it doesn't like her big time. She doesn't know if Pfizer has heard of this where people had trouble breathing after they got this done but she kind of wonders. She listens to the news and on there you don't really hear any side effects caused or how people are dealing with the symptoms. Vaccine was not administered at military facility. Vaccination facility, it was a clinic, well it was between that and the hospital that was connected to the clinic so kind of right inside the hospital area going to clinic, maybe it was the hospital. The adverse events required a visit to a physician's office because she got to the point to where she couldn't breathe. She was even having trouble walking across the parking lot so she ended up going in because she couldn't breathe. No relevant tests done. The outcome of the events "she started to feel like her lungs were starting to close up and her nose closed up completely" was recovering and unknown for the other event. Follow-up attempts are completed. No further information is expected.
67 2021-04-28 headache slight ache in left arm; headaches; surgery is hopefully a mitral valve repair; This is a spontaneou... Read more
slight ache in left arm; headaches; surgery is hopefully a mitral valve repair; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203) intramuscular, on left arm, at the age of 67-year-old, on 26Feb2021 5:45pm, single dose, for covid-19 immunisation. Medical history included asthma and Allergies. Concomitant medications were not reported. On 27Feb2021, the next morning when she woke up, she had like a slight ache in her left arm and then everything was fine. She clarifies she was getting headaches after the first injection but she didn't know if it was from the vaccine or not. The headaches were not that severe. She took Tylenol and the headaches kind of went away. The patient found out that she had to have a surgery on 29Mar2021 and was subsequently moved on 15Apr2021. It was determined her surgery was going to happen after receiving the second vaccine. The surgery is hopefully a mitral valve repair. Outcome of headache and slight ache in her left arm was recovered in 2021 while it was unknown for mitral valve disease. No follow-up attempts are needed. No further information is expected.
68 2020-12-31 headache, fatigue, chills on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amoun... Read more
on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amount swelling R hand --I iced and took acetaminophen. By Dec 25, hand very swollen and painful with decreased ROM all fingers
68 2021-01-02 cough, throat irritation After receiving vaccine, c/o burning throat, coughing, face itching, hot flashes.
68 2021-01-02 sleepiness, fatigue Exhaustion Sleepiness Dizziness Joint pain
68 2021-01-03 fever Low Grade fever, Diarrhea
68 2021-01-04 fever, headache, nasal congestion, throat pain, chills arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle... Read more
arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle and joint pain; chills; low grade fever 99.7; sore throat; congestion; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 3 ug/ml) Batch/lot number: EL1284, on 29Dec2020 12:33 single dose on left arm for COVID-19 immunization. Medical history included Blood pressure high which diagnosed a long time ago, probably when she was 45 years old, though it could have been when she was 42 or 43, probably earlier, 25 years ago, so put when she was 42; hemochromatosis diagnosed about 25 years ago; Arthritis; Cluster headaches; low thyroid and she didn't take medication for this, it wasn't low enough; COVID-19 in Mar2020. Concomitant medication was none. The patient received the Pfizer covid vaccine yesterday (29Dec2020) and she called the line to report the side effects today. She said she had covid around the Easter time and donated her plasma also for antibodies. She said after getting the vaccine yesterday she was feeling worse, have a really bad headache, teeth ache, arm was hurting woke up due to that in the night, really bad headache, muscle and joint pain, chills , low grade fever 99.7 , sore throat and congestion. The patient received the vaccine through work, and was not prescribed it from a provider. She had her shot at 12:33PM yesterday (29Dec2020), after lunch. Her vaccine was given to her at the hospital where she worked, which was not a military hospital. Her side effects were that she developed a headache, also her teeth were aching, and then last night around 04:00AM in the morning she woke up with a very sore arm and worse headache. She said she also had muscle and joint pains, chills, and fever. She said now she still had a headache, and still didn't feel good. Treatment received for the events included Ibuprofen and Tylenol. Ibuprofen was clarified to being generic Ibuprofen prescription in a pharmacy bottle with EXP 3 09Mar2021 and NDC: 67877032005. She said that the strength of this medication is 600mg, and she just took one last night by mouth at about four in the morning. She says she also took Tylenol before bed, 500mg, this is the name brand product. UPC/LOT/EXP: unknown, she didn't have it with her she said it was in date and was brand new, in to go packs. She said that her teeth aching was gone, she still had her headache, muscle pain, fever, and her arm hurt. She said she did take another Tylenol a half hour ago or 45 minutes ago. Her low grade fever temperature was 99.7 degrees Fahrenheit. She had COVID-19 before, she tested positive for COVID at Easter time, this was in March, they did a PCR nasal swab. She had two positive tests and then a negative test because they had to retest her to get plasma, she had to be negative before she could get plasma. She also had an antibody test a couple months after she had COVID, that showed she had 27 antibodies. She had COVID, then a couple of weeks later she gave plasma, and then a few weeks later had the antibody test that showed she had the 27 antibodies. The outcome of teeth ache was resolved. The outcome of headache, muscle pain, fever, and her arm hurt was not resolved. The outcome of other events was unknown.
68 2021-01-04 headache, fever, fatigue, chills headache; nausea; vomiting; chills, rigor; fever; fatigue; This is a spontaneous report from a conta... Read more
headache; nausea; vomiting; chills, rigor; fever; fatigue; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the left arm on 24Dec2020 at 07:30 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included penicillin allergy from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing and a thyroid disorder from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took iodine for an unknown indication and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Dec2020 at 15:30, the patient experienced headache, nausea, vomiting, chills, rigor, fever and fatigue. No therapeutic measures were taken as a result of the events. The clinical outcome of the headache, nausea, vomiting, chills, rigor, fever and fatigue was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
68 2021-01-04 cough, throat pain positive for Covid with symptoms; positive for Covid with symptoms; positive for streph; positive fo... Read more
positive for Covid with symptoms; positive for Covid with symptoms; positive for streph; positive for influenza; This is a spontaneous report from a contactable physician and nurse. A 68-year-old female patient received bnt162b2, via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive for COVID with symptoms, positive for streph and positive for influenza in Dec2020. Additional Context: caller stated that she had a patient that got Covid vaccine on 17Dec2020 who was complaining of muscle aches, no fever, sudden loss of taste and smell in the last 24 hours, sore throat and a cough. Stated that she cannot attribute the cough to the vaccine. Stated that she was screened for COVID, streph and influenza. Stated that she was positive for covid and streph. Stated that she does not think that and wanted to know if the vaccine would cause a positive from a rapid test. Outcome of the events was unknown. The Lot/Batch and expiry date has been requested.; Sender's Comments: The reported positive for COVID with symptoms after immunization with BNT162B2 is considered related to the suspect, BNT162B2.
68 2021-01-07 chills, headache, malaise 1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight he... Read more
1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness, shakes, overall malise, chest tightness. Later that day, mild diarrhea, mikd nausea. Day 3- woke with wheezing. Symptoms all continued for next 10 days off and on. The lip, tongue seemed to get shorter and shorter in duration. Also has mouth watering. Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec. Back to urge t care day 6, Ed day 8. Day 14 abd 15 awful chills, muscke ache and shaking.
68 2021-01-07 runny nose, fatigue, cough I tested positive for COVID 9 days after receiving the vaccine; I tested positive for COVID 9 days a... Read more
I tested positive for COVID 9 days after receiving the vaccine; I tested positive for COVID 9 days after receiving the vaccine; Rhinorrhea; aches; fatigue; cough; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of the two reports. A 68-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the left arm on 21Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included hypertension. The patient had no known allergies. Concomitant medications included losartan (LOSARTAN), amlodipine (AMLODIPINE), and atorvastatin (ATORVASTATIN). On 28Dec2020, the patient had rhinorrhea, aches, fatigue, and cough. The patient had no COVID prior vaccination, and when tested post vaccination showed a positive result. It was reported that the patient was tested via nasal swab (PCR SARS) and showed positive for COVID on 30Dec2020, 9 days after receiving the vaccine. The patient had no other vaccines in four weeks. No treatment was administered for the events. The events had not resolved. Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events drug ineffective and SARS-COV-2 test positive cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001246 Same reporter, same drug, similar events, different patients.
68 2021-01-07 headache, productive cough, fatigue, chills Immediately sore right arm lasting approximately 1 day. Then after initial dose on the second day af... Read more
Immediately sore right arm lasting approximately 1 day. Then after initial dose on the second day after first injection, I began with chills, headache, fatigue, body aches. By the second day after initial dose, I began with mucus cough and same symptoms with chills, headache, fatigue and body aches. I took Tylenol, cold and cough medication. It is the third day after injection, symptoms same, but slightly better, still extreme fatigue and body aches and chills and I took an Proventyl inhaler as needed. Note, I do not take Proventyl inhaler on a regular basis, I just felt the need as I was beginning to have a lot of bronchial mucus. The inhaler seems to help. I am waiting it out and did not contact my family physicians. I am hoping I will feel better soon. Still taking OTC medications and Tylenol, fluids and rest.
68 2021-01-07 fatigue In the evening on the day of the vaccine and the following day my arm was sore and then my entire bo... Read more
In the evening on the day of the vaccine and the following day my arm was sore and then my entire body. Body was so sore that I had to take med to sleep. It is early Friday morning now and I have been so tired and hurting that I have slept most of the week (4 days). I don't often take immunizations as they kick in my rheumatic/psoriatic arthritis so badly and I hurt so badly and can't do anything. I was hoping that this immunization would be different as it's action is supposed to be different. I am still planning on getting the second shot as it is so important:especially due to my age and other conditions.
68 2021-01-07 cough, chills, headache, nasal congestion, fatigue Initial right arm soreness. Second day after initial dose. chills, headache, fatigue, stuffy nose, c... Read more
Initial right arm soreness. Second day after initial dose. chills, headache, fatigue, stuffy nose, cough, with lots of mucus and cough. Taking Tylenol, OTC cold medication and inhaler as needed. Waiting it out with rest, fluids, medication.
68 2021-01-07 headache Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left... Read more
Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; This is a spontaneous report from a contactable consumer, the patient. A 68 -year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 29Dec2020 at 02:30 PM, (at the age of 68 -years-old) as a single dose, dose number=1 for COVID-19 vaccination. Medical history included hypothyroidism and osteopenia. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxin and citalopram within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 02Jan2021, the patient woke up with a red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea. The patient was treated for red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea with diphenhydramine (BENADRYL) 50 mg x 1. The clinical outcome of red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
68 2021-01-07 chills, headache, fever woke up with 100.5 fever, head ache, chills , generalized body aches, stomach ache, Called my work,... Read more
woke up with 100.5 fever, head ache, chills , generalized body aches, stomach ache, Called my work, they ordered, rapid Covid 19 test, waited for 3 hours and came back negative, but I'm having fever 100.3 for two nights and 99.0 at day time, with head ache and stomach ache,
68 2021-01-09 fatigue, chills Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), ab... Read more
Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), abdominal cramping, loose stool x 5 over 48 hours. Extreme fatigue (over 5 days)
68 2021-01-10 throat irritation, cough, throat pain, sleepiness Burning/pain in throat, itching around mouth, wheezing, coughing, and BP 195/100. Taken to the ER, ... Read more
Burning/pain in throat, itching around mouth, wheezing, coughing, and BP 195/100. Taken to the ER, received epinephrine breathing treatment and Benadryl Observed for 2 hours then discharged. Slept most of the following day.
68 2021-01-10 chills, fever Chills nausea body aches dizziness fever
68 2021-01-11 fever Sore arm Low grade fever between 101-102 F Really bad body aches Nausea and vomiting that lasted 24 ... Read more
Sore arm Low grade fever between 101-102 F Really bad body aches Nausea and vomiting that lasted 24 hours Fever has continued in the afternoons
68 2021-01-11 chills, fever developed fever, aches, chills in the middle of the night after receiving the vaccine. did not repo... Read more
developed fever, aches, chills in the middle of the night after receiving the vaccine. did not report to work the following day
68 2021-01-11 malaise, chills, fatigue moderate, and intermittent nausea; lack of appetite; fatigue; malaise; sometimes chills; This is a s... Read more
moderate, and intermittent nausea; lack of appetite; fatigue; malaise; sometimes chills; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. A couple of hours after she received the Pfizer-BioNTech Covid-19 Vaccine last 21Dec2020, she started to experience moderate, and intermittent nausea, lack of appetite, fatigue, malaise, and sometimes chills; all on 21Dec2020. She said that the worse of all side effects she's experiencing was nausea. HCP also said that she was still experiencing the side effects until now. She also mentioned that she got tested for Covid, and results came back negative. However, she said that she will get tested again just to make sure she did not have the virus. The events were reported as non-serious. The outcome of events was not resolved. Information on the Lot/Batch number has been requested.
68 2021-01-12 chills, headache, fever Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stom... Read more
Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stomach pain, diarrhea Still experiencing fever and diarrhea.
68 2021-01-13 chills, sweating 1) Ice cold toes & feet, sweat in toe area of socks 2) confusion, 3) chills
68 2021-01-13 chills, fatigue Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the fi... Read more
Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the first day after injection and once on the second day after injection. Other S.C. were fatigue, muscle aches, chills, indigestion and sore arm. No fever noted.
68 2021-01-13 fatigue Severe abdominal cramps moving up towards diaphragm. Complete exhaustion. Nausea
68 2021-01-13 headache, fever Stomach (Abdominal pain); Nausea, headache, feverish, but no temp; minor Body aches. Began around 9:... Read more
Stomach (Abdominal pain); Nausea, headache, feverish, but no temp; minor Body aches. Began around 9:00 A.M. (2 hrs After injection). Nausea & other symtoms gone by A.M. 12-29-20.
68 2021-01-13 fatigue Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metal... Read more
Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metallic-type taste and felt tingling around my mouth. I had been sitting in the post-vaccine observation area during this time looking at my telephone. I approached the nurse's desk and reported what I was experiencing and was taken to another room where I was put in a wheelchair and vital signs were taken. By now I think I became very anxious and fearful and my heart felt like it was pounding at 104. My BP went to 188/79 which is high for me and I felt SOB. I truly think the VS symptoms were related to anxiety, but I continued to have the taste in my mouth and my tongue felt like sandpaper. I was given 50 mg BENADRYL and observed for 30 minutes. After that amount of time, I felt better and safe to leave the hospital. Today, 1/14/2021, I have felt excessive tiredness and mentally dazed with diarrhea. No temperature, slight nausea this morning, and no vomiting. My left arm is only moderately sore. Now, at 7:30 pm I am feeling better and feel that I can work tomorrow. Honestly do not know if it was an adverse reaction or excessive anxiety. I do not have anxiety disorder.
68 2021-01-13 fatigue, fever Tired, low grade (100.9) temp
68 2021-01-13 productive cough neck stiffness; coughing with production of white mucous; felt like she couldn't breath with tightne... Read more
neck stiffness; coughing with production of white mucous; felt like she couldn't breath with tightness for about a half hour; felt like she couldn't breath with tightness for about a half hour; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot /batch and expiration date unspecified), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the vaccine yesterday (07Jan2021) and that a couple of hours later she began to experience neck stiffness, coughing with production of white mucous and felt like she couldn't breath with tightness for about a half hour. The patient was asking if this was normal. Outcome of events was unknown. Information on the lot/batch number has been requested.
68 2021-01-16 chills, headache, fever chills, headache, body aches, spaced out feeling, loss of appetite, sick stomach, 100.5 fever for 2 ... Read more
chills, headache, body aches, spaced out feeling, loss of appetite, sick stomach, 100.5 fever for 2 days-this felt similar to how I felt when I had Covid 19 March-April.
68 2021-01-17 respiratory tract congestion, cough eosinophil count is 12.2%; Congestion; rhinitis; Cough; This is a spontaneous report from a contacta... Read more
eosinophil count is 12.2%; Congestion; rhinitis; Cough; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 21Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who is an MD received the COVID vaccine on 21Dec2020. She quickly developed rhinitis, cough, and congestion which have persisted. Her eosinophil count is 12.2%. She received a Medrol pack, but it did not relieve her symptoms. She has delayed her second injection for now. The outcome of the events was unknown. Information about lot/batch number has been requested.
68 2021-01-17 headache severe headache soon after vaccination, vomiting, nausea and diarrhea also
68 2021-01-18 fatigue, headache, chills Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , h... Read more
Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , headache joint pains , muscle pains , chest pains and nausea as well as Fatigue . I started taking Tylenol 500mg po q 6 hrs and that improve the sxs. The site of the injection was extremely red and swollen as well as lymphadenopathy underneath the left arm ( site of injection). The next day ( sunday) I noticed a swelling underneath the axilla going on top of the bra with blood exudate and looked as if I had bumped an object. The weakness continued during the next week and slowly the tiredness got better ( TOOK AT LEAST 7-10 DAYS).
68 2021-01-19 headache, fatigue, chills, body temperature increased 1/15 - HAD SLIGHT HEADACHE AND BODY ACHES IN LATE EVENING AND CHILLS AND TEMP 100.1 AT 10PM. 1/16- ... Read more
1/15 - HAD SLIGHT HEADACHE AND BODY ACHES IN LATE EVENING AND CHILLS AND TEMP 100.1 AT 10PM. 1/16- 6AM HEADACHE; 10AM TEMP 100.2 WITH BODY ACHES AND VERY TIRED; 12 NOON VOMITED; 3PM TEMP 101.2. BODY ACHES, TIRED AND CHILLS. HAD SMALL AMT OF BLOOD IN STOOL (STOPPED ADVIL); 5PM TEMP 100.1 1/17 - 10AM TEMP 99; 11AM TEMP 98 AND REMAINED AFEBRILE WITH HEADACHE. 1/15 2:40PM- ADVIL 200MG+TYLENOL 500MG; 9:30PM 400MG ADVIL 1/16 6AM ADVID 400MG; 3PM TYLENOL 500MG 2 TABS 1/17 7AM TYLENOL 500MG 2 TABS
68 2021-01-20 fatigue Exhausted Light headed
68 2021-01-20 chills, fatigue, fever Nausea, joint pain, fever, chills, fatigue. 2 days duration
68 2021-01-20 headache, malaise Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since... Read more
Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since admission for Sepsis (6/2020), chronic headaches, right sided HL, GAD, NA fatty liver disease, Osteoporosis p/w headache back of her head after receiving the COVID immunization. Per Daughter CO reported feeling unwell while leaving the vaccination clinic. They wet back to the clinic and CO laid down for a while and was given a snack. She then reported she felt well and wanted to go home. Between the clinic and the car she felt unwell again and was directed to the ED. Per CO HA at back of head along with mild dizziness initially. Dizziness has now resolved. She took Tylenol at 1100 today for HA but does not remember if she took any more Tylenol since then. CO does not remember when she last ate. Per Daughter she last ate at 1030 today. She was supposed to have lunch at one but someone forgot. CO has a family member with her at all times since her cognitive impairment this past summer. She reports regular HAs are usual for her ever since her "brain injury" (CO hospitalized for Sepsis July 2020) Denies dizziness, denies visual changes, no photophobia. Given Acetaminophen and some food. RBS: 94 CO reports that the headache is now at the front of her head. CO eating a sandwich, calm, in a good mood. Feels much better. Headache resolved prior to discharge.
68 2021-01-20 malaise, headache Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since... Read more
Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since admission for Sepsis (6/2020), chronic headaches, right sided HL, GAD, NA fatty liver disease, Osteoporosis p/w headache back of her head after receiving the COVID immunization. Per Daughter Pt reported feeling unwell while leaving the vaccination clinic. They wet back to the clinic and Pt laid down for a while and was given a snack. She then reported she felt well and wanted to go home. Between the clinic and the car she felt unwell again and was directed to the ED. Per Pt HA at back of head along with mild dizziness initially. Dizziness has now resolved. She took Tylenol at 1100 today for HA but does not remember if she took any more Tylenol since then. Pt does not remember when she last ate. Per Daughter she last ate at 10:30 today. She was supposed to have lunch at one but someone forgot. Pt has a family member with her at all times since her cognitive impairment this past summer. She reports regular HAs are usual for her ever since her "brain injury" (Pt hospitalized for Sepsis July 2020) Denies dizziness, denies visual changes, no photophobia. Given Acetaminophen and some food. RBS: 94 Pt reports that the headache is now at the front of her head. Pt eating a sandwich, calm, in a good mood. Feels much better. Headache resolved prior to discharge.
68 2021-01-21 malaise, fever, chills, fatigue Chills, fever to 100.7, mild nausea, malaise, fatigue all resolving in 24 hours. A transient light r... Read more
Chills, fever to 100.7, mild nausea, malaise, fatigue all resolving in 24 hours. A transient light rash (hives) noted at bedtime 48 hours after injection, totally resolving by morning. Not sure this were real adverse advents,but very happy to have had a robust reaction indicating it's working! !!
68 2021-01-21 headache, fever I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightnes... Read more
I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightness. I say I was fine until 3-4 hours later, I had extreme headaches. At 430pm, I still had the headaches and I took Tylenol 500mg. At night my headache got worse and it felt like I had the flu. I then went to bed and when I woke up my left arm felt intense like hornets and it was swollen. I then took another Tylenol and Ibuprofen 600mg. At 4am, I felt awful and horrible. I had joint pain with aches, felt nauseated. I called my PCP and he told me to take Prednisone 10mg. My fever was 101.4F. By the night my fever was gradually coming down and it was 102F. By the next day I felt much better. I also had Covid-19 on March 2020 and also got tested for antibody test in July 2020. I spoke with my PCP and he is recommending I do not take the 2nd dose injection.
68 2021-01-21 headache LOSS OF TASTE, HA
68 2021-01-21 chills, fatigue, headache headache( did not take anything yet) chills tiredness muscle/joint pain injection site pain
68 2021-01-21 throat pain my face started to feel tight, feeling as through I was getting a sore throat, lips and tongue start... Read more
my face started to feel tight, feeling as through I was getting a sore throat, lips and tongue started tingling. All symptoms were minor and lasted about 3 hours.
68 2021-01-22 malaise, chills 30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudde... Read more
30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudden felt weak, lightheaded, trembly, with chest tightness and a need to lay down. The biggest problem was that my eyes became strangely affected, like there were shutters being opened and closed in rhythmic waves inside my eyes. They were also very photosensitive and blurry. My whole head felt wrong. drove me home, (I could not have driven). This lasted several hours. I had chills and stayed laying down with my eyes closed. By the end of the day I felt mostly recovered. This series of events recurred 6 days later, on Jan. 20th. This time it also lasted most of the day, but I continued feeling moderately unwell the next day, and today it continues. I feel weak and unsteady. My eyes are better but not entirely. They ache and feel insecure. I am not currently feeling up to any activities besides resting.
68 2021-01-23 malaise, fatigue Malaise and fatigue x 48 hours
68 2021-01-24 headache My reaction did not require medical attention, but I happened to have an appt. with my doctor and me... Read more
My reaction did not require medical attention, but I happened to have an appt. with my doctor and mentioned it to her. She thought I should mention it to you in case it is part of a larger pattern. I had normal reactions of arm pain and headache (not serious) since I had the shot. I have also been experiencing sporadic numbness and tingling in my arm down to my fingers. It does not last long but it comes and goes. It has been three days since the shot and all symptoms have decreased.
68 2021-01-24 headache Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aph... Read more
Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards. In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse. With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission. On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
68 2021-01-24 chills, headache, fatigue, cough, body temperature increased The only reaction I had with the first vaccine on 12/18/20 was fatigue the second day following the... Read more
The only reaction I had with the first vaccine on 12/18/20 was fatigue the second day following the vaccination. 12/18/20. On 12/2820 I developed a deep cough and a temperature of 100.6. I tested positive for Covid. I quarantined for 10 days and was ill for approximately 5 of those days. I contacted my pulmonologist who researched the data and determined if I was afebrile and did not have body aches and was feeling ok I could take 2nd vaccine. If not I should wait a week. Since I was not experiencing S&S of Covid and felt fine I took 2nd vaccine on 1/8/2021. Late the night of the injection 1/8/2021 I developed a deep consistant cough, a temp of 100.2, chills, headache, and fatigue. By the second day my temp was 99.8 , cough was unchanged and fatigue was unrelenting. My temp continued to decrease with time until I was afebrile the week of the 18th. By the 22nd the fatigue was much improved and the cough was not as persistent. Today, 1/25/2021 my only complaint is the deep cough .
68 2021-01-24 chills chills,diarrhea,body,aches,no appetize
68 2021-01-25 fever, headache, fatigue, chills About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hur... Read more
About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hurt to lift my arm. Also had some slight nausea and headache. Took Ibuprofen helped some. Next day still felt off, arm still extremely sore, body aches, headache, fatigue. I continued with the Ibuprofen alternating with Tylenol. Finally felt better by Sunday and was able to return to work on Monday.
68 2021-01-25 fatigue No appetite. Diarrhea fatigue Lasted 7 days.Then normal.
68 2021-01-25 sweating, sleepiness, chills Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vac... Read more
Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21 @ 0630, at 2030 developed generalized aching, chills, weakness and sleepiness. Woke up at 0300, went to bathroom and passed out returning to bed. Awakened soaked in perspiration. Had dry heaves and 1 loose stool. Felt weak and sleepy until 0700, then felt mostly normal. Symptoms relieved by 1000. No other symptoms after that".
68 2021-01-26 headache .On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No ... Read more
.On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No outward sign. Symptoms continued throughout the rest of the day. Mild headache, some nausea. No difficulty breathing, no fever, no hives or rash. General uneasy feeling. Next morning awoke with "fullness "in ears, with some ringing. Facial symptoms would come and go. On Sunday, two days after vaccine, I felt much better, facial symptoms better, ears still felt plugged. Could ear fine. On Monday , symptoms pretty much gone. I was in contact with primary physician through email/phone message. No treatment was necessary.
68 2021-01-26 fatigue, headache, fever 6 days after vaccine I had fever, nausea, headache, stiff neck, fatigue. Symptoms lasted 2 days and... Read more
6 days after vaccine I had fever, nausea, headache, stiff neck, fatigue. Symptoms lasted 2 days and are improving.
68 2021-01-26 throat irritation Burning sensation in upper stomach, chest, throat. Rapid heartbeat
68 2021-01-26 chills, throat pain chills; Sore throat; some aching, like body aches; joint tenderness; some swelling at the injection ... Read more
chills; Sore throat; some aching, like body aches; joint tenderness; some swelling at the injection site; arm tenderness; This is a spontaneous report from a contactable consumer reported for self. This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 13:30 on Arm Left at single dose (lot: EK9231, Expiry: 30Apr2021) for covid-19 immunisation. Give her a follow up appointment for a second dose, that will be 02 Feb at 1:20 PM. Medical History included arthritis and had surgery for right knee replacement 6 years ago (2015). They are trying to figure out, she has water in her ear she has had CT scans recently trying to check for any problems that could be corrected surgically and that was all clean. She has had a mammogram, she was not sure about the mammogram yet but she thinks they would have called her if there was a problem with that. Historical vaccine included Just mild stuff with the flu vaccine for immunisation on occasion she has had similar reactions that were very mild with the flu vaccine and last year she had none of that at all. She says when she has had any other vaccine, she had no reaction other than maybe a slightly sore arm. No other products. She did have some mild side effects. She was really glad she got this shot. She said she had experienced some chilling on 13Jan2021, these are all very mild symptoms. She had a sore throat on 13Jan2021, some aching, like body aches on 13Jan2021 and joint tenderness on 13Jan2021. She just got chilled every once in a while. It was not very bad. She said the sore throat had persisted about the same, but the coffee helped. She was having some swelling at the injection site that was about the same as when it began on 13Jan2021. She was having some arm tenderness on 13Jan2021. She did not have any adverse reactions yesterday (12Jan2021) she was so excited to get it. Outcome of the events was not recovered.
68 2021-01-26 headache, fatigue immediate dizziness and elevated heart rate after vaccine, and somewhat elevated blood pressure afte... Read more
immediate dizziness and elevated heart rate after vaccine, and somewhat elevated blood pressure after an hour felt better, went home to bed with fatigue, slight nausea and headache
68 2021-01-27 fatigue, chills Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injectio... Read more
Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injection; couldn't lift her arm at all; left eye twitching; Chills; Nausea; no appetite; whole body ache; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 11Jan2021 5:15 PM at a single dose on arm for COVID-19 immunization. Medical history included ongoing shellfish allergy from 1975 (she carries epi pen), ongoing iodine allergy from 1975 (she carries epi pen), ongoing Mitral valve prolapse (for 20 years), blood pressure high, and cholesterol. The patient had mitral valve prolapse for about 20 years now. They are just watching it now. She just saw the cardiologist, and had an echo done. If the symptoms worsen, they will proceed. Concomitant medications included diltiazem for blood pressure high and atorvastatin for cholesterol, both from an unspecified date and ongoing; she has been on these medications for 30 years now. On 11Jan2021, the patient experienced facial tingling, immediate pain in arm from injection, couldn't lift her arm at all, left eye twitching, chills, nausea, no appetite, whole body ache, tired, whole body trembled, nervous. On 12Jan2021, the patient experienced back pain. The patient explained that on 11Jan2021, evening at 5:15pm, she received her first COVID 19 vaccine. The Pfizer vaccine was being given out at that time. She has shellfish and iodine allergies. So, they made her sit and wait 30 minutes after being injected. One of her daughters took her. On the drive home, a few minutes after leaving she developed facial tingling. At first, she thought nothing of it. She did have immediate pain in her arm from the injection. By the time she got home, she couldn't lift her arm at all. It was that painful. The next morning, she couldn't lift arm, and if she tried, she would be in pain. Also, her left eye started twitching right away also. That night she really noticed it. It was not a constant twitching. She thought at first it was because she was tired or from the pain in her body. But then she noticed the next day it was still doing that. It was still twitching. It is not constant, but it was here and there. She still had it on 13Jan2021, but so far nothing at the day of report (14Jan2021). She also had chills. She had on double clothes, and coverings on her feet and hands. The chills wouldn't go away. Her whole body trembled. On 13Jan2021, Wednesday morning, they went away. She experienced nausea and no appetite. Her whole body ached. It was so brutal. The problem was with her left eye. It didn't twitch constantly, but it got her nervous. She is pretty sure she is going to refuse the second dose. She has heard that the 2nd part is when most people have the worst side effects. So, she is not comfortable getting it. She also got back pain. It wasn't severe, but it was there. She is against getting the second shot. She stated that she is a medical assistant at a pediatric office. She doesn't have a prescribing doctor. She got it (vaccine) because of her age. She was advised to get it as she was around patients. Work gave them the option. The inability to move her arm ended in the middle of night at 4 am 14Jan 2021. She noticed she could move her arm. Her second dose is scheduled for 01Feb2021 at 8:45 am. She does work in a pediatric office. If the second part of side effects are worse, then she doesn't want to take the chance. The eye has her concerned. Outcome of the events were as follows: facial tingling recovered on 11Jan2021, immediate pain in arm from injection recovered on 13Jan2021, chills recovered on 13Jan2021, nausea recovered on 13Jan2021, no appetite recovered on 13Jan2021, whole body ache recovered on 13Jan2021, couldn't lift her arm at all recovered on 14Jan2021, back pain was recovering, while outcome for events left eye twitching, tired, whole body trembled, and nervous, was unknown. Information about lot/batch number has been requested.
68 2021-01-27 headache, chills Debilitating headache, nausea, chills, aches, pains, light-headed, disorientation, diarrhea, more
68 2021-01-27 cough Patient presented to the ED on 1/21/21 for evaluation of SOB stating her husband tested positive for... Read more
Patient presented to the ED on 1/21/21 for evaluation of SOB stating her husband tested positive for COVID earlier that week and she has been around him. The patient states her symptoms started 3-4 days prior to presentation. She admits to cough, nausea, and an episode of vomiting the day of presentation. She had been intermittently using her husband's oxygen prior to presentation which she says has helped with her symptoms, but does not use oxygen at baseline. Upon presentation the patient's oxygen saturation rate on room air is 89%. Patient was placed on 2L oxygen via nasal cannula and then was saturating in the mid 90s. CXR demonstrated bilateral patchy infiltrates in the ED which the ED physician felt to be consistent with COVID infection. The patient's rapid COVID test resulted as positive. The patient was admitted to the hospital for further management of hypoxia related to COVID infection. The patient remains hospitalized on the day of report submission (1/28/21)
68 2021-01-28 headache Shakes, tongue and lip sweeping, pain in stomach and headache
68 2021-01-28 fever, chills shore arm, fever chills body aches nausea and vomiting
68 2021-01-28 headache, fatigue tiredness; headache; muscle aches; nausea; dizziness; This is a spontaneous report from a contactabl... Read more
tiredness; headache; muscle aches; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283), via an unspecified route of administration on 11Jan2021 at 11:00 AM at a single dose on the left arm for COVID-19 immunization. Medical history included Barret's esophagus and glaucoma both from an unknown date and unknown if ongoing. Concomitant medication included dorzolamide;timolol maleate (manufacturer unknown) and pantoprazole (manufacturer unknown). The patient did not have COVID-19 prior to vaccination. The patient did not have other vaccines in four weeks. The patient previously took codeine and experienced allergies. The patient experienced tiredness, headache, muscle aches, nausea and dizziness all on 12Jan2021 at 03:30 PM. The patient did not receive any treatment for the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
68 2021-01-29 headache Experiencing headache and shortness of breath every day, for the last 5days. Using albuterol; had n... Read more
Experiencing headache and shortness of breath every day, for the last 5days. Using albuterol; had not been necessary for months.
68 2021-01-31 fever, fatigue, headache Fatigue; joint discomfort; mild fever; mild headache; This is a spontaneous report from a contactabl... Read more
Fatigue; joint discomfort; mild fever; mild headache; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via an unspecified route of administration in left arm on 15Jan2021 at 08:30 AM at single dose for COVID-19 immunization. Medical history included CAD (coronary artery disease), mild COPD (chronic obstructive pulmonary disease) and GERD (gastroesophageal reflux disease). Patient had Covid prior vaccination. Patient was not pregnant. Patient has no known allergies. No other vaccines in four weeks. Concomitant medications included rosuvastatin calcium (CRESTOR), carvedilol (COREG) and vitamins (unspecified). On 16Jan2021 at 01:00 PM, the patient experienced fatigue, joint discomfort, mild fever, and mild headache. Patient did not receive treatment for the events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
68 2021-01-31 headache, malaise feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was... Read more
feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was spinning; there is not enough spit in my mouth. It's very dry; I walked very slowly; slight headache; My blood pressure now is 137/93. It was high this morning; felt lousy like I had the flu; felt like I was fainting; This is a spontaneous report from a contactable consumer. A 68-years-old female patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included transient ischaemic attack (I had a TIA prior). The patient's concomitant medications were not reported. The patient experienced "feeling a little woozy/dizzy" on an unspecified date with outcome of unknown, "my head was sideways and every time I would raise my head the room was spinning" on an unspecified date with outcome of unknown, "there is not enough spit in my mouth, it is very dry" on an unspecified date with outcome of unknown, I" walked very slowly" on an unspecified date with outcome of unknown, "slight headache" on an unspecified date with outcome of unknown, "my blood pressure now is 137/93. it was high this morning" on an unspecified date with outcome of unknown, "feelt lousy like I had the flu" on an unspecified date with outcome of unknown, "felt like I was fainting" on an unspecified date with outcome of unknown. Reaction description by the reporter:" I had no pain, slight headache. My blood pressure now is 137/93. It was high this morning when I talked with the triage nurse. I had the shot/vaccine (first dose) on Friday. I feel better today than yesterday. Friday I felt fine. I got symptoms yesterday. When I woke up yesterday. I was feeling a little woozy, I always stretch slowly in bed. I slowly raised myself on the bed but before I got up my torso fell backwards. I felt like I was fainting. The room was spinning. All day yesterday I did not drive. I walked very slowly. I was holding onto the wall. I felt lousy like I had the flu. I would lay down for 20 minutes, watching tv. My head was sideways and every time I would raise my head the room was spinning. Also there is not enough spit in my mouth. It is very dry. I had a slight headache. So I did not bother but no headache today. I supposed to get my 2nd dose on 02Feb2021. The action taken was not applicable. Information on the Lot/Batch number has been requested.
68 2021-02-01 influenza like illness Flu like symptoms; This is a spontaneous report from a contactable consumer reported for herself. A ... Read more
Flu like symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at Left arm on 12Jan2021 16:00 at SINGLE DOSE for covid-19 immunization. Medical history included Hypo-Thyroid and gastrooesophageal reflux disease. No known allergies, not allergies to medications, food, or other products. The patient received other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced non-serious flu like symptoms three days after vaccine on 15Jan2021 at 04:00 PM, lasted for 4 days. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid (Nasal Swab) tested on 19Jan2021 post vaccination but the result was pending. The outcome of the event was recovering.
68 2021-02-01 headache Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below... Read more
Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below elbow on top of arm; minor soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL-1283 (also reported as "FL-1283"), intramuscular on left arm on 19Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin and dust molds. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. Concomitant medications included Atorvastatin, ergocalciferol (VIT D), Biotin and Glucosamine with MSM. The patient previously took first dose of BNT162B2 (lot number: EK92316) on 29Dec2020 12:45 intramuscular on left arm for COVID-19 immunization. On 19Jan2021 at 16:45, the patient had swelling under the left side of left breast, mild headache, minor muscle pain in left and arms below elbow on top of arm and minor soreness at injection site. Patient was most concerned about swelling. No treatment for the events. The patient had no COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.
68 2021-02-03 headache 2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later devel... Read more
2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later developed headache which increased in intensity and eventually triggered a migraine, severe dizziness making it impossible to sit/stand, muscle aches,nausea. no temperature or chills. The headache lasted all day lasted all day Friday and decreased in intensity by Saturday. With rest, the dizziness resolved by Friday evening. The muscle aches remained mildly for a few days.
68 2021-02-03 headache, malaise, chills Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimm... Read more
Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
68 2021-02-03 headache Hives arm soreness and a headache
68 2021-02-03 chills, fever, headache, fatigue Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate he... Read more
Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate headache, chills, aching (muscles), fatigue, low-grade fever (100.2), mild nausea, sore upper arm Jan. 31: mild headache, mild muscle/joint ache, chills, fatigue, pain at injection site, loss of appetite Feb. 1: mild pain at injection site Feb. 2: all symptoms resolved
68 2021-02-03 throat irritation Patient called into PCP office reporting red rash surrounding her mouth, extending to her chin and d... Read more
Patient called into PCP office reporting red rash surrounding her mouth, extending to her chin and down her neck. Patient also described throat as "scratchy".
68 2021-02-04 headache, chills 6 hrs after injection swelling began and headache (About 9PM). Next morning swelling from shoulder t... Read more
6 hrs after injection swelling began and headache (About 9PM). Next morning swelling from shoulder to elbow & headache, chills, tool Tylenol. No appetite, very loose bowels at 10:00 am, (NOTE: NO fever) headache, chills continued all day & dizziness was added only when I moved my eyes like to glance at something or trying to read . Woke up, all symptoms were gone except a little swelling around injection site. 48 hours after injection, only very little swelling at injection site.
68 2021-02-04 malaise, chills Intestinal pain, chills, generally feeling unwell
68 2021-02-04 fever Resident had fever of 103.1 with body aches but has been resolved afterwards.
68 2021-02-04 fever, chills The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ... Read more
The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
68 2021-02-05 sweating, headache Early morning after vaccine started with headache then nausea and chilling. Chilling all day and ev... Read more
Early morning after vaccine started with headache then nausea and chilling. Chilling all day and evening Fever must have broke about 24 hours or so after with breaking out in a sweat. Symptoms just keep getting worse as the day progressed . Almost 24 hours after the bones just hurt. Today, 2/6/21, two days after vaccination still have nagging headache
68 2021-02-05 headache Headache beginning 5 hours after time of vaccination continuing until 16 hours after vaccination Arm... Read more
Headache beginning 5 hours after time of vaccination continuing until 16 hours after vaccination Arm soreness from 5 hours after vaccination until 36 hours after time of vaccination
68 2021-02-05 fatigue Lightheaded initially. Felt a little nauseous and tired Then went home and experienced vertigo when... Read more
Lightheaded initially. Felt a little nauseous and tired Then went home and experienced vertigo when I turned my head or bent forward. Still having vertigo off and on since vaccine. I have had vertigo before but usually never lasts this long or has felt quite like this.
68 2021-02-05 body temperature increased Low grade temp. 100.2 All over body aches tired/no energy I took 1250mg. Tylenol, 2x's on 2/5/2021 a... Read more
Low grade temp. 100.2 All over body aches tired/no energy I took 1250mg. Tylenol, 2x's on 2/5/2021 and slept most of the day. Today, 2/6/2021 I feel fine. No further symptoms and no further need for Tylenol.
68 2021-02-05 fever, chills, fatigue, headache, influenza like illness, nasal congestion Started with chills fever. Had flu like symptoms,joint pain headaches fatigue achy Just SICK all ove... Read more
Started with chills fever. Had flu like symptoms,joint pain headaches fatigue achy Just SICK all over. Nasal congestion.
68 2021-02-06 fever, chills, sweating, throat pain After 72 hrs extreme sore throat/ fever as high as 102.8 , muscle aches , chills and sweating still ... Read more
After 72 hrs extreme sore throat/ fever as high as 102.8 , muscle aches , chills and sweating still continuing after 3 days . Called on call doctor and she put me on zpac antibiotics 7pm Feb 6 . With Tylenol and ibuprofen able to get temperature down to 100.1 but goes back up in evening, 102 temp . I feel a little better this morning, temp . 99.8 , still extreme sour throat. On call doctor told me if systems get worse to go to immediate care
68 2021-02-06 fatigue, fever, malaise, chills, headache Beginning about 12 hours after injection, for apporximately 36 hours after injection, I had a fever ... Read more
Beginning about 12 hours after injection, for apporximately 36 hours after injection, I had a fever (high of 101), chills, pounding headache, body aches, vomiting, diarrea. I felt incredibly tired and slept, restlessly, on and off for 24 hours. I was unable to even drink anything for about the first 15 hours. Finally I was able to eat two crackers and tea and take tylenol which took the edge off the headache. All of these sympoms persisted for 36 hours. It was miserable and I honestly have never felt so sick. That is coming from someone who has been through labor, childbirth, c- sections, and several major surgeries. I don't think I could do another vaccine without being supervised in a health care facility to help manage the side effects for the first few days. Also, I had a mild case of Covid beginning November 9, 2020 that lasted about 2 weeks. I was only exposed to one person who had covid that I am aware of. When I was with that person for about 15 minutes, we were masked and 6 feet apart. I do not go anywhere but work and am always masked, as is everone else I work with and we are always at least 6 feet apart.
68 2021-02-06 fever, chills Dizziness, Fever, Chills
68 2021-02-06 headache, influenza like illness Headache. site of Injection. slight nausea. Flu like feeling.
68 2021-02-07 malaise Approx 5-10 min after receiving the injection patient c/o not feeling well, lightheaded, visual migr... Read more
Approx 5-10 min after receiving the injection patient c/o not feeling well, lightheaded, visual migraine (has history of. Assisted to private location and removed some of her winter garments to cool her. She also took in water as she had not drank much that day she stated. Ice pack to the back of neck also applied. Vitals taken and wnl. Affter approx 10 min patient states headache resolved and was feeling slightly better. Observed till symptoms resolved. Denies any resp symptoms during entire process. No swelling anywhere on person.
68 2021-02-07 fatigue, fever Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient's spouse). A 68-ye... Read more
Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient's spouse). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included covid-19 in 2020 wherein the reporter and the patient had it last year. The patient's concomitant medications were not reported. The patient experienced fever with outcome of recovering. She already took TYLENOL to treat her fever. It was queried if the patient can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The patient was a nurse, she got the Pfizer vaccine yesterday on 21Jan2021, that at 3am this morning (22Jan2021), she had a 101 degree temperature, a 100 degree temperature at 8AM and a while ago it was 99.9 degrees at around 9:30 this morning. The reporter wanted to known if these were expected and what they should do. The reporter mentioned that his wife's case was not so bad, states that he himself was in the unit for some weeks. The patient also had fatigue 22Jan2021 with outcome of not recovered. Information about Lot/Batch has been requested.
68 2021-02-07 head discomfort, nasal congestion Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ... Read more
Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ashy/pale complexion. Felt extremely weak in the evening.
68 2021-02-07 headache Patient initially felt dizziness and headache within 15 mins of receiving the vaccine. Blood pressu... Read more
Patient initially felt dizziness and headache within 15 mins of receiving the vaccine. Blood pressure was 180's/96. About 1 hour after vaccine, patient's blood pressure was 160's/90. Around 1pm BP was 201/102. Patient went to EC and was treated with Klonopin and Benadryl. After Klonopin, BP was 150's/80's. Patient was discharged home from EC. BP on 12/23/2021 was 110/60.
68 2021-02-07 headache Pt states she developed a headache aproximatley 15-20 minutes after receiving the vaccine at 12:15. ... Read more
Pt states she developed a headache aproximatley 15-20 minutes after receiving the vaccine at 12:15. Pt states her headache has not gone away and would like to have her vitals taken. Pt's vitals are stable. Pt requested to sit with the crew and monitor her vitals. At 13:10 Pt states her headache is gone. Pt refused transport to hospital.
68 2021-02-07 chills blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still hav... Read more
blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still having some type of reaction; She did have nausea this morning; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received bnt162b2 (BNT162B2; Lot # EL1283) , via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation . Medical history included cataract operation on 10Nov2020, oedema , swelling , brain operation on 2016 , aneurysm (aneurysm that did not rupture and there are 8 coils protecting that) , implantable cardiac monitor insertion , hypertension. Concomitant medication included lisinopril dihydrate (LISINOPRI)Lacetylsalicylic acid (ASPIRIN BAYER), amlodipine besilate (AMLODIPIN) pravastatin sodium (PRAVASTATIN) The patient experienced chills on 21Jan2021 with outcome of not recovered , her lips are a pinkish color as if she is still having some type of reaction on 21Jan2021 with outcome of not recovered , she did have nausea this morning on Jan2021 with outcome of unknown , blood shot right eye on 22Jan2021 with outcome of not recovered , she thinks she had an allergic reaction on 21Jan2021 with outcome of not recovered. The patient received Benadryl, Prednisolone and Ketorolac as treatment. Follow up information has ben requested.
68 2021-02-07 chills, fever, headache, fatigue pain down left arm to wrist and hand (still there); pain down left arm to wrist and hand (still ther... Read more
pain down left arm to wrist and hand (still there); pain down left arm to wrist and hand (still there); unable to open & close left hand until next morning; Headache; occasional chills; fever; fatigue; Mild facial swelling; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263; expiry date: unknown) via an unspecified route of administration in the left arm, on 21Jan2021 at 14:00, at a single dose, for COVID-19 immunization. Medical history included allergies to Sulfa. The patient did not have other chronic health conditions. Concomitant medications included turmeric [curcuma longa rhizome], and ashwagandha. The patient previously took doxycycline and experienced allergies. On 21Jan2021, the patient had mild facial swelling 20 minutes after inoculation, at 14:30 the patient had pain down left arm to wrist and hand (still there), unable to open and close left hand until next morning, headache, occasional chills, fever and fatigue. The patient did not receive treatment for the events. The events were considered non-serious. The patient was recovering from the events.
68 2021-02-08 headache Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain... Read more
Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain and headache. Early evening I developed hoarseness and trouble breathing. Went to Emergency room. They administered IVwith Benedryl; Prednisone; and Pepcid. After an hour my breathing was better and some of the redness on arm was better. I went to physician on 2/5/2021 because of neck pain and was prescribed MethylPrednisolone Tablets, 4 MG. 6 day pack and was on day 3 when the symptoms started.
68 2021-02-08 headache suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support her... Read more
suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support herself to walk around in her home; pain in her upper and lower extremities/ this bilateral upper and lower extremity pain; stiffness and weakness beginning at the shoulders and hips; dull headache; This is a spontaneous report from a contactable healthcare professional. A 68-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 14Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), COPD (chronic obstructive pulmonary disease), previous TIA (Transient ischemic attack) with some residual right sided weakness, CHF (congestive heart failure), osteoarthritis. Had a childhood vaccination history. No Known allergies. Concomitant medications included albuterol, aspirin, atorvastatin, fluticasone, furosemide, hydralazine, ibuprofen, lisinopril, metoprolol, multivitamin, all above were in two weeks (as of 25Jan2021). The patient previously received influenza vaccine yearly, and received her pneumonia vaccines over the last several years, both for immunization and never had a reaction to a vaccine. The patient was not pregnant at time of vaccination. No other vaccine received in four weeks. The patient developed a dull headache on 15Jan2021, one date after the vaccine, but that it resolved after 24 hours on 16Jan2021. On 16Jan2021 at 8:00 AM, the patient developed bilateral proximal muscle stiffness, weakness, and pain in her upper and lower extremities over the course of 1 week. The patient started experiencing this bilateral upper and lower extremity pain, stiffness and weakness beginning at the shoulders and hips and extending distally over several days. Her symptoms started out relatively mild and progressively got worse over the course of 7 days. She presented to the reporting healthcare professional 8 days after her vaccination and she was extremely weak and could not support herself to walk around in her home, the reporting healthcare professional suspect polymyalgia rheumatica. All the events (except dull headache) resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalization due to all the above events for 3 days. The patient had a remarkable response to the treatment of prednisone during her hospitalization. It was unknown if covid prior vaccination. The patient underwent lab tests and procedures, which included COVID tested (COVID test type: Nasal Swab, SARS-COVID19 PCR) post vaccination on 23Jan2021: Negative. Outcome of event headache was recovered on 16Jan2021 and all the events was recovered on an unspecified date. Information about lot/batch number was requested; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded, considering the temporal relationship. However, it is worth noting that the 68-year-old female patient had pre-existing osteoarthritis, which could be one of the causes of joint symptoms. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-02-09 headache Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 P... Read more
Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 PMon the 6 Feb. 2021. body aches. On 7th the same. Nausea went away on 8th. arm sore. went away on 9th. the nasty taste still have it on 10th. No headche stopped on 9th. Just feel week. going away on 9th of Feb.
68 2021-02-09 headache Pin prickly feeling in different areas of her body; Headache; Funny feeling on the top of her head a... Read more
Pin prickly feeling in different areas of her body; Headache; Funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation; Stinging feeling in sinus cavity; This is a spontaneous report from contactable consumer (patient) A 68-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot#292673 on left deltoid (reported as left shoulder) on 25Jan2021 11:21 at SINGLE DOSE for covid-19 immunisation . Medical history included diabetes from 11Sep2001 and ongoing , ongoing cardiac pacemaker insertion Put in about 7 years ago , ongoing blood cholesterol increased Diagnosed about 24 years ago , ongoing blood triglycerides increased. She is allergic to statins. Concomitant medication included alirocumab (PRALUENT) 1 mL at 1ml injection every 14 days for High cholesterol (Injection on side or top of her leg. She has been taking for about 4 year).The patient experienced headache on 25Jan2021 with outcome of recovered , funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation on 25Jan2021 with outcome of unknown , stinging feeling in sinus cavity on 25Jan2021 with outcome of recovered , pin prickly feeling in different areas of her body on an unspecified date with outcome of unknown. Clincial course reported as follows:She got the first dose of the vaccine today and while she was sitting in the observation area, she started getting a headache. It was close to noon and she just blew the headache off since she was a diabetic. She started getting a funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation. When the feeling hit her sinus cavity, it was like a stinging. She started drinking water and she had lunch. Within an hour it started getting better and within 3 hours it was a lot better. She has a pin prickly feeling in different areas of her body but did not have the numbness sensation. She tried to report this online. She only had one virtual visit with her doctor. Treatment: declines any, she was drinking plenty of water to try and flush some it out of her system.
68 2021-02-09 fever, headache woke up with burning in her ears; fever; Low grade headache/worse headache; This is a spontaneous re... Read more
woke up with burning in her ears; fever; Low grade headache/worse headache; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), on Jan2021 07:30 PM at single dose in Right arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Systemic Lupus Erythematosus. Concomitant medication received within 2 weeks of vaccination included denosumab (PROLIA), trazodone, ezetimibe, simvastatin (VYTORIN), duloxetine, hydroxychloroquine sulfate (PLAQUENIL), cevimeline. Low grade headache occurred the day after the vaccine on 22Jan2021 04:30 AM and has lasted until now. But 24Jan2021 the patient woke up with burning in her ears, a worse headache, and a fever. The outcome was Recovering. No treatment received for the adverse event. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. All the events were assessed non-serious. Information on the lot/batch number has been requested.
68 2021-02-10 pneumonia, fatigue, respiratory tract congestion, malaise arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; f... Read more
arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; fatigue; Muscle aches and pains; she became ill; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 06Jan2021 at single dose on right deltoid for covid-19 immunisation. Medical history included blood pressure high and seasonal allergies. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 16Dec2020 for COVID-19 immunization. The patient experienced community acquired pneumonia, shortness of breath, chest congestion, weakness, fatigue, COPD, muscle aches and pains, she became ill, all on12Jan2021; arm soreness on an unspecified date. Events required Emergency Room visit. Clinical course reported as: she got the second dose of the pfizer covid vaccine on 06Jan2021 and on 12Jan2021 she experienced shortness of breath, chest congestion, weakness and fatigue. Nurse stated ER doctor thought she had COPD or community acquired pneumonia. Nurse further stated she had the second COVID-19 vaccine on 06Jan2021. A week later on 12Jan2021, she became ill. She had all the symptoms of COVID. She was short of breath, very fatigued. She couldn't get any air, she was at work. She had muscle aches and pains. The shortness of breath, fatigue and weakness lasted several days. She also had severe chest congestion. She confirmed she got better. It actually took 4 or 5 days. By that Sunday (17Jan2021) she was better. She wanted it noted she had no reaction right after the shot. She stated she only had arm soreness, it was just a little sore, not even worth mentioning. It was only when she moved her arm a certain way. This was with either vaccine (first or second vaccine). She went to the doctor and somebody thought it might be a reaction, but the nurse thought it was too late for a reaction. The ER doctor thought it was COPD and community acquired pneumonia. Her primary doctor thought it was COPD. The patient underwent lab tests and procedures which included COVID-19 test: negative on 12Jan2021. Outcome of arm soreness was unknown, others was recovering.; Sender's Comments: Based on the drug-event time interval and the vaccine's safety profile, the community acquired pneumonia is possibly intercurrent condition, unrelated to vaccine BNT162B2 administration, which is not the disease that the vaccine BNT162B2 can prevent from. While the COPD is more likely underlying condition, unrelated to vaccine BNT162 injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-02-16 runny nose, sleepiness out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck ... Read more
out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck was numb/Numbness in leg/jaws are numb; I'm feeling my teeth are still and my jaws are numb; felt very odd sensation as she was swallowing; was closing up but much wasn't closing up/it was not full open; swelling on her throat; Muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side; it hurts my neck area across my back; it hurts my neck area across my back; Stumbling; face was swollen; eyes looks like little switch; thirsty; felt very sluggish; nose started to running; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 29Jan2021 15:00 for COVID-19 immunization. Medical history included insomnia and asthma. The patient's concomitant medications were not reported. Patient stated, "I got the vaccine yesterday about 3 pm and I came home and I had dinner and sat down to watch TV at 9 O' clock, I turn the program on and I was out like a 'light' and this stuff knock me out (onset date: 29Jan2021). My dog has to wake me up licking my face at 3:15 this morning. I normally don't sleep long 4 hours and that's it. I'm 68 years old and I have insomnia (History) but when I woke up I was stumbling around, still have to sleep (onset date Jan2021), I took the dog out to walk and came back and saw myself in mirror, my face was swollen and my eyes looks like little switch. I noticed, I was thirsty and I went to get and drank, some coke because I felt very sluggish and I drank some coke and when I was swallowing the coke I felt very odd sensation as I was swallowing, I noticed that after swallowing. I have asthma (History) to begin with so I'm anticipated on having some of the symptoms it start showing up a bit, my nose started to running and I noticed that my whole entire face my head, down my back my neck was numb along with swelling on my throat, I felt okay but I felt it wasn't being, it was closing up but much wasn't closing up you know what I mean it was not full open. I also had muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side. I also noticed I went to a lovely person and when I went to bathroom I pull my pants down I felt numbness on my legs. So, my whole body was kind of having that not tingling sensation but numb and when I ran my fingers across my leg you know how you feel numbness when you run your fingers across a part of your body when it's numb that's exactly how I felt and that was about 3:30 this morning that happened I woke up by but I also want to ask question because I got to go back to my second shot. I'm wondering if I go back to my second dose am I going to have even more intense reaction to the stuff that I get this time." Patient further added "I was still trying to eat something but I'm feeling my teeth are still and my jaws are numb and this I got since yesterday (29Jan2021)." The outcome of events was unknown. Information on the lot/batch number has been requested.
68 2021-02-17 fever, chills This is a spontaneous report from a contactable consumer reported for herself. This 68-year-old fema... Read more
This is a spontaneous report from a contactable consumer reported for herself. This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EL9265), via an unspecified route of administration at single dose in the left arm on 31Jan2021 11:30 for covid-19 immunisation. Medical history included liver disorder, kidney disease, asthma, allergies to PCN, Sulpr, Iodine dye, pineapple, spinach. Concomitant medications were not reported. On 01Feb2021, the patient experienced achy, fever, chills and neck muscle sorenesswith. No treatment required. The outcome of the events was recovered on an unspecified date in Feb2021. The vaccine was administered at Health Clinc and facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient had not been diagnosed with COVID-19 prior the vaccination.
68 2021-02-21 fatigue, headache Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat clo... Read more
Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.
68 2021-02-21 fatigue, fever, chills Got up the next morning after 1st vaccination with crusty eyes, itchy and watering. Self care till ... Read more
Got up the next morning after 1st vaccination with crusty eyes, itchy and watering. Self care till sunday 3rd day went to UC. Said I had pink eye. Gave medication. Later in the day started with fever, fatique, chills by day 5 after vaccination was told to get a Covid test which came back negative. They felt I had a late immune response. Was in good health for 2nd vaccination and the same thing happened with my eyes. Pink eye. We are 20 days out from 2nd vaccination and have pain in eyes, and watery. Spoke with Opthamologist office and they suggested 1st I try Refresh for 2 weeks if my eyes are not better will need to be seen. could be a response from the vaccine.
68 2021-02-21 headache Intense headache from temple across eyes to temple. Severe eye pain. Totally unlike my migraines. La... Read more
Intense headache from temple across eyes to temple. Severe eye pain. Totally unlike my migraines. Lasted two days Also body aches. Lasted two days
68 2021-02-21 headache Pt. in tent 4 at 2:31 at observation lane was reporting throat tightness and headache. Paramedics a... Read more
Pt. in tent 4 at 2:31 at observation lane was reporting throat tightness and headache. Paramedics assessed vitals. Bp 210/115. Paramedics and Pt. wanted her to go to the hospital. Emergency services was called. She was transported.
68 2021-02-21 throat irritation Scratchy throat. given Benadryl and relieved. No respiratory symptoms.
68 2021-02-21 productive cough, chills, body temperature increased, headache That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning... Read more
That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning went to work and then around 9:30 the chills started, checked my temp 99.8 decided to take myself home, at took temp again, 101.7 then an hour later 102.7 where it remained for the rest of 2/18/21. By the next morning no more chills and temp 97.6. I do have a lingering headache on both sides of my head which meanders down my neck. The site of the injection is still sore and seems to have moved 3 inches down my arm. And there is also a lingering phlegm problem building up at the back of my throat.
68 2021-02-21 chills, headache injection site pain, body ache , headache, stiff neck, dizziness, chills, swollen lymph glands in un... Read more
injection site pain, body ache , headache, stiff neck, dizziness, chills, swollen lymph glands in underarm area. acetaminophen 1000mg every 8 hours was effective for pain relief . bed rest
68 2021-02-22 runny nose, cough, headache About four days after the shot I started having a runny nose and a cough with lots of clear mucus ... Read more
About four days after the shot I started having a runny nose and a cough with lots of clear mucus from both. Then it went down to my lungs and my lungs really hurt . I do have asthma so maybe that?s a part of it? It just seems strange that I was coughing so much and gave me a headache. Then about six days later I got an attack of IBS. I haven?t had an attack like that for two years. Maybe it?s all a coincidence? Also about 3-4 days after shot I had a herpes outbreak.
68 2021-02-22 chills Chills & body aches Chills lasted about 8 hours Aches lasted 3 days
68 2021-02-22 sweating Dizziness, weakness, sweating, confusion,stumbling when trying to walk.
68 2021-02-22 chills, fever, fatigue Fever, chills, fatigue, ache, at injection site minor soreness. This went on for about 32 hours
68 2021-02-22 fatigue, chills I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early ... Read more
I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early morning (~2:00am Friday, Feb 19) I had the chills for about 2 hours. I had intermittent muscle pain, nausea, and fatigue. These symptoms resolved during the day Friday, February 19th.
68 2021-02-23 cough, nasal congestion After receiving her vaccine, client stated she started to cough. Client stated she has a stuffy nos... Read more
After receiving her vaccine, client stated she started to cough. Client stated she has a stuffy nose for the past 3 days.
68 2021-02-23 chills, fatigue Body aches, chills, tired, nausea, started next morning, lasted a day and a half.
68 2021-02-24 malaise, headache, fever 2.5 inch redness, swelling, itching, painful with a couple of hive looking spots at injection site ... Read more
2.5 inch redness, swelling, itching, painful with a couple of hive looking spots at injection site Also headache, fever, malaise
68 2021-02-24 headache, fatigue After first shot on 1/28/21: Very slight headache next two mornings and very slight arm at site of s... Read more
After first shot on 1/28/21: Very slight headache next two mornings and very slight arm at site of shot. After second shot on 2/20/21: Almost imperceptible arm soreness day after (when driving and arm touched driver door), slight nausea (extremely unusual for me) on afternoons of 2/21, 2/22 & 2/23 along with moderate afternoon fatigue those days (I napped which is extremely unusual for me). Alka Seltzer didn't help but CupOSoup eliminated the nausea completely.
68 2021-02-24 sweating, fever Body aches joint pain, sweats, fever
68 2021-02-24 sweating, malaise Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10... Read more
Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10 minutes into observation she developed abdominal pain and felt like she needed to have a BM. She sat on the toilet and had an episode of diarrhea and started to feel flushed, diaphoretic and stood up to go to the sink. She then felt nausea, dizziness and lightheaded and placed her head down leaning over the sink. EMT arrived to bathroom and sat patient down in a wheelchair. I arrived on scene shortly thereafter and the patient was pale and diaphoretic stating she did not feel well. EMS was activated. She was placed on the cardiac monitor and her HR was NSR in the 80's. BP 114/61, 96% on RA. Denied CP, SOB, rash, mouth, lip or tongue swelling. She was brought back to the observation area and was assisted to the gurney. Cool compresses were placed on her forehead and behind her neck. Medics arrived to scene to assess the patient. She stated she was feeling improved and did not want to go to the ED. She signed the AMA form. She was given water and crackers. She was monitored for 1 hour and stated she felt improved. She denied dizziness, lightheadedness, nausea or abdominal pain. I assisted her to the bathroom and she had one more episode of diarrhea. She stated she felt improved after that. She was monitored for 15 more minutes and stated she would like to go home. She was able to get up off the gurney without assistance, stated she felt well. She was ambulatory with a Steady gait and assisted outside. Prior to discharge I recommended she follow up with her PCP. Advised that she rest for the remainder of the day and to activate 911 should she develop any new or worsening symptoms. Advised that if she does get the second dose of vaccine she should be laying down at the time of administration and for 30 minutes after the injection for observation.
68 2021-02-24 chills, influenza like illness, headache, malaise Symptoms: chills, joint pain, severe headache with blurry vision, injection site soreness, muscle pa... Read more
Symptoms: chills, joint pain, severe headache with blurry vision, injection site soreness, muscle pain, feeling unwell - very sick, fatigue. I woke up 2/23/2021, Tuesday, with injection site tenderness upper left arm. Tuesday midday the headache began. By evening, I had chills, pronounced joint and muscle soreness, with further progression of headache to severe with vision changes, and a general malaise and feeling very ill. Like having the flu without fever or congestion. I did not seek medical treatment. Symptoms were treated with over the counter medicines and perscriptions medicines on hand, plus bedrest.
68 2021-02-25 fatigue, headache, chills Fatigue, Chills, Headache, sore arm at injection site. Took x2 extra strength Tylenol and took a na... Read more
Fatigue, Chills, Headache, sore arm at injection site. Took x2 extra strength Tylenol and took a nap. All signs and symptoms relieved by next day
68 2021-02-25 cough Patient started with slight cough while waiting 15 minutes. Patient then walked to make next appoint... Read more
Patient started with slight cough while waiting 15 minutes. Patient then walked to make next appointment and started wheezing and having trouble breathing. Patient given Epinephrine 0.3 mg IM and Benadryl 50 mg IM, and sent to ER for further evaluation and treatment.
68 2021-02-25 fever, chills, headache Sore arm, low grade fever, chills, headache
68 2021-02-25 fever, headache, chills, fatigue Tues 2/23/2021: fever no greater than 101, chills, fatigue, body ache, headache all day, very sore a... Read more
Tues 2/23/2021: fever no greater than 101, chills, fatigue, body ache, headache all day, very sore arm. Fever treated with tylenol Wed 2/24/2021: No fever in morning, but headache, body ache, mild fatigue all day, sore arm, then fever of 102 in evening (about 5 pm). Treated with Tylenol successfully, fever abated pretty quickly. Thursday 2/25/2021: No fever or headache, but arm still pretty sore without tylenol. Friday 2/26/2021: feeling fine, arm is very slightly sore.
68 2021-02-25 malaise, chills, headache, fever high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, w... Read more
high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, weakness, overall feeling not well.
68 2021-02-25 headache sustained high blood pressure; Have 2 aneurysms; Continuous headache; some dizziness; This is a spon... Read more
sustained high blood pressure; Have 2 aneurysms; Continuous headache; some dizziness; This is a spontaneous report from a contactable 68-year-old female consumer reported for herself. A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9262), via an unspecified route of administration (right arm) on 26Jan2021, 17:15 at SINGLE DOSE for covid-19 immunisation, at 68 years old. Medical history included allergies: Penicillin from an unspecified date. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is taking unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH 9899, at 68 years old), on 05Jan2021, 16:30, right arm for COVID-19 immunization. The patient experienced sustained high blood pressure, have 2 aneurysms, continuous headache, and some dizziness on 26Jan2021. Therapeutic measures were taken as a result of the events which include 3 different blood pressure medications, still not under control; medications and monitoring of pressure. She mentioned she has 2 aneurysms so she needs to keep her pressure normal. Outcome of the events was not recovered. The event was considered non-serious by the reporter.
68 2021-02-26 headache, sweating, cough 11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:... Read more
11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:30 eggy taste, slight shot ache, 4:30 light headache, 02/13/2021 2:30am woke with a rush feeling of med, started coughing, burst (spread) of warmth in center of chest, slight perspiration; 3:30am heart racing, warmth in chest, modest itchiness(arm, face & torso), soreness at injection site. 02/14/2021 7am burning/ itching injection site, & chest/torso arm red and square blotch about 1 1/2 inch very itchy and burning for several days. 02/23/2021 itchinesss better. Brown square area at site of injection. There is still a slight itch at times as if healing.
68 2021-02-26 fever Anxiety and Pyrexia . Negative all other symptoms. Pt held for observation and provider released
68 2021-02-26 fever Daily fever to 101., which resolves in the afternoon
68 2021-02-26 cough, throat irritation Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itch... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itching. Shortly after, developed a dry cough and reported that her throat "felt funny." Patient began vomiting and having difficulty breathing, speaking in 1-2 word sentences. Pt received epi pen to left thigh, with some resolution of symptoms. Pt continued to have cough and nausea, chest pain. Gave 25 mg benadryl IM at 08:27 am. Patient received 2nd dose of Epi for increased SOB, difficulty breathing, and increasing cough, with some resolution of symptoms. Patient reported increased chest pressure. Began having seizure like activity at 08:30, lasting approx 20 seconds with no post ictal period noted. EMS arrived after 2nd dose of epi. Second "seizure like" activity after EMS arrival, lasting approx 20 seconds. During transport to ambulance, patient had 2 more episodes of seizure like activity with no post ictal phase. ED note states low suspicion for true seizure since patient was awake during episodes of tonic clonic movements, answering questions during, and did not have post ictal state.
68 2021-02-26 chills, headache Severe & debilitating chills, headache, muscle and joint pain 16 hours after injection and lasting a... Read more
Severe & debilitating chills, headache, muscle and joint pain 16 hours after injection and lasting approximately 8 hours before tapering down to moderate pain level approx 30 hours following injection.
68 2021-02-27 fever, fatigue Fever 99.9 and shaking, after that 102.7 fever and tiredness.
68 2021-02-27 fever, headache, chills, fatigue, head discomfort First shot only chills and mild muscle aches gone by the next morning. Second shot aftereffects wer... Read more
First shot only chills and mild muscle aches gone by the next morning. Second shot aftereffects were very different. Received the shot around noon on Tuesday , February 23, 2021. Later in the afternoon experienced muscle aches and chills. My head felt kind of weird. Hard to describe except I once had a morphine shot that made me feel close. I spent the next ~60 hours in bed. Fever, severe joint and muscle pain, migraine like headache, and brain fog is about all I remember. It could have been 2 hours or 60 hours, I don't remember. On Wednesday and Thursday my sedentary heart rate was 101 and 95 according to my Apple watch up from 77 on Tuesday. Couldn?t eat. Food tasted and smelled differently but not in a good way. Woke up this morning,Friday, with a mild headache and very fatigued but mostly back to normal.
68 2021-02-27 malaise, headache In one hour, extremely dry month, tongue and throat. Sharp pain on left side of forehead that would ... Read more
In one hour, extremely dry month, tongue and throat. Sharp pain on left side of forehead that would come and go. Overall, not feeling well. A few hours later (about 4 hours), tingling and numbness (neuropathy) in my lower legs and arms. Some neuropathy on left side of face.
68 2021-02-27 sleepiness, fatigue, fever Next day could not stand up without vomiting, fever 101, progressively worse as day went on to the p... Read more
Next day could not stand up without vomiting, fever 101, progressively worse as day went on to the point I could not lift my head off pillow. Could not eat, even sips of water or coke. Hard to breathe Day 2 fever 100 and slept most of day, still nauseous and dizzy with no appetite. Hard to breathe. Day 3 slept 12 hours and normal is 7 hours. Able to eat clear broth and drink lots of water. Fever 99.9 but went down to just 99. Normal for me is 96 and sometimes 96. Hard to breathe. Day 4 Teeth look off color. Able to eat egg, but no sense of taste. Sleep almost back to normal, but no energy. Sudden movement or bending I get out of breath.
68 2021-02-27 fatigue, chills, lethargy Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom ... Read more
Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom the last 3 days on hands and knees. Lethargic . Tired. Fatigue. 4 days now. And I am getting worse. Heaviness on chest
68 2021-02-27 chills, headache Several hours after injection my arm hurt down to almost the elbow. Not bad. Next day same until a... Read more
Several hours after injection my arm hurt down to almost the elbow. Not bad. Next day same until about 3:30 and I started to get chills, body aches and pains then nausea and headache. Shivering for 4-5 hours under the covers in bed with extra blankets and clothes. Can?t say I?m overly concerned as searching online I?ve seen reports of similar reactions but best to report. Today feeling a bit better, not shivering but still achy but not as bad and still a little nauseous.
68 2021-02-27 chills chills, shakiness, shortness of breath, body aches
68 2021-02-28 headache, chills, fever Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injecti... Read more
Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injection was on Friday and Saturday we woke up with the side effects. Sunday we were much better and Monday better.
68 2021-02-28 chills, fatigue Chills, dizziness, nausea, vomiting, diarrhea, fatigue
68 2021-02-28 fatigue, headache, fever SEVERE Body pain - just like when I had COVID in October (sick 9 days) Fever: 103.2. Broke la... Read more
SEVERE Body pain - just like when I had COVID in October (sick 9 days) Fever: 103.2. Broke last night. When I had COVID it was 103.2 for 3 days Very light head Exhaustion skull pain
68 2021-02-28 headache, fever Started with severe headache Continued with all over body aches Next day woke up with fever Even wh... Read more
Started with severe headache Continued with all over body aches Next day woke up with fever Even when treated with Tylenol, fever got as high as 102. 4 Within 24 hours I was better but very sluggish and still a little light headed
68 2021-02-28 cough, throat irritation, fatigue intense itching/burning in throat within one hour of vaccination causing incessant coughing; lasting... Read more
intense itching/burning in throat within one hour of vaccination causing incessant coughing; lasting 2 days wheezing and shortness of breath beginning 8 hours after vaccination and lasting at least through Monday Mar1. conjunctivitis and light-sensitivity beginning Saturday (24 hours after vaccination) lasting at least through Mar 1 fatigue commensurate with what others describe as having and worse than many have reported lasting at least through mar 1
68 2021-03-02 chills, fever, headache Fever, headache, body aches, nausea, chills
68 2021-03-02 headache, malaise, fever I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ach... Read more
I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; Unable to eat, loss of appetite.; Not feeling too well; very sick; can hardly move; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9069), via an unspecified route of administration at single dose on 10Feb2021 for covid-19 immunisation. Medical history included diabetes, thyroid removed. Concomitant medication included influenza vaccine, metformin, levothyroxine, ferrous sulfate, atorvastatin. The patient stated that experienced: I got fever, I got diarrhea. I got body ache, headache, unable to eat, loss of appetite, not feeling too well, very sick, can hardly move , all on an unspecified date in Feb2021 with outcome of unknown. The patient was hospitalized for these events from Feb2021 to an unknown date. The patient underwent lab tests and procedures which included investigation: unknown results in Feb2021.
68 2021-03-02 headache Severe headache, extremely high blood pressure 220/120, low blood sugar, anxiety, insomnia
68 2021-03-02 chills, malaise Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general mala... Read more
Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general malaise, lasting almost 2 days
68 2021-03-02 fever, fatigue she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it... Read more
she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it was going to fall off it hurt so bad; she has ran a temperature and that finally broke but the highest was 102.4; She has been so weak she hasn't been out of bed hardly.; tired; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9265), via an unspecified route of administration from 29Jan2021 14:45 (2:45 PM) at single dose on right arm (as she was left handed) for COVID-19 immunization. Medical history included COVID (recovered) on an unspecified date. There were no concomitant medications. No additional vaccines administered on same date of Pfizer suspect. Patient previously got her flu and shingles shot at the end of "October". Patient took the vaccine last Friday (29Jan2021) at the age of 68 years old (reported as "68 and a half"). She does not know if that makes a "different" but her right arm felt like it was going to fall off it hurt so bad, on a scale of 1-10 it was about a 20. It was really tender she put a heating pad on it, she has been sleeping on the heating pad and it was mild now. It was only about a 3 now and it has come down, but it hurt like the dickens. Also she has ran a temperature and that finally broke but the highest was 102.4. Patient has slept around the clock and she has not been out of bed but like 30 minutes out of the last 24 hours (hrs) just to go the potty or drink something. Patient stated "almost gave up holding it was so long". She has been so weak she has not been out of bed hardly. Patient said that she has eaten since, "lets see Saturday night, Sunday, Monday". Patient has not eaten since Saturday night (30Jan2021) or gotten out of bed. She has not eaten anything. Patient has had COVID and recovered so she did not want to catch that again. She confirmed that she had COVID prior to received the vaccine. She called her primary care and she has a viral phone call tomorrow or visual phone call, whatever its called, she was trying to get over this mess, she feels warm, she was not registering a temperature right now but she had a cold sweat or something right now (01Feb2021). Patient has a call with him tomorrow so he will know about this incase Pfizer calls. Patient stated that she knows with a normal vaccine she might have an ache or something but this one hurt bad, maybe they pushed it in too hard or something she does not know. When asked for vaccination facility type, the patient answered that they had a vaccine clinic they had set up there in a conference room, they had an elaborate set up, go through certain places and there were several steps. Vaccine was not administered at facility (reported as "No hospital"). Patient further reported that her arm on 29Jan2021 (Friday evening) was tender. Patient lives by herself, she came home and does not know if she event ate. All she knows was she was real tired that Friday evening, it was tender and it got worse. Events did not require emergency room and physician room visit, reported as "Not to date but tomorrow she does not know if he will have her come in unless she spikes another fever or if he will do anything she may just ride it out". When asked for adverse events prior vaccinations, the patient answered "no none that she can remember. Sometimes she will have a sore arm that is why she gets it in the right arm because she is left handed thinkin her dominant hand will not have any problems but this one hurt really bad. Have they had many calls where this is really effecting arms really bad?". Patient also reported that her sister had the shot the same day and her arm was a little sore but that was all, she does not have NDC lot expiration for her sisters dose of the vaccine. She went to a different facility in a different location. Outcome of "her right arm felt like it was going to fall off it hurt so bad" was recovering, while for other events was unknown.
68 2021-03-03 fatigue, body temperature increased, headache I received the vaccine at 9AM on March 1st in my right arm. Everything was fine until 3 PM when my ... Read more
I received the vaccine at 9AM on March 1st in my right arm. Everything was fine until 3 PM when my right arm started swelling. I ran a temperature of 100.1, had fatigue and a headache, in addition to aches and pains. By Tuesday morning my right arm from the injection site to the elbow was twice it's normal size. My chest and underarm area were both significantly swollen. I had an 8:30 AM appointment on Tuesday with an allergist who advised me to take Benadryl, which I did. By Wednesday, my chest and abdominal area were both swollen. I had a lymphedema therapy appointment because I have lymphedema on my left side due to node removal. The therapist measured both arms and they were both swollen, including my chest and abdomen. The therapist advised me to see my oncologist as swelling in the Right Arm, (where i received the shot) was normal for COVID shots, but she could not explain the swelling in the chest or abdomen. Other than that my lymphatic system was working overtime. I called my oncologist on Thursday March 4, and they fit me in. Doctor examined me and he couldn't explain to me why I was swelling up the way I was. He has only seen arm swelling in his breast cancer patients. He is referring me to get a PET scan and advised me to see a breast surgeon as maybe the surgeon would know more about the lymph nodes.
68 2021-03-03 malaise, fatigue Malaise, fatigue, red rash over entire abdomen, inner arms, chest and inner thighs
68 2021-03-03 sleepiness Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with... Read more
Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with Pioglitazone 15mg PO on 10/5/2018. Patient called study team stating that she received her second Pfizer COVID-19 vaccination on 02/19/21. Afterwards, she had a sore arm and slept most of the next day. On 02/21/21, she experienced severe right-sided leg weakness and fell while attempting to go to the bathroom. She was unable to ambulate and her son took her to the emergency room. She was hospitalized overnight for a serious adverse reaction to the second Pfizer COVID-19 vaccination. Multiple sclerosis exacerbation was ruled out after extensive testing. Then, she was transferred a Rehab facility on 02/22/21 for physical therapy and occupational therapy. She continues study medication without any missed doses. She will most likely be in Rehab for another week. She was able to walk 80 feet on 2/25/2021 with a walker and gait belt and ambulatory assistance. This is unrelated to study drug. We consider this to be a Non-UP SAE. As of 3/4/2021 the patient is still in rehab.
68 2021-03-03 fatigue, chills chills; very fatigued; sore arm; This is a spontaneous report from a contactable consumer (patient).... Read more
chills; very fatigued; sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration on left arm on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient got her second shot of COVID vaccine yesterday, 01Feb2021, and was asking if she was infectious to anyone. She had some chills, was very fatigued and was a having sore arm. The sore arm started last night (01Feb2021) and when she woke up this morning (02Feb2021), she was with the chills and fatigue. The patient stated that they could be related to the fact that she got up at about 3:00 in the morning. The outcome of the events was not recovered.
68 2021-03-04 cough 30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient w... Read more
30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient was coughing and clearing throat. Fluids were offered and patient was moved to a more private area, vitals were taken. Pulse ox 96% RA, blood pressure was elevated, HR was 86 bpm. Rapid response team was notified and took the patient to the hospital's emergency department.
68 2021-03-04 headache, chills, fever 6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint ... Read more
6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint pain and stiffness., muscle soreness. Noticed voice hoarseness. Attempted to sleep after taking Advil with nightmares and restlessness. Felt this overall feeling of crying and uncontrolled sobbing. I had COVID in May of 2020 with hospitalization, Remdesivir IV. Pneumonia . July I was feeling better with noted Shortness of Breath not brought on by activity. I was able to resume my exercise activity. I walked but no longer able to walk 3-4 miles per day. I am walking 2 miles w strengthening exercise. The headache comes and goes with the addition of Advil and Tylenol alternating takes the edge off. I take a Zyrtec but it does not help
68 2021-03-04 sweating Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseo... Read more
Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseous. Didn't last long. Wiped my face and upper body with washcloth soaked in cool water for relief. Messaged my cardiologist and internist but haven't gotten response yet.
68 2021-03-04 fatigue, fever fever, 100.8, achy, very tired. Took advil felt better within 24 hours.
68 2021-03-04 fever found by husband with AMS on 3/4/21, not responding to questions or following commands. taken to the... Read more
found by husband with AMS on 3/4/21, not responding to questions or following commands. taken to the ER- fever 101.2, HR elevated, decreased BP
68 2021-03-04 headache, chills, fatigue general moderate joint pain, chills, moderate headache, fatigue mostly gone by the morning of 3/5/2... Read more
general moderate joint pain, chills, moderate headache, fatigue mostly gone by the morning of 3/5/2021
68 2021-03-04 fever pt stated that she had a sore arm and low grade fever the night after receiving the 2nd dose of the ... Read more
pt stated that she had a sore arm and low grade fever the night after receiving the 2nd dose of the covid vax. She started having vision problems about an hour after receiving the vaccination. She stated that her vision is blurry and she has to blink a lot so she can see anything. Today 3/5/2021 the only symptom she is having blurred vision. Pt will contact her PCP if her symptoms persist.
68 2021-03-04 headache week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pres... Read more
week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pressure; felt a weird sensation; Tingling in her head and her face; pain in the head and got increasing worse/scalp felt on fire/light headache; scalp felt on fire; she felt a little soreness in arm/12 hours my arm hurt; This is a spontaneous report from a contactable consumer (patient's cousin). A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/Lot number: EL9262), via an unspecified route of administration on the left arm, at age 68 years first dose on 20Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included ongoing anxiety from an unknown date. Ongoing concomitant medication included escitalopram 5 mg for anxiety, calcium and an unspecified multivitamins. The patient had flu vaccine in Oct2020. Patient's cousin called on behalf of cousin and reported that patient was very ill for having severe reaction to the COVID Vaccine. Patient was physically fit and thin received first dose of COVID vaccine on 20Jan2021, 10:30 AM. After her 1st dose, she felt a little soreness in arm, 12 hours her arm hurt and light headache the same day. Patient went to bed a little earlier than normal and slept a little longer since she was 69 years, its her body and it needed more sleep and woke up at noon and her arm was fine and very grateful to have the shot. Two nights later, on 22Jan2021, patient woke up in the middle of the night with tingling and pain in the head and got increasing worse, her scalp also felt on fire and had tingling sensation in her face for 3 weeks. Then, a week after the 1st dose on 27Jan2021, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation on an unspecified date and as she noticed some spikes in her blood pressure, her MD told her to take another 2.5 mg amlodipine if needed (once or twice a day as needed). She confirmed she had no heart rate problems but she actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. The outcome of the event 'eek after the 1st dose, her blood pressure went up to 210/101/noticed some spikes in her blood pressure' and 'tingling in her head and her face' was not recovered, for event 'she felt a little soreness in arm/12 hours my arm hurt' was recovered on 21Jan2021, while for the other events, it was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187054 same patient/drug, different event
68 2021-03-07 fatigue, headache Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to proces... Read more
Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to process thoughts logically. Arm somewhat sore, but not horrible. This lasted until I went to bed Friday night at 11:00 PM
68 2021-03-09 fatigue, runny nose, fever Fever, fatigue, runny nose the day after the 1st dose. . Pt deceased from COVID less than one month ... Read more
Fever, fatigue, runny nose the day after the 1st dose. . Pt deceased from COVID less than one month after 1st dose of vaccine
68 2021-03-09 fatigue Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of p... Read more
Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of pain in toes and tiredness; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318) via an unspecified route of administration on 02Feb2021 at 16:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included pancreatic cancer. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included levothyroxine; pancreatin (CREON); famotidine; latanaprost; and calcium carbonate, vitamin b12, vitamin D (CALCE) from unknown dates for unspecified indications. The patient did not have any known allergies. On 03Feb2021 at 18:00 around dinner time, the patient started with gastrointestinal issues and also had occasional "zaps" of pain in toes and tiredness. These lasted into Saturday night (06Feb2021). The patient did not receive any treatment for the events. The outcome of gastrointestinal issues, zaps of pain in toes, and tiredness was recovering. It was also reported that the patient had not been tested for COVID-19 after the vaccination. No follow-up attempts are needed. No further information is expected.
68 2021-03-10 fatigue, chills She still has fatigue; The extreme pain, mental fog, and disconnect that came with it has all subsid... Read more
She still has fatigue; The extreme pain, mental fog, and disconnect that came with it has all subsided; The extreme pain, mental fog, and disconnect that came with it has all subsided; Cytokine storm; extreme chills with teeth chattering; This is a spontaneous report from contactable consumer. A 68-year-old female patient the second dose of BNT162B2 (Batch/lot number: EN5318) on 04Feb2021 at 1:00 on Left arm for covid-19 immunization. Medical history was ongoing Arachnoiditis (this is a spinal cord disease). Concomitant drugs were not reported. Historical Vaccine was 1st dose of BNT162B2 (Lot Number: EL1283) on 15Jan2021 administered in left arm for covid-19 immunization. She was calling to report a severe reaction that occurred after the second injection. On 05Feb2021 she started to have extreme chills with teeth chattering at 3 AM. She knew this could be part of the symptoms. At 6 AM on 05Feb2021 she got up and with her husband's assessment who is also is a doctor it was determined by her husband she was in a cytokine storm that attacked her spinal cord disease. The extreme chills ended within a couple of hours on 05Feb2021. The cytokine storm has pretty much resolved. It is still there, but better. She still has fatigue. However, the extreme pain, mental fog, and disconnect that came with it has all subsided. Caller stated she knows from research and talking to other people most people might have the chills after the COVID Vaccine. The chills is not the severe side effect she is referencing as severe. The Cytokine storm reaction for her wit her spinal cord disease is unexpected and not normal. This was the severe event. No Emergency Room visited. Physician's Office visited for Cytokine Storm. She should have gone to the hospital, but she did not want to go. Seven days after event started, she went to her physician. This was as soon as she was able to get up and get out of the house. Treatment was mainly self-treating. Her husband is a doctor and they did what they needed to do at home. These side effects were pretty horrific. Outcome of the event cytokine storm was recovering, for fatigue was not recovered, for other events was recovered. No follow-up attempts are possible. No further information expected.
68 2021-03-10 dehydration, headache Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergen... Read more
Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergency room. Admitted to hospital for hospital for 1 day. Was given anti-vomiting/dizziness drugs, CT scan, IV for dehydration, pain and anxiety medicine. Diagnosis was vertigo. Upon release from hospital, consult with internist further diagnosed condition as labarynthitis. Headache and slight dizziness continued for a couple of weeks . After second dose dizziness, light-headedness and headache are significant enough to take Tylenol regularly. These effects are still in place 12 days after 2nd dose. Will see internist if symptoms continue after 2 weeks.
68 2021-03-11 pneumonia, chills, fever Patient hospitalized on 3/9/21 with one week history of fever, chills, and shortness of breath. Tes... Read more
Patient hospitalized on 3/9/21 with one week history of fever, chills, and shortness of breath. Tested positive for COVID-19. Respiratory status worsened on 3/11 requiring transfer to ICU and intubation. Currently intubated in ICU.
68 2021-03-15 head discomfort, headache Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on m... Read more
Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Arm was sore; Had light headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken daily. The patient experienced light headedness and pressure in her chest that went to her left shoulder and jaw. Patient had light headache, pain in chest, and pain in jaw. She woke up this morning feeling better but still had slight pain in jaw. Wondering if side effects are from vaccine and will she be ok. Patient stated, "I have the first dose of the vaccine on 22Jan2021, I didn't have any side effect, my arm was sore but nothing big. But yesterday I feel light headed, like pressure in my chest, kind of pressure on my jaw and shoulder, my left shoulder, and my vitals were okay like my blood pressure, my heart rate and everything was normal. Further she explained this morning I felt better I didn't have pressure on my chest or anything but the pressure on my jaw that go up to my head. Is that related to the vaccine or is something that I have to worry about?" Consumer stated, "The second one is going to be on 12Feb2021, this Friday." Patient stated, "No, I was calling because today I feel better, I don't have the pressure on my chest. But I still have the pressure on my jaw and on my kind of my head. But no I have not called anybody. It's not like an emergency, I am calling because I was not sure about this is related to the vaccine." For treatment consumer stated, "No, today I took some Tylenol, that's all." No investigation assessment. The outcome of the event 'Light-headed' was recovering, the patient recovered from the event 'Pressure in my chest' on an unspecified date, was not recovered form Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head and was unknown for other events. No follow-up attempts needed. No further information expected.
68 2021-03-16 fatigue she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; bu... Read more
she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; burning and itching with bleeding; swelling in lips; Blood in stool/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Blood leaking around rectum/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Face and Neck Burning/hot face and neck was flushed; hot face and neck was flushed; Tingling in tongue, lips, face; Tingling in tongue, lips, face; throat felt tight; lips were puffy; thought she was starting to shake; anaphylactic event; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration in left arm (left shoulder area) on 06Mar2021 17:45 at SINGLE DOSE for COVID-19 immunisation. The patient had no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccination within 4 weeks. Medical history included upset stomach after eating banana's last year (2020). There were no concomitant medications. The patient had no family medical history relevant to events. The patient previously took bactrim and pneumonia vaccine and experienced anaphylactic reaction to both. On 06Mar2021, the patient experienced anaphylactic event, allergic reaction, face and neck burning, hot face and neck was flushed, tingling in tongue, lips, face, swelling lips, throat felt tight, and lips were puffy. On 07Mar2021, the patient experienced rash, blood in stool, blood leaking around rectum, burning and itching with bleeding. The patient further reported that she had a 'serious life threatening event' after first dose of the Pfizer Covid 19 vaccine on 06Mar2021. Hospital papers say 'anaphylactic event.' Tingling in lips tongue and face, hot face and neck after vaccine, swelling in lips, rash started yesterday evening (07Mar2021), bloody stools for a few hours yesterday evening (07Mar2021) but has resolved. The patient was seen in emergency room (ER) via ambulance. The patient asked if there was a chance the preservative in the vaccine caused her reaction and if the potassium in the vaccine causing her anaphylactic reaction. Additionally, the patient reported that she had a severe allergic reaction this past Saturday to the Covid Vaccine, stated the nurse sent her back to the pharmacist who told her she was having an allergic reaction to the vaccine. The patient reported having a hot face and neck was flushed, after the vaccine, she stated she had tingling in her tongue, lips, and face. And she stated her throat felt tight also, her lips were puffy, and a lot of heat of neck and face, thought she was starting to shake. The patient reported the pharmacist gave EpiPen in thigh and 20 mg tablet of Benadryl and called 911, and took her to the local hospital. Patient also reported that she has not seen this doctor yet she asked to see her and has an appointment with her. The patient also stated that her new PCP was not aware of the reaction to the vaccine at this time. The patient further mentioned that she was still having a rash that broke out. She reported that her tongue was tingling and she still has some swelling in her lips. Patient continues to clarify she still has swelling and some tingling on the tip of tongue and half back on her tongue. She stated that the swelling was persisting and that Benadryl or Prednisone does give some relief but it comes back. Patient mentioned being on a 4 day cycle of Prednisone, takes two in the morning with food. The patient clarified the location of the rash as a rash on both arms that was inside of both of the arms, like a pink rash, she states it was on face and on knees around the front and back of her knees like a red rash. She continues it was on the neck down to the collar bone around the back of her neck, like if she was a bust statue it would be all in that area from the collar bones at that point up and around the back of the shoulder blades. It goes all the way around face and neck. Patient also further reported that she had a scary reaction last night (07Mar2021), she said she had blood in her stool, leaking blood around rectum and it had like a burning itch, when she wiped it was blood, she continued to say when she wiped it was like 'giblets.' She stated was stool, blood, and giblets. Patient stated this lasted for about and hour and half or 2 hours until the stool stopped and it was about 1:30 am before she finally went to sleep, she was so tired on an unspecified date. She stated she took Benadryl right away. She continued to report the bleeding has resolved completely as of this point and reported a regular bowel movement today (08Mar2021). She has two Epi Pens from the drug store that was prescribed but she was afraid to use it, and she thought to see what happens if she uses the Benadryl. She received the Epi shot at the drug store, at (pharmacy), when her reaction broke out, on 06Mar2021, in her thigh, for the allergic reaction. This was her first time ever receiving EpiPen (Lot 029F20AA, expiration Mar2022, and NDC is 0093-5986-27). The ER doctor prescribed her 0.3 mg every 5-15 minutes as needed for anaphylaxis, and not to exceed 3 doses. She received the Benadryl at the drug store, 120mg tablet, first dose was given at drug store. Patient reported she was given prednisone IV in hand through IV at ER, she doesn't know how much that was, then was given Prednisone to go home with- 20mg tablets take 2 a day for 4 days, which she started Sunday morning, 07Mar2021. She was told she experienced a life threatening allergic reaction. Patient was taken to the ER in the ambulance, the paramedic who was with her said she was his first COVID reaction patient. ER doctor told her not to take the second dose of Pfizer vaccine, and to be cautious if taking the EpiPen, she states her heart was racing because of the EpiPen and was told it was because she was not younger that her body did not handle the Epi like younger people do and was told she could have a heart attack from the EpiPen. She was scared because she was not covered fully, since she can't get the second shot of Pfizer, and she was afraid of the Epi Pen, so she was really in a tough spot. ER doctor stated she may be able to take the Johnson and Johnson vaccine, as the second, but she needs to talk to her Primary care about that. The ER doctor continued to tell her it would have to be a special case where she was in a hospital setting in case she has another serious reaction, she was concerned for not receiving the second dose because that means she was not completely covered with one vaccine. She was afraid of the Epi-Pen since she can get a heart attack from it because of her age. The patient mentioned she was tested in Oct (clarified as 14Oct2020) for Covid due to having a viral infection at that time but was negative. Added the ER paper work says ED anaphylaxis. The patient wanted to ask about finding out the ingredients in Pfizer vaccine and the ingredients in the Johnson and Johnson vaccine. She saw the list on the fact sheet of Pfizer's ingredients and in a few places it says Potassium, 3 different ingredients, and several months ago, she quit eating bananas, bananas have potassium, and they were giving her stomach upset, diarrhea, she used to eat them all her life, she noticed that there was a lot of potassium in the medicine. Doctor wanted to know if she would be able to take the Johnson and Johnson vaccine. He said if she got the second shot, of the Johnson and Johnson, that it would have to be a special case, like in a hospital setting, and there would have to be medical people in a medical center, to take care of her was she has a reaction to it as well. He advised that she take the Johnson and Johnson than not taking it, because by not taking it, she was very vulnerable to catching COVID 19. And patient wanted to know was it a preservative that was causing the reaction. It was reported that rash began around 10PM, bloody stool began between 11 PM and 12:30 AM, all other symptoms within 15-20 minutes, it began around 6PM, maybe sooner 5:55 PM, she was in denial, it felt like tongue and lips tingling, she did have a reaction before to a different shot. The anaphylactic reaction required emergency room visit. Patient was not hospitalized and was in observation in ER. On 08Mar2021, the patient recovered from blood in stool, rectal bleeding, and burning and itching with bleeding. The patient had not yet recovered from severe allergic reaction, hot face and neck was flushed, tingling in tongue, lips, face; lips were puffy, and rash. The outcome of throat felt tight, thought she was starting to shake, she was so tired, and swelling in lips was unknown.
68 2021-03-17 throat pain, headache a significant headache this morning with pain focused at the front of her head; Weak feeling; feelin... Read more
a significant headache this morning with pain focused at the front of her head; Weak feeling; feelings of weakness in her legs when walking; sore throat; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) solution for injection, intramuscular on left deltoid on 26Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication was reported as none. The patient received the first dose of COVID vaccine on 26Jan2021 and reported a significant headache this morning with pain focused at the front of her head after she was up for a while, she also had a weak feeling, feelings of weakness in her legs when walking and a sore throat, all on 02Feb2021. Her headache was very bad, but after treating with 2 tablets of extra strength paracetamol (TYLENOL) 500 mg, her headache was not as bad as it was. This happened suddenly. Her sore throat started the same time as the headache which was currently gone. She wanted to know if these events could be from the vaccine, a week later; if she should get a COVID test; and how long will the headache last if it came back. The outcome of the headache was recovering and recovered on 02Feb2021 for all other events.
68 2021-03-18 chills, fatigue, fever Fever (101); aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patie... Read more
Fever (101); aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9269) via an unspecified route of administration on 15Feb2021 at 11:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included diabetes and osteoporosis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient had not been diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not have allergies to any medications, food, or other products. The patient previously received dose 1 of BNT162B2 (lot EL9261) on 25Jan2021 at 15:00 as a single dose in the left arm for COVID-19 immunization. On 15Feb2021 at 19:00 after the second dose of BNT162B2 the patient experienced fever of 101, aches, chills, and fatigue all night and into the morning. The events were reported as non-serious. The patient was not hospitalized for the events. The outcomes of fever of 101, aches, chills, and fatigue all night and into the morning were recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
68 2021-03-18 fatigue She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vacci... Read more
She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vaccine, got up from that and had dry heaves, lost her speech and had loose stools. The aide caught her as she was fainting as she would have fallen on the floor. She said it was weird, she looked at people and it looked like they were 2 dimensional and knew something was wrong, but couldn't figure out what as they attended to her. They asked her questions, but she was not able to speak to them. They apparently spent 2 hours with her, but she doesn't believe it was that long, and then they knew she wanted to go to one Hospital and not the other. She had been loosing words before this happened, but not as bad as this one. This was about the same reaction that she had when she got the COVID virus in January. She was then taken to the hospital where she was given fluids and hydrated her and checked her heart, saw a cardiologist and a neurologist to see if those things caused the fainting and had blood work done. They also did a CAT Scan of her head and neck. They told her that she was fine and was discharged back home after 5 days, which was 3/11/21. Since then she has been very tired, she does have GERD and her stomach has been hurting a lot as well.
68 2021-03-20 chills cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up... Read more
cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up; stayed in the bathroom, you know I was just dribbling sometimes; This is a spontaneous report from a contactable consumer for herself. A 68-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269, Expiration date: Unknown) on 08Feb2021 via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history included cholesterol and thyroid from an unknown date and unknown if ongoing. The patient's concomitant medications included vitamins. The patient stated she took medications for her thyroid and cholesterol, and vitamins. On 08Feb2021 at 19:30 the patient had cramping "real bad." The patient was sick all night, had chills, stayed in the bathroom, "you know I was just dribbling sometimes and hurting." The patient could not keep the Tylenol down, it came back up. There was no investigational assessment. The reporter stated she had her first dose of vaccine "yesterday" about 11. The patient was told that the second dose would probably make her sick, but "last night" at about 7:30 she started cramping "real bad," was sick all night, had chills, and just "now" really feeling quite normal. The patient asked if "this in anyway could have affected her kidneys." The patient stayed in the bathroom and "was just dribbling sometimes, was getting normal then she just dribbling and tried Tylenol (taken as treatment) but could not keep the Tylenol." The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
68 2021-03-27 malaise symptoms of liver failure. Liver seems to be shutting down.; began to feel ill, illness continued ov... Read more
symptoms of liver failure. Liver seems to be shutting down.; began to feel ill, illness continued over time; Jaundice; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 68-years-old via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on an unspecified date for covid-19 immunisation. It was reported that within 24hrs of receiving the vaccine on 20Feb2021, the patient began to feel ill, illness continued over time, eventually when to doctor and presented symptoms of liver failure. Liver seems to be shutting down. Jaundice has set in over the past 5 days. It was unknown if the patient received any treatment for the events. The patient did not recover from the events. Information on the lot/batch number has been requested.
68 2021-03-28 chills, cough, throat pain, fever body ache from head to toe; chills; sore throat worsening; sore throat worsening; fever of 101.8F; d... Read more
body ache from head to toe; chills; sore throat worsening; sore throat worsening; fever of 101.8F; dry cough; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number reported as "G or E N6202"), intramuscular in left arm on 27Feb2021 (age at vaccination 68-year-old) at 11.30 at single dose for COVID-19 immunization. She is due to take the second dose of the vaccine on 20Mar2021. Medical history included: she has history of AFIB but has been in regular rhythm and has not taken any medications since 3-4 years ago. Her blood pressure is so low and she was falling all the time, was dizzy and bumping into wall. The doctor said it was a good thing she is off. Her blood pressure is still 90's/60/s. She got shingles two shots and she got it last fall. Those were pretty awful. She had a lot of local tenderness, trouble lifting arm up and the next two days, she felt blah and had pain in clavicle and scapula on left side. That pain in the bone lasted about a week afterwards; diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, she has had low white cell all of her adult life (she has gone between 3.5 and 4.0). Family medical history: Cardiac history. Concomitant medication included: eye vitamins and that kind of stuff. She did not take Tylenol or aspirin two days prior. On 09Mar2021, 11 days after getting the first dose of the vaccine, she had symptoms namely sore throat, chills, body ache from head to toe, dry cough, fever and weakness. She said that it lasted for 36 hours. She felt so crappy on 09Mar she did not take her temperature. She did not take it until 10Mar2021 when it reached a maximum of 101.8 degrees. Patient said she now feels pretty good except she has no energy at times. She wondered if she had COVID, so she got a test on 10Mar2021 and it was negative. Patient reported that she actually had a sore throat for about a year. That may not have been started with the vaccine, but it may have been exacerbated. She thinks she may have Reflux. She made an appointment with her gastroenterologist. She said her throat was red when she went to Urgent care to get the COVID test. She has had a dry cough for about a year. That could be related as well to the reflux. That did not seem to increase since the vaccine. Reporter considered events fever, chills and ached from head to toe as medically significant. Outcome of events sore throat worsening, asthenia was not recovered, chills, ached from head to toe, fever was recovering, of event cough was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Fever, Ache, and Chills cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-03-29 body temperature increased, influenza like illness Within 60 seconds, my heart stated racing, my throat swelled and my tongue grew in size and became l... Read more
Within 60 seconds, my heart stated racing, my throat swelled and my tongue grew in size and became like sandpaper. I had a cold drink with me that I guzzled quickly and forced fluids, taking benadryl. I spiked a temperature to 99.5F within the hour. After that resolved I had 48 hours (still going) of flu like symptoms with temps up to 101.
68 2021-03-29 fatigue pt states that immediately after taking the vax she got light headed and her limbs felt very very he... Read more
pt states that immediately after taking the vax she got light headed and her limbs felt very very heavy. Her BP was up to 192/90. They had her sit to monitor her BP and she became nauseas. She went to the ER. They continued to monitor her BP and she was given IV Benadryl. The heaviness in her limbs lasted many hours. Once her dizziness, heaviness in limbs, and her BP was 141/67 and still coming down she went home. Walking to her vehicle she had the dizziness, heaviness and was light headed again. When she got home she went to bed. Pt woke up having heart palpations. No chest pain or SOB. These palpitations lasted about 15 minutes. On 3/30/2021 she has some fatigue and a tightness around the top of her head. Pt has a FU appt w/ PCP on 3/31/2021.
68 2021-03-30 fatigue MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms... Read more
MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms left eye/decrease color discernment; poor vision left eye/vision from 20/30 to 20/60 corrected in left eye/decreased vision; This is a spontaneous report from a contactable physician. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198) intramuscularly administered in the right arm on 02Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included addison's disease, hypertension and optic neuritis from Aug2020 to Aug2020. Patient was not pregnant. Concomitant medications included hydrocortisone (HYDROCORTISONE), metoprolol (METOPROLOL), fludrocortisone (FLUDROCORTISONE), amlodipine (AMLODIPINE), estradiol (ESTRADIOL) and olmesartan (OLMESARTAN). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) intramuscularly administered in the right arm on 09Feb2021 02:00 PM as single dose for COVID-19 immunisation. On 03Mar2021 07:00, patient had multiple sclerosis (MS), optic neuritis, sore arm, overslept and fatigue. It was also reported that when the patient woke up on 03Mar2021 07:00, she had poor vision in the left eye and experienced color fading; further reported as washed out symptoms in the left eye. She went to the ophthalmologist and saw that she had decreased vision, further reported as from 20/30 to 20/60 corrected in left eye and decrease color discernment. Patient was treated with Methylprednisolone 250mg intravenous (IV) every 6 hours x 12 doses for the events multiple sclerosis (MS) and optic neuritis. The events resulted in physician office visit. The patient underwent lab tests and procedures which included CT angiogram: negative for arteritis on an unspecified date, fundoscopy: normal on an unspecified date, intraocular pressure (IOP): normal on an unspecified date, lumbar puncture: increased protein 79 ms panel pending on an unspecified date. Outcome of events was recovering.; Sender's Comments: The events most likely intercurrent conditions and unlikely related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198). This case will be reassessed when follow-up information is received.
68 2021-04-06 malaise, chills, fever Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vo... Read more
Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vomitting fever severe trembling and chills. During the night nightmares and migraine woke me up. Tried to go to the bathroom but collapsed and knocked my head on the wall. Could not get up crawled to the bathroom and tried to pull myself up but fell headfirst and hit my nose and cheek on the toilet. Cut nose and hurt cheek bone. Felt terrible head spinning and unable to get up/ Crawled to bed; Live alone. Could not even find the telephone; Woke up and tried to get up. Freezing cold. Finally called Ambulance Their doctor refused to send an ambulance and said " go to your GP its not an emergency". I was disgusted barely could walk but somehow drove to the GP. he was closed so went to emergency. the Dr in charge of the vaccination center was there but did not accept it was the vaccine; Finally on the verge of collapse another lady took me to the entrance of emergency. I was finally seen:; Same thing. Dr there told me its not an emergency and to go and see my GP. I was so sick and told him th eGP was not there; His reply " There are plenty of others to see" It was the nurse who persisted and even thought may be I had covid and did the PCR test. I started uncontrollably shivering and was freezing. I had a fever. they did blood tests lung x ray and finally a urine test, Full of blood leucocytes and protein. The same wonderful nurse said its bad. I was by then vomitting again and thought I would die; Uncontrollable shivering ; taken to the lab or a pelvic cat scan;Couldnt even get to sip water. SEVEN hours later the same DR who told me I was not an emergency came in and said " You will have to be hospitalised as you have a serious kidney infection. Acute pyelonephritis. I vomitted on him! Taken to a ward 25 March until 29 March. Rocephin antibiotics. Allergy to that too with migraines and skin rash; They changed the antibiotics. After five horrible days I finally went home on antibiotics Ofloxacine
68 2021-04-06 fatigue pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a s... Read more
pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 11:20 (at the age of 68-years) as single dose for COVID-19 immunization. Medical history included multiple allergies. There were no concomitant medications reported. Her cousin had a similar reaction to flu vaccine. On 20Mar2021, The patient experienced pulse went up, blood pressure was elevated, very tired and fatigue on 20Mar2021.On 22march, the experienced itchy all over her body. The patient was hospitalized for pulse went up from 20Mar2021 to 21Mar2021. The other events (blood pressure elevated, tired/fatigue, itchy) were reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: it was 132/86 on 20Mar2021. At 18:15 pm elevated to 146/91, heart rate: pulse went up to 125 and stayed up for many hours on 20Mar2021 pulse of 118, at 18:15 pm pulse of 153. Therapeutic measures were taken as a result of pulse went up. The outcome of increased heart rate was recovered, elevated blood pressure and pruritus was recovering and fatigue was not recovered Additional information on lot/batch number has been requested.; Sender's Comments: Based on the information currently available and plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events pulse went up, blood pressure was elevated, very tired and fatigue, and itchy all over her body cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
68 2021-04-07 fatigue, fever, cough Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased... Read more
Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased level of care. Patient was admitted to outlying hospital with COVID-19 infection with shortness of breath, cough, fever, weakness, fatigue with decreased oral intake on 3/28/21. Patient required oxygen and was treated with remdesivir, steroids, and antibiotics. Patient was discharged to home with oxygen.
68 2021-04-08 fatigue called back to schedule her second appointment but is was past 42 days so they said she could not sc... Read more
called back to schedule her second appointment but is was past 42 days so they said she could not schedule; tested positive for Covid/Got COVID; tested positive for Covid/Got COVID; Tiredness; achiness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 13:00 (at the age of 68 years) (Batch/Lot Number: EN6200) as a single dose to prevent getting COVID (COVID-19 immunization). Ongoing medical history included high blood pressure (started about 10 years ago) and varicose vein (At least probably about 20 years). Family history includes both of her parents had heart problems, Mother had a stroke (she doesn't know when, she took medications for heart problems) and Father died of a heart attack. Concomitant medications included hydrochlorothiazide taken for hypertension. It was reported that the patient had the first dose on 19Feb2021 and was due to have second dose on 13Mar2021 and two days before that (11Mar2021) she ended up being sick having symptoms (cold) so she had to cancel the appointment and was tested for COVID. On 17Mar2021 the patient found out she got COVID. She called back to schedule her second appointment but is was past 42 days so they said she could not schedule. It was reported that she was not sure when she had COVID-19, it would have been in the evening when she started feeling like she had a cold. She's still having a little bit of tiredness since 11Mar2021 but no cough. Her tiredness is not as bad now. The patient also experienced achiness on an unspecified date in 2021. The patient received the following treatment for the events: Vitamin C, not sure if helped, Vitamin D, not sure if helped, and Advil, helped with achiness. The outcome of the event tiredness was not recovered, while unknown for the rest of the events.
68 2021-04-12 fever 68 y.o. female who presents with FEVER, ALTERED MENTAL STATUS, URINARY INCONTINENCE. DAUGHTER STATE... Read more
68 y.o. female who presents with FEVER, ALTERED MENTAL STATUS, URINARY INCONTINENCE. DAUGHTER STATES INCONITNENCE STARTED Friday 4/9 AND FEVER AND CONFUSION STARTED TODAY WITH SHORTNESS OF BREATH. PT WAS SEEN AND SWABBED FOR COVID AND FLU BUT REFERRED TO ER FOR FURTHER EVAL AND WORKUP. PT IS DIABETIC BUT DAUGHTER REPORTS NOT KNOWING WHERE ACCUCHECKS ARE AS THEY HAVE NO MONITOR AT HOME. Admitted Inpatient 4/13/21
68 2021-04-14 fatigue, throat pain, chills, cough This is the patient's spouse reporting. The day following the vaccination, wife began to suffer mil... Read more
This is the patient's spouse reporting. The day following the vaccination, wife began to suffer mild, common vaccination symptoms such as fatigue, hills, and joint pain. In the days following, in addition to those symptoms, she began to cough and had a sore throat. By March 8th, she had lost her sense of taste and sense of smell. We realized we needed to have her tested for COVID-19. We went to a testing area. She was seen and tested. She tested positive for COVID-19 (as did I). The belief was that our illness was uncomplicated and we were sent home with instructions to monitor our symptoms. On 03/14/2021, I took her to the hospital because her condition was worsening.
68 2021-04-17 malaise 19 second pause of no heartbeat and in third degree heart block; 19 second pause of no heartbeat and... Read more
19 second pause of no heartbeat and in third degree heart block; 19 second pause of no heartbeat and in third degree heart block; Awoke to throw up; Thinks she fainted; Oxygen level of 93 on oximeter; she wasn't feeling well; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Mar2021 at 15:00 (Lot Number: EN6198) as single dose for covid-19 immunization. Medical history included mild stroke from 18Jan2020 and not ongoing, suspected she had atrial fibrillation and she had a heart monitor placed 21Feb2020. Her heart monitor never showed Atrial Fibrillation after one year of being monitored. Ongoing low thyroid/hypothyroidism and blood cholesterol increased from an unknown date. Concomitant medications included levothyroxine taken for low thyroid/hypothyroidism from an unspecified start date (started probably been 10 years) and ongoing; atorvastatin taken for reduce cholesterol from 2020 (started right after she had stroke, either Jan2020 or Feb2020) and ongoing. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 01Mar2021 (at age of 68 years old, Lot Number: EN6200) as single dose for covid-19 immunization. She was fine right after the first dose. She only had a sore arm for 3 days. Just last week, she had a severe adverse reaction right after her vaccine. With the second dose, she had everything possible. Twelve hours after, on 23Mar2021 at 03:00, she awoke to throw up. She thinks she fainted. She had to throw up 2 more times that night. She had been wearing a heart monitor. On 24Mar2021 her cardiologist called her and told her she had a 19 second pause of no heartbeat and was in a 3rd degree heart block. The very next morning, they put in a pacemaker. She was overall healthy and athletic. She was a runner and golfs all the time. She had an outpatient procedure for the pacemaker placement at the hospital on 25Mar2021. She was still recovering but improving. Caller added it was scary when your heart stops. Caller added she did not see this as a possible related side effect, but that evening when she was not feeling well, 22Mar2021, she checked her oxygen level with her oximeter. It was 93 and usually runs around 99. It is back to normal now. She checked it the night she was vomiting. Stated this was before the third degree heart block by a few hours. She did not think it was related. All her symptoms are gone other than the placement of her pacemaker. The outcome of the events " 19 second pause of no heartbeat and in third degree heart block" was recovering. The outcome of the event " Oxygen saturation decreased" was recovered. The outcome of other events was unknown.
68 2021-04-17 fatigue feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head ... Read more
feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head feels tight, like there is a band around it/head feels tight, like there is a band around it; Nausea; severely lightheaded; her limbs felt heavy; her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86; it was hard to lift her arms; This is a spontaneous report received from a contactable two nurses (one nurse reported for herself). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205 and expiration date: 30Jun2021), via an unspecified route of administration right arm on 29Mar2021 at 10:15 as single dose for COVID-19 immunization. Medical history included anaphylaxis (recovering), hypertension ongoing, gastroesophageal reflux disease (GERD), anemia (her hemoglobin dropped to 6.9 and ferritin was low), hiatal hernia surgery (had mesh), a latex allergy (her lips would start swelling) and food allergy (tuna fish). Family history included lung disease (her dad was diagnosed). Concomitant medications included hydrochlorothiazide (HCTZ) 25 mg, daily (been on it for 10 years) taken for high blood pressure from an unspecified start date and ongoing; losartan 100 mg, daily (for about 10 years) taken for hypertension from an unspecified start date and ongoing; iron (Tablet) 65 mg, daily (about 10 years ) taken for anaemia, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication; The patient previously took cefalexin (KEFLEX) and experienced swelling on face and mouth, epipen, acetylsalicylic acid (ASPIRIN) (6 years ago aspirin sensitivity took place) and experienced haematuria, tolectin as nonsteroidal anti-inflammatory drug (NSAIDS) (about 30 years ago (received steroids, breathing treatments and benadryl) and experienced anaphylactic reaction, flu vaccine taken for flu (at 19 years old). The patient got first vaccine on 29Mar2021 and had an event. On the same day, she was severely light headed and her limbs felt heavy and her blood pressure went way up and lasted a good 7 hours. They had her in the emergency room. She did have palpitations overnight that woke her up in her sleep for 15 minutes but she had no chest pain or shortness of breath and then it went away. At first, she didn't feel anything, but then as soon as she got up to go to the sitting area where she was supposed to wait for 15 minutes, she became very very light headed, almost like there was a band around your head. there was no dizziness, but she was lightheaded and all four of her limbs felt really heavy, it was hard for her to move her limbs, she experienced nausea while sitting in the waiting area as well. She did not throw up and it started about an hour after the vaccine and describes the nausea as fleeting and states it lasted about a couple of hours, but not as long as the light headedness and heavy limbs. her blood pressure at this time was elevated to 190/86. the doctor there told them to send her to the ER. The reporter stated that the vaccine was given at the hospital, so they just wheeled her to the emergency department within the hospital, the doctor in the emergency room told her they didn't think it was an allergic reaction. after about 6 hours around 1600 her blood pressure finally came down to 141/67. She was discharged from the emergency room around 16:00 on 29Mar2021. At the time of discharge, the heaviness of limbs and light headedness had went away, but when she was walking to get to her car in the parking lot the lightheadedness and heaviness of her limbs returned. it was hard to lift her arms. she went home and went to bed, the lightheadedness and heaviness of her limbs went away after she was able to lay down and rest. Last night around 2:30 or 3:00am she woke up with heart palpitations. Caller states that these palpitations went away after 15 min and that she hasn't had this experience in years since hiatal hernia surgery. she felt much better next day, the only thing she felt today was tightness in her head but not a headache and just felt tired. The outcome of the events severely lightheaded, her limbs felt heavy, her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86 and head feels tight, like there is a band around it were recovered in 2021; nausea was recovered on 29Mar2021; palpitations was recovered on 30Mar2021 and other events were unknown. As reported causality : Feeling light headed; Limbs felt really heavy; high blood pressure Related; head feels tight, like there is a band around it; heart palpatations Related. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect COVID19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
68 2021-04-17 headache her MS symptoms exploded; head became foggy; blurred eyes; slight headache; This is a spontaneous re... Read more
her MS symptoms exploded; head became foggy; blurred eyes; slight headache; This is a spontaneous report by contactable consumer(patient) from Pfizer Sponsored program. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Mar2021 at single dose for COVID-19 immunization. Medical history included Multiple Sclerosis (MS) for 20 years and autoimmune disease. Concomitant medications included interferon beta-1a (AVONEX) for MS. The patient previously took Avelox for MS. Caller also states she would like to report that she has a history of Multiple Sclerosis (MS) and she goes to the clinic. Caller states since no studies were done on people with MS, she would like to report her experience. Caller states she received her first dose of the vaccine on 17Mar2021 and hours afterwards her MS symptoms exploded. Caller states she has had MS for 20 years and she doesn't even realize she has it because she is able to walk the dogs at the pound and she does 3600 steps a day and it doesn't keep her from doing anything. Caller states after the shot she has torn meniscus in her knees and her knees were so tight and she has heel spurs, and they were burning and hurt. Caller states she hurt her hand previously and her hand was tight, and it felt like it was going to explode. Caller states every injury she has ever had it felt like it was exacerbated and got worse. Caller states she was instructed by the Clinic to take Tylenol every 6 hours and these symptoms lasted for 12 days. Caller states she takes a medication called Avelox for MS once a week and she didn't take it after the shot because it is known to cause flu like symptoms, but she is back taking it now. Caller states she was working on the computer and her head became foggy and this lasted for six or seven days. The caller has MS and is on Avonex, it's a beta 1 interferon injectable that she has been taking for over 20 years. The caller's doctors told her it was okay to get the shot. Because of the caller's autoimmune disease, the caller's doctors don't know how effective the shot will be with an autoimmune disease. The caller has done well with Multiple Sclerosis; her Multiple Sclerosis was really good she was walking 3600 steps a day. The vaccine seems to have flared up everywhere the caller has been hurt. It made those spots worse. The caller had a torn meniscus and it felt like her knee was stiff like a board. The caller had a bone spur in her foot that it began to hurt where that was removed. The caller broke her left hand and then it felt like it was going to explode. The caller also had head fog and blurred eyes. It took 6-7 days for head fog to get better. The other symptoms it was 12-13 days to get better. The caller also had a slight headache. The clinic said there were no studies in someone with MS who took the covid vaccine, they only reported to them about the autoimmune disease. Someone on the thing said the second dose was 10 times worse than the first one. Then the caller was told if she gets those symptoms with the first shot then the second one will be better because your body is used to it and knows what to do. It is kind of like a trial by fire and no one knows what to expect. The caller wants to know if Pfizer had any information on Avonex interfering with MS. The outcome of the events was unknown. Information on the lot/batch number has been requested.
68 2021-04-17 pneumonia second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021.; Second vaccine on 16Mar2021... Read more
second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021.; Second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021; pneumonia; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6200), and dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Batch/Lot Number: EN6202), both as a single dose for covid-19 immunization. The patient's medical history included blood pressure high and diabetes from an unknown date, and brain aneurysm from 2006. Patient has no family history. The patient's concomitant medications were not reported. On 21Mar2121, the patient experienced on the second vaccine on 16Mar2021 patient tested positive for covid on 21Mar2021. It was further reported that the patient took the 2 shots and the last shot was on 16Mar2021. In-between 16Mar2021 and 21Mar2021 the caller developed a cough (given Quercetin to take for it) and went to the urgent care on 21Mar2021. From the urgent care the patient was sent to the hospital and admitted because she was covid positive. Patient was admitted in the hospital from 21Mar2021 to 23Mar2021. The patient underwent lab tests and procedures which included chest x-ray: pneumonia on 21Mar2012 (pneumonia of left lower lobe due to infectious organisms). The outcome of the events was unknown
68 2021-04-20 malaise Received 2nd COVID vaccine on 4/19/21. Apparently hadn't been feeling well since. Presented to the... Read more
Received 2nd COVID vaccine on 4/19/21. Apparently hadn't been feeling well since. Presented to the ED on 4/21/21 with hypotension, bradycardia, hypoxia and a GCS of 3. Does have a history of ESRD on HD, but no missed dialysis sessions. Found to have a potassium of 8.7. There was concern for pulmonary embolism but was not hemodynamically stable enough to undergo imaging. Went into PEA arrest x 3 in the ED and ultimately died. Of note, patient did have a recent ankle fracture recently and apparently has been non-ambulatory for at least the past few days.
68 2021-04-21 nasopharyngitis, runny nose, throat pain Bitter, metal, tinny taste in mouth within one hour or less of vaccination. I am not sure of exact t... Read more
Bitter, metal, tinny taste in mouth within one hour or less of vaccination. I am not sure of exact time because we ate directly after the fifteen minute waiting period. I didn't notice the sensation until right after we ate. It lasted about three days and then was gone. It was strong enough for me to notice immediately and think how weird, and it was strong enough for me to notice it off and on the next three days-gradually lessening. I have also had a sore throat the whole week since the vaccination-it started the day after. It hasn't turned into a cold-maybe a little drippy nose occasionally so not sure if sinuses etc, but the sore throat is persistent. Occasionally I feel it up higher in the nasal-pharynx also. I didn't report to my doctor or treat in any way. And for statistics, my arm was sore for about two days. The worst was that evening and pretty mild after that.
68 2021-04-24 fatigue appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain e... Read more
appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain except it didn't stay in one part of the body.; This is a spontaneous report from a contactable consumer (reported for herself). A 68-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199), administered in right arm via an unknown route of administration on 22Mar2021 at 09:00 am as SINGLE DOSE for covid-19 immunization. The patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6200), administered in right arm via an unknown route of administration on 27Feb2021 at 08:00 am. The patient medical history included blood pressure measurement. Concomitant medications in two weeks included Olanzapine 2.5mg, Olmesartan 20mg and Zetia 10mg. The patient had drug allergies for Codeine and Demerol. On 22Mar2021 within 12 hours, the patient started with nerve pain on the level of shingle pain except it didn't stay in one part of the body. The whole body was affected. Next day on 23Mar2021, the patient was sore and tired. On 26Mar2021 at 3:30 pm, the patient had abdominal pain and went to hospital at 09:00pm because of pain and was diagnosed with an appendicitis. The treatment for the events included appendectomy surgery to remove the next morning. There was no other vaccine in four weeks. On 26Mar2021, the patient was tested for covid with nasal swab post vaccination which was negative.The patient was hospitalized for 2 days for all the events. The outcome of the events was recovering.
68 2021-04-24 fatigue chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any ... Read more
chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any Cardiac history; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; irregular heart rate and am going to have to more cardiac work up; extreme shortness of breath with minimal exertion; weakness; dizziness; very tired; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:15 (at 68 years old, not pregnant), single dose for covid-19 immunisation. Medical history included hypothyroidism, arthritis, all from an unknown date. The patient had her first dose of bnt162b2 for Covid-19 Immunization on Mar2021. The patient was taking unspecified concomitant medicines. The patient experienced within 5 minutes after receiving her second injection, she began having chest pain and palpitations. The paramedics ran a 4 lead EKG and she was experiencing consistent PVC's which is abnormal because she does not have any Cardiac history. She went to the emergency room and was noted to have a D-Dimer lab result of 758ng/ml as well as other abnormal labs. Still continue having PVC's and irregular heart rate and was going to have to more cardiac work up. Also have experienced other symptoms associated with actual COVID such as extreme shortness of breath with minimal exertion, weakness, dizziness, very tired. And muscle aches 2 days as of Friday 09Apr2021. All the events also reported as started 07Apr2021 14:15. The outcome of the events was not recovered. Treatment for the events was observation and medication. Patient was hospitalized due to the events for 1 day. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.
68 2021-04-24 fatigue, headache, chills, fever fever 103.4; Injection site pain; tiredness; headache; chills; joint pain; nausea; This is a spontan... Read more
fever 103.4; Injection site pain; tiredness; headache; chills; joint pain; nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 30Mar2021 at 10:45 (Batch/Lot number was not reported) as a single dose (at the age of 68-years-old) for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing, and high cholesterol from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included pravastatin at 40mg taken for an unspecified indication, start and stop date were not reported; benazepril at 20mg taken for an unspecified indication, start and stop date were not reported; and esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) at 40mg taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever 103.4 on 31Mar2021 at 20:30, injection site pain on 31Mar2021 at 20:30, tiredness on 31Mar2021 at 20:30, headache on 31Mar2021 at 20:30, chills on 31Mar2021 at 20:30, joint pain on 31Mar2021 at 20:30, and nausea on 31Mar2021 at 20:30 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103.4 on 31Mar2021. Treatment was not received for any of the events. The outcome of the events fever 103.4, injection site pain, tiredness, headache, chills, joint pain, and nausea was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
68 2021-04-24 cough, sneezing has pain in the right side of her stomach when sneezing and coughing; has pain in the right side of ... Read more
has pain in the right side of her stomach when sneezing and coughing; has pain in the right side of her stomach when sneezing and coughing; pain in the right side of her stomach when sneezing and coughing, and a very deep pain upon movement; slight dizziness; This is a spontaneous report from a Pfizer-sponsored program. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in deltoid left on 06Apr2021 at 12:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (had coronavirus last year) on an unspecified date in 2020, blood pressure and blood cholesterol abnormal, sleep disorder, prophylaxis for heart disease, hypertension and premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing. Concomitant medications included amlodipine; olmesartan medoxomil taken for hypertension; acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) taken for prophylaxis; atorvastatin calcium taken for blood cholesterol; metoprolol taken for hypertension; melatonin taken for sleep disorder, all from an unspecified start date and ongoing. She has taken medication for blood pressure and cholesterol for years and never had this type of pain. She takes amlodipine, olmesartan medoxomil and was taking Bystolic before and it was working ok but she would have PVC's and that was discontinued, and she was placed on metoprolol. The PVC's are better, better control over the PVC's. Clarified she had the PVC's before the medications. The patient previously received a flu vaccination for influenza immunization and got soreness at the injection site. Reporter stated that on her right side when she presses down in the area, she feels it a lot, has pain in the right side of her stomach when sneezing and coughing, and a very deep pain upon movement. These started mildly several hours after the vaccine on the same day and then progressively got worse over the last 2 days, 07Apr2021 was very bad and 08Apr2021 also and she still has it this morning. It let up a bit this morning. The slight dizziness started the same day as the vaccine a few hours later and has stayed about the same, it may be improving a little she thinks as she didn't really evaluate it this morning, but she thinks it might be a little better. The dizziness she knows you can have light dizziness as a side effect from the vaccine and it is not serious, it can be a normal side effect for people, that most people she has spoken to didn't have dizziness. The pain is a little less today, she is moving around now, and it has lessened to some degree, it is not as severe as yesterday or the day before. She didn't know if her liver was being affected or what, it is in that area. She feels her symptoms are 100% related to the vaccine. Consumer stated, "I took Pfizer COVID vaccine on 06Apr (06Apr2021) and after that I started feeling dizziness and pain in my stomach area or abdomen area and now the third day it is really bad. All I had was the Pfizer COVID Vaccine." When paraphrased the concern, consumer stated, "Yes, It is in my stomach area." The events coughing, sneezing and stomach pain were considered medically significant by the reporter. The outcome of the event slight dizziness was recovering, while of the rest was not recovered.
68 2021-04-26 chills chills, dizziness. shortness of breath developed a few hours later .
68 2021-04-27 influenza like illness, cough, fatigue, headache, fever Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest;... Read more
Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest; nausea feeling in her chest; She gets this laryngitis; has trouble talking; She wants to make sure its not going into like a viral pneumonia; Flu-like symptoms; fever; achy; fatigue; Sore arm; Headache; This is a spontaneous report received from a contactable pharmacist (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: CER230) via an unspecified route of administration on 24Mar2021 at 11:30 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 immunisation. The medical history included flu and suspected COVID-19 both in Jan2020 to an unspecified date (she had a bad flu back in Jan2020, which could have been COVID because it was such a bad flu, over a year ago), ongoing asthma from an unspecified date (mild asthma) and chest nausea in Jan2020 to an unspecified date. The patient had no history of any adverse events following prior vaccinations. Medical history (including any illness at time of vaccination) was also reported as none. Family medical history relevant to the adverse event included an uncle that had asthma, but no one else had breathing issues. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR) and ipratropium bromide/salbutamol sulfate (DUONEB), both ongoing and taken for asthma on unspecified dates. Other products were also reported as "no". The patient did not receive any prior vaccinations within 4 weeks prior to the COVID-19 vaccine and did not receive any additional vaccines on the same date as the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: 3N6202) via an unspecified route of administration on 24Feb2021 at 11:30 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunisation. On 24Mar2021 the patient experienced sore arm and headache; on 25Mar2021 the patient experienced flu-like symptoms, fever, achy, fatigue; on 02Apr2021 the patient experienced asthma flare up, dry, hacky cough, pain and tightness in her chest, nausea feeling in her chest; on unspecified dates in Apr2021 the patient experienced she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia. The reporter classified the events headache and flu-like symptoms as non-serious. The patient called to report that she had an asthma flare up 10 days (as reported) after her second dose of COVID-19 vaccine on 24Mar2021. The patient stated that she did not get a flare up often, she had mild asthma. She usually got mild flare-ups since she did not have severe asthma. She stated it could be something else, but she had not had a flare-up like this since she had a bad flu back in Jan2020, which could have been COVID-19 because it was such a bad flu. That was over a year ago. She received her second vaccine on 24Mar2021, and the asthma flare up and hacking cough started on 02Apr2021. On the night of 24Mar2021, she started with a headache. She had the shot at 11 something and by that evening before she went to bed, she had a headache and a sore arm, but that was no big deal. Then on 25Mar2021, she started with flu like symptoms/fever. The headache persisted through that as well. At that point, she did not have tightness or the dry, hacky cough. By the middle of the day on 27Mar2021, her flu-like symptoms were gone. She would consider these to be "non-serious", it was what she expected, as it was seen from the paperwork of the vaccine. By 28Mar2021, all of her symptoms were gone prior to the flare-up. She had typical flu-like symptoms: fever, headache, achy, fatigue on the 2nd, 3rd, and into the 4th day but then they cleared up. By the evening of the 4th day, she started feeling fairly normal. She stated that they were mild flu symptoms. Her temperature was only 100 for about a day. She stated that that was expected. Then, she went into this flare-up about the 10th day after the vaccine. The first 3 or 4 days after the flare up began, the flare up was worsening. Then, she got it under a little bit of control, so she was not coughing all night and having to sit up as she was sleeping. Now, she was concerned about the pain and tightness in her chest and the hacky cough. She wanted to make sure it was not going into like a viral pneumonia or another thing. She did not know. She kept increasing her Advair use and was at the top of that. She was doing the duoneb which she did not usually have to do. She had not had to do that since Jan2020 when she had the 5-week flu, or it could have been COVID (they were calling it a hoax back then). She was using her duoneb 4 times a day and now she was using it to 2-3 times, but she was still getting chest tightness, hacky cough. It was kind of like nausea- it was hard to explain, it was kind of like a chest nausea, which she had also had back in Jan2020 when she had the bad flu. She also would get this laryngitis and had trouble talking. With her flare-up, her chest tightness/nausea feeling in the chest continued. Now, she was getting into laryngitis type of thing, but she could loosen that up with her duoneb but if she got to the point where she could not do that, she would definitely have to see someone right away. She clarified that when her chest got tight, the dry, hacky cough continued/increased. When she did the breathing treatment, it loosened it up for about 3-4 hours and some of the pain would go away in her chest. If she talked too much, she would begin to cough. She had had this flare up 3 times in her life, it was not very common. She was diagnosed with asthma in her 40s, and this was her 3rd time ever having anything like this. This was the first time she had experienced a flare up like this. She had had 3 episodes since she had had asthma in her 40's and all 3 bad episodes were about the same. All the episodes were related to illness, it did not just happen out of the blue. It happened with a viral respiratory thing or the flu. The adverse events did not require a visit to the emergency room or physician office. The patient stated that she would call her physician or the clinic "today or tomorrow". She had not been to a doctor since her asthma flared up. Her respiratory doctor/pulmonologist moved away, there was no respiratory doctor nearby right now. So, her general practitioner was following her because it was a mild case and she had mild asthma. If it was severe, her doctor would make her go to a specialist. Relevant tests were reported as no. The patient used to be followed with pulmonary function tests until her respiratory doctor moved away. The patient stated that she took care of her 94 year old mother several days a week and because of all of the variances coming out, she thought it was her civic duty to prevent it from spreading through the population and creating more variances which was why she received the vaccine. She stated her doses were scheduled a month apart because they expecting to get a shipment of Moderna and they did not. They had to run to Buffalo to get the Pfizer vaccine, but they left her doses scheduled a month apart because the appointments were so hard to get. Normally, it would be 3 weeks. Her card clearly said Pfizer and they told her Pfizer, and they told her the reason for it being scheduled at 4 weeks. The patient called to inquire whether asthma flare-ups had been seen in clinical trials. It was not a reported side effect from the paperwork she received. When she looked online, she could not really find anything. She was thinking of going to a clinic but was wondering if there were any reports of flare-ups with asthma with the vaccine. With regards to causality, the patient stated it was a concern because she usually did not get a flare-up unless she was sick. She stated that there were many variables, and that it was spring, and bugs were out, but she did not usually get a flare-up like this. She stated that maybe it was a challenge to her immune system, the antibodies, but she did not know. She suspected the flare-up was related to the vaccine, but she did not have any idea. She would say yes, but she had no way of knowing. The flare-up usually only appeared if she got ill or something weird happened to her. The clinical outcomes of the events flu-like symptoms, fever, achy and fatigue were recovered/resolved on 27Mar2021; sore arm and headache were recovered/resolved on 28Mar2021; asthma flare up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were not recovered/not resolved; she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia were unknown. The reporter believed there was a reasonable possibility that the events sore arm, flu-like symptoms, asthma flare-up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were related to BNT162B2. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information the events asthma flare-ups and viral pneumonia are attributed to intercurrent medical conditions, unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-04-27 fever, respiratory tract congestion, sleepiness, chills, headache aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap... Read more
aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap; She was not able to sleep and did not get up until 10 today; painful and hard; She stated to move her hair even to the touch it is painful; definitely something abnormal; Her hands, mainly her right, and ankles are swollen; Her hands, mainly her right, and ankles are swollen; congested in her chest; she is feeling a little confused; horrendous lumps on her head (some the size of a quarter, some a half dollar; fever; Excruciating pain in my head; peculiar neck pain/ aches and pain in her shoulder and neck; swelling of my arms and hands; Felt Achy; Felt off balance; chills; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included thyroid mass (Diagnosed over 5 years ago. She never got a biopsy of it) , pelvic mass , cardiac disorder (Diagnosed when she was 49 or 50) , cardiac pacemaker insertion. The patient's concomitant medications were not reported. The patient experienced horrendous lumps on her head (some the size of a quarter, some a half dollar on an unspecified date with outcome of unknown , felt off balance on 12Apr2021 with outcome of not recovered , peculiar neck pain/ aches and pain in her shoulder and neck on 13Apr2021 with outcome of unknown , aches and pain in her shoulder and neck on an unspecified date with outcome of unknown , had exceptionally felt like she wanted to go to bed and nap on an unspecified date with outcome of unknown , she was not able to sleep and did not get up until 10 today on an unspecified date with outcome of unknown , painful and hard on an unspecified date with outcome of unknown , she stated to move her hair even to the touch it is painful on an unspecified date with outcome of unknown , definitely something abnormal on an unspecified date with outcome of unknown , her hands, mainly her right, and ankles are swollen on an unspecified date with outcome of unknown , congested in her chest on an unspecified date with outcome of unknown , she is feeling a little confused on an unspecified date with outcome of unknown , chills on 12Apr2021 with outcome of recovered , fever on an unspecified date with outcome of unknown , felt achy on 12Apr2021 with outcome of not recovered , excruciating pain in my head on 13Apr2021 with outcome of not recovered , swelling of my arms and hands on 12Apr2021 with outcome of recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
69 2021-01-03 malaise On 12-21-2020, after the injection patient states she did not feet well and her right index finger b... Read more
On 12-21-2020, after the injection patient states she did not feet well and her right index finger began to hurt right after. She states the right index finger pain started to hurt also on 12-23-2020. She states she will be receiving her second dose on Thursday 01-07-2021.
69 2021-01-03 cough, runny nose Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Staff of nu... Read more
Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Staff of nursing home. Developed cough and runny nose and tested positive for COVID-19 on 12/20/2020. Ongoing exposure to sister who lives with her and is also COVID+
69 2021-01-05 fatigue, headache, malaise Extremely tired, arms and legs felt like lead. Sharp pain top of ankles. Tireness, achiness, joint p... Read more
Extremely tired, arms and legs felt like lead. Sharp pain top of ankles. Tireness, achiness, joint pain, muscle pain, headache. Feeling unwell.
69 2021-01-05 fatigue, sweating, cough, headache, sleepiness, chills Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the... Read more
Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the next morning (12-31-20)with severe chills, headache and dizziness. Felt as if I had covid all over again (was diagnosed with covid on October 12, 2020). My whole body ached and I was extremely fatigued. All I wanted to do was sleep and I also started a slight cough. Later on in the afternoon I started to sweat profusely. I had chills/sweats all through the afternoon and into the evening. I did not even get out out bed until the next afternoon (1-1-21). For 2 days afterwards I had chills/sweats and on 1-2-21 I had terrible stomach cramps and diarrhea.
69 2021-01-07 fever, headache, malaise Injection site is red, swollen, hot. Muscle aches, feverish, headache general malaise. I took Tylen... Read more
Injection site is red, swollen, hot. Muscle aches, feverish, headache general malaise. I took Tylenol, Advil and used ice for the headache.. The side effects didn?t start until day after the vaccine. This is the third day post vaccine side effects are starting to subside.
69 2021-01-07 chills, fever, headache, dehydration fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / receiv... Read more
fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / received the vaccine on 18Dec2020, at that time she only had symptoms of pain; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number CJ1685) via an unspecified route of administration on 18Dec2020 at single dose in the right arm for COVID-19 immunization. Medical history included gum surgery on 29Dec2020. Concomitant medication included amoxicillin trihydrate (AMOCILLINE) from 29Dec2020 post gum surgery. The patient received the vaccine on 18Dec2020. At that time she only had symptoms of pain (onset date 19Dec2020). On the night of 04Jan2021, she had chills and needed 3 blankets and 2 robes. Three hours later her chills were gone and she had a temperature of 105 degrees (fever onset date 05Jan2021). She also had a headache (headache onset date 04Jan2021). She took two paracetamol (TYLENOL) and was unable to sleep until 3:30am. She woke at 9am (05Jan2021). She checked her temperature again and it was 99.2. This was after going 12 hours without taking paracetamol. Then she had body aches (body aches onset date 04Jan2021) but no headache. She thought she was dehydrated and she drank some water. Her headache was gone. She was scheduled for the second vaccine on 08Jan2021. She was told that her body would respond stronger and the symptoms be worse since she responded 17 days after getting the vaccine. The event pain (after vaccination, on 19Dec2020) was resolved on 19Dec2020, chills was resolved on 05Jan2021, fever was resolving, headache was resolved on 05Jan2021, body aches was resolved on 05Jan2021. The outcome of "unable to sleep" and "she thought she was dehydrated" was unknown.
69 2021-01-08 fever, fatigue, chills Nausea Extreme tiredness Body Ache Chills Fever. 100f
69 2021-01-10 fever Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours, moderate relief with Tylenol. ... Read more
Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours, moderate relief with Tylenol. Joint pain for 72 hours with mild relief with Tylenol. Loss of appetite for 24 hours. Left deep armpit pain for 4 days, just subsiding but still evident. Left deltoid injection site warm and red with redness tripling in size over 3 days (covered entire deltoid region.) Site remains warm and red since initial injection but seems to be improving today (day 4 post vaccine)
69 2021-01-11 fatigue Fatigue, Intermittent stabbing pains moving everywhere around my body continuously; skin sensative ... Read more
Fatigue, Intermittent stabbing pains moving everywhere around my body continuously; skin sensative to touch with burning feeling, swollen glands under armpits, neck.. Lasting now over a week. Some lessening with GabaPenton prescription after telehealth consult. His thinking it was neuropathic pain.
69 2021-01-12 fever, chills, fatigue Chills starting about 24 hr after receiving vaccine then a fever of 102 which decreased to 100 by be... Read more
Chills starting about 24 hr after receiving vaccine then a fever of 102 which decreased to 100 by bed time and then was back to normal the next day. Very tiered after fever was back to normal which lasted for aprox. 24 hours. 3 days after vaccine I was feeling fine again
69 2021-01-13 body temperature increased Sore arm; increase in temperature; This is a spontaneous report from a non-contactable other healthc... Read more
Sore arm; increase in temperature; This is a spontaneous report from a non-contactable other healthcare professional (reported for herself). This 69- year-old female patient (reported for herself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EK423), via an unspecified route of administration, on 05Jan2021 at 10:30 AM (at the age of 69-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. The patient does not have any medical history. The patient was not taking any concomitant medications. The patient did not receive any medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jan2021 at 04:00 AM, she experienced a sore arm and an increase in temperature. The patient did not receive treatment for the events. The clinical outcome of the events sore arm and an increase in temperature was recovered. Patient was not tested for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.
69 2021-01-14 cough, fatigue experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pa... Read more
experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pains/aches and pains around her body; severe pain in injection arm; injection site very painful; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She reported that the evening of her first dose, she experienced severe pain in injection arm on 06Jan2021. She stated that night injection site very painful. She had to take Tylenol Extra Strength overnight. She stated that she woke up and she was fine. On 09Jan2021, she reported feeling fatigued, dry cough, extreme fatigue, diarrhea, aches/pains, and aches and pains around her body, but no fever. She woke up this morning on 11Jan2021, experiencing pain in her back where kidneys, still fatigued but no fever. She has taken the Covid test and does not have the results. She wanted to know if these are side effects of the vaccine or is this potentially the Covid virus. The events were assessed non-serious. The outcome of severe pain in injection arm, injection site very painful was recovered, of fatigued was not recovered, of other events were unknown. Information on the lot/batch number has been requested.
69 2021-01-16 headache, fever, fatigue Headache Fever 100.3 Muscle ache Fatigue Pain at injection site
69 2021-01-17 malaise, influenza like illness I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sic... Read more
I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included R.A.D., osteopenia, migraine with aura, the patient had previously suffered episodes of vasal vagal syncopy when she got the flu or other severe illnesses, and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included atenolol, atorvastatin, azelastine, and fluticasone. The patient previously took gramicidin, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced allergies. The morning after receiving the vaccine, she felt quite sick, like she had the flu. When she got up from bed and went to the bathroom to urinate, she became very lightheaded and dizzy. She attempted to return to bed, but passed out on the bedroom floor before she could get to the bed, and seized while she was unconscious. Once she came to, she was helped to bed and, after about 90 minutes, felt much better, and got up, and ate food and had coffee. All events occurred at 07:30 AM on 09Jan2021. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021. Information on the lot/batch number has been requested.
69 2021-01-18 fatigue Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, p... Read more
Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, painful making legs feel like 2 cement blocks to walk. Both shoulders were inflamed and muscles locked causing difficulty in mobility. Both hip joints felt irritated, the left more aggravated and painful. Also the body experienced being tired and sluggishness needing more than usual sleep. This lasting about 8 days. Treatment: ActivIce/Biofreeze spray several times daily and elevation to release pressure and blood flow.
69 2021-01-19 headache, malaise At 1332, she called into the office to let us know that she was not feeling well after her vaccine. ... Read more
At 1332, she called into the office to let us know that she was not feeling well after her vaccine. 1331 2 RN's got to her vehicle to assess her. She stated she was feeling "not right", complained of her left arm hurting, a headache, and right ear pressure. Vital signs at 1339 showed a BP of 138/76 done by manual cuff, a pulse was taken radially and was 78 bpm, with a regular rate and rhythm by palpation, respirations were 26 breaths per minute, and her O2 saturation was 99%. 1342 she had episodes of emesis out the side of her vehicle multiple times. 1344 EMS was called. 1347 50mg of IM Benadryl was administered into her right deltoid. EMS arrived at 1349 and care was transferred over at that time. Her husband took her car keys and was driving separate to Emergency Department.
69 2021-01-19 malaise, sweating, headache, fatigue, chills, runny nose Patient advises that she had developed injection site soreness on the night of her injection. The ne... Read more
Patient advises that she had developed injection site soreness on the night of her injection. The next day, she started with symptoms of generally feeling unwell and headache. She also reports that several days after the vaccine, she had some shortness of breath, dizziness, and weakness but did not seek medical care. Patient states she had fatigue, muscle pain, chills, sweating, and runny nose on 1/15/2021. On 1/18/2021, patient complains of headache. COVID test was ordered and patient was advised to go to Urgent Care for exam if she felt she needed to see a doctor. COVID test resulted negative.
69 2021-01-19 headache, fever Patient describes Soreness at injection site, later experienced body aches, headache, fever that is ... Read more
Patient describes Soreness at injection site, later experienced body aches, headache, fever that is rising and hoarseness in voice
69 2021-01-19 throat pain Pt reports Choking sensation: sore throat "constricting" onset 1523hrs. VS 128/74, puls 77. No other... Read more
Pt reports Choking sensation: sore throat "constricting" onset 1523hrs. VS 128/74, puls 77. No other symptoms observed. Administered 20ml Oral Diphenhydramine. Maintained observation and VS assessment through 1553hrs. Pt reported sore throat but no constricting in throat post Benedryl. Directed to PCP to see allergist before next dose.
69 2021-01-20 headache, fatigue anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; musc... Read more
anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; muscle aches; Loss of taste; Loss of smell; Nausea; sore arm; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EJ1686, intramuscular in right deltoid on 03Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing essential tremor started in her 50's. The patient's concomitant medications were not reported. The patient did not receive other vaccine within four weeks. On 03Jan2021 the patient experienced sore arm and tiredness. On 07Jan2021 the patient experienced anterior cervical fusion and was hospitalized from 07Jan2021 to 09Jan2021. On 08Jan2021 the patient experienced nausea. On 09Jan2021 the patient experienced muscle aches, loss of taste and loss of smell. On unknown date the patient experienced headache. The patient was tested positive to COVID-19 on 11Jan2021. The patient did not visit Physician Office or Emergency Room. Laboratory data included COVID-19 Rapid Test positive on 11Jan2021. The outcome of the events tested positive for COVID-19, and anterior cervical fusion was unknown. The outcome of the events sore arm, tiredness, nausea, muscle aches, headache was resolving. The outcome of the events loss of taste, loss of smell was not resolved.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and COVID-19 test positive on 11Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. This 69-year-old female had medical history of ongoing essential tremor started in her 50's. The reported anterior cervical fusion was most likely due to concurrent disease, and unlikely causally related to the vaccine of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-01-21 throat irritation, cough While half way through eating a Lean Cuisine Butternut Squash Ravioli dinner I suddenly couldn't swa... Read more
While half way through eating a Lean Cuisine Butternut Squash Ravioli dinner I suddenly couldn't swallow. I coughed and threw up what I had eaten. My throat was extremely itchy and my head became very congested. I have never had a food allergy before but after searching that I found the symptoms to be similar. My face was not particularly swollen but I was unable to eat anymore and my throat continued to be very itchy on the right side. I eat mostly on that side due to a dental problem on the left side. I took an antihistamine, gargled with mouth wash, used a Netti Pot and sucked a cough drop. The itchiness was reduced by the next morning and gone by that afternoon.
69 2021-01-22 fatigue, headache Extreme fatigue, headache, dizzy, backache, cold sore. General weakness especially in lower extrem... Read more
Extreme fatigue, headache, dizzy, backache, cold sore. General weakness especially in lower extremities - started 7-10 days after injection.
69 2021-01-24 headache, chills At 6:00 AM, suddenly had severe pain in left side of neck, headache, extreme vertigo, chills and nau... Read more
At 6:00 AM, suddenly had severe pain in left side of neck, headache, extreme vertigo, chills and nausea. Multiple sessions of vomiting. Saw rings of colored lights and squigly lines. Took Tylenol and Benadryl per PCP by phone. Dizziness and chills went away in about 12 hours. Still saw squigly lines at night. Much better the next day but queasy for another 24 hours.
69 2021-01-24 cough Patient complained of lips and throat swelling, she also started coughing (dry cough), blood pressur... Read more
Patient complained of lips and throat swelling, she also started coughing (dry cough), blood pressure high at 189/112. She was given 100mg of Benadryl and an Epi Pen was used. She recovered well with reactions subsiding and blood pressure down to 159/96.
69 2021-01-24 headache, chills Rapid heart beat in chest, neck and head, Elevated blood pressure Pounding head ache Chills with unc... Read more
Rapid heart beat in chest, neck and head, Elevated blood pressure Pounding head ache Chills with uncontrollable shaking
69 2021-01-25 headache, influenza like illness, sweating, dehydration, chills 2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vom... Read more
2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vomiting 3:00-extreme headache (took aspirin for pain) -lower back hurt -pain in right shoulder, elbow, wrist -couldn?t lay on right side (bruising at site but no swell -couldn?t move without vomiting -woke up at midnight completely wet with sweat and sweating continuing even today Tuesday -weakness all over (felt like I had had the FLU) ? I knew there was potential for side effects before taking the vaccine...I was totally unprepared for so many symptoms and how intense they were and what little I could do to relieve any of them. Never had fever that I am aware of. Today I?m weak and sweating is unreal. ?? Should I prepare/expect my second dose around Feb. 14 to have the same effect on me.? Not looking forward to that. I was almost ready to go to the ER I was getting so dehydrated and weak.
69 2021-01-25 headache, throat pain, chills, fatigue sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme f... Read more
sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme fatigue, swollen lymph nodes, increased blood pressure, night sweats
69 2021-01-26 fever, chills, cough, fatigue HPI: 69 y/o woman with minimal PMH of hysterectomy and cystic mass resection in 2016. She presented ... Read more
HPI: 69 y/o woman with minimal PMH of hysterectomy and cystic mass resection in 2016. She presented with c/o fatigue, fevers, shaking chills, SOB/cough, anorexia, N/V/D for the past 6 days (GI symptoms started 2 days ago). Husband reports she has also had periodic confusion during this time. She received her second COVID vaccine 7 days ago and symptoms started the following day.
69 2021-01-26 headache Imediately after receive injection left eye is RED and mild headache.
69 2021-01-26 fever She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was s... Read more
She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was sent to ER for evaluation of leg weakness.
69 2021-01-26 fever, headache, malaise first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headac... Read more
first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headache, felt under the weather. Third day more swelling, redness and headache. Today, forth day, swelling going down still red, no headache and feeling better in general. Took tylenol for headache and pain.
69 2021-01-27 fever, chills, headache, sweating 1st shot...none 2nd shot: 1st night-fever, headache, chills major all over stiffness ... Read more
1st shot...none 2nd shot: 1st night-fever, headache, chills major all over stiffness 2nd night- fever over 100 degrees, major chills and shivering, joint stiffness, no headache 3rd night- no fever but MAJOR sweating, sweating, sweating. No headache, stiffness much improved. 4th day - all symptoms almost gone, no headache, stiffness improved. Arm still sore
69 2021-01-27 headache, influenza like illness, fever, chills After about 12 hours I started having muscle aches in both arms which then became full body ache lik... Read more
After about 12 hours I started having muscle aches in both arms which then became full body ache like flu symptoms. Fever chills during the night. Still had 99.5 fever at 7 this morning and dull headache. Took 2 Tylenol. Still sore but getting better.
69 2021-01-27 headache, fever, chills blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizzin... Read more
blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizziness; extreme debilitating aches and pains; body felt numb; fever; chills; This is a spontaneous report received from a contactable nurse (who is also the patient). A 69-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: RH9899, expiry date: unknown), intramuscular in left arm, on 21Dec2020 09:30, at single dose, for COVID-19 immunization. Medical history included allergies to shellfish and bee stings. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and is not pregnant. On 23Dec2020 at 20:00, the patient experienced headache, blurred vision that lasted nearly two weeks, extreme debilitating aches and pains, body felt numb, bedridden due dizziness, fever and chills. Treatment for the events included ibuprofen (ADVIL). The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. The reporter assessed this case as non-serious.
69 2021-01-28 fatigue Extreme fatigue for 2 days
69 2021-01-28 chills, fever, headache Fever up to 101.6, chills, headache, muscle soreness
69 2021-01-28 chills Nasuea, Chills, Joint aches
69 2021-01-28 headache body aches increased; headache worse; This is a spontaneous report from a contactable consumer (pati... Read more
body aches increased; headache worse; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (reported as injection) in the left arm on 08Jan2021 at a single dose for COVID vaccine due to the patient's age and lives in continued care retirement community. Medical history included ongoing pain and ongoing persistent headaches, both since 2009. Concomitant medication included erenumab aooe (AIMOVIG) from an unspecified date in 2020 (started taking it 3 months ago). The patient reported side effect from the vaccine received on 08Jan2021. She has had body aches and headaches since 2009, so she figured after reading about the side effects, she would probably have worse body and headaches, but the body aches lasted maybe 4-5 days, from the time of vaccination, she has what was called new daily persistent headaches, which was a rare form of headache. They didn't have meds for it, because not many people have it, it was not a money maker to try to find something that works. She figured this would make headache worse and that was what it did, they were normally a level 7 or 8 on an unspecified date, and they increased to a level 9 on Jan2021, and she couldn't find a way to get it back down. The patient called her headache specialist and she thought steroid injections might help but wanted her to talk to someone to let them know the side effect the patient was having, with the headaches. Her body aches never go away, headaches never go away, and the day of the vaccine, she still had them both as normal, but after receiving the vaccine, her body aches increased, they went up a level, they were normally, a level 7 on an unspecified date, and after the vaccine, they went up to an 8.5 on Jan2021. She took Tylenol, regularly, every 4 to 6 hours, and after about 4 days, the body aches were down to the normal ache. But, the headache did not. The headache was starting to get worse. The outcome of the event body aches increased was recovering while the other event was not recovered. Information on the lot/batch number has been requested.
69 2021-01-28 fatigue, malaise, dehydration, sleepiness, fever temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off;... Read more
temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off; first it was up around 163/71 and then over time it was really low 118/58; HR was high; body was jerking; arm that she got the injection in was dropping; dehydrated; urine is darker; real thirsty; extremely weak; tired and exhausted; feeling horrible; couldn't stay awake, fell asleep; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included left hip replaced on 16Nov2020 and had her right hip replaced on 29Dec2020. There were no concomitant medications. Patient reported that she got the shot at 1:30 pm and on the way home she started getting tired and exhausted on 14Jan2021. She got home and went right to bed. She felt like she couldn't stay awake, fell asleep and woke up about 6 pm then with a temperature of 105.5 and stated it would fluctuate between 104-105. She was just feeling horrible. At 7:30 pm, patient had a temperature of 103.5 and at 7:45 pm, her temperature was 104. On 14Jan2021, patient stated that she couldn't see straight, had blurred vision, having trouble walking, her balance was off and falling into walls. Her body was jerking and the arm that she got the injection in was dropping. Patient called her cardiology office, and was advised to take Tylenol 3-4 times per day and alternate it with Motrin. She was also taking coated 325 mg aspirin. She can hold her head up and was not jerking as much as she was. She was doing noticeably better. Patient had put ice bags on her groin, stomach and throat to try to cool down through the night. This brought temperature down to 103. She woke up at 12 am she was 102. Her temperature at the time of report was around 101-102. She took her blood pressure it was going crazy, first it was up around 163/71 and then over time it was really low 118/58 and heart rate was 130 for a while and went to 103. The back of her neck still felt so weak and she still feels extremely weak and exhausted. She went on to report that her HR was high and B/P was up but since then it has come down. The night of 14Jan2021, her b/p was low.On 14Jan2021, patient was also real thirsty and her urine was darker and was probably dehydrated and thought that she was real jerky muscle-wise, like she is not in control of anything last night. That she has not taken BP or heart rate on 15Jan2021, but it was not pounding today though. She was doing better today at the time of report. Patient was recovering from the events of fever, blurred vision, and balance was off; not recovered from tired, jerking, and dehydration. Outcome of remaining events was unknown.
69 2021-01-29 fatigue, chills I felt dizzy, tired and had chills. I rested overnight and feel fine now.
69 2021-01-29 fatigue, chills, headache, fever Mild pain, headache, chills, and abdominal pain. Mild-moderate fever 102.3. Moderate fatigue.
69 2021-01-29 headache, fever Moderate headache and fever for 12 hours
69 2021-01-29 fatigue, headache Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away withi... Read more
Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away within 30 minutes. But 2-3 hours later three fingers had peeling. Also wrinkly fingers. Increased water and added electrolytes. Notified doctor, who instructed to elevate and ice arm, and to start benadryl. Also take benadryl before next vaccine. Left arm may still be slightly swollen, but most swelling gone by 12 hours. Sore arm for a couple days, intermittent headache which took tylenol for. Fatigue, still.
69 2021-01-29 headache sore arm, headache that night, nausea the following day.
69 2021-01-30 headache Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin,... Read more
Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin, Zofran, chicken broth for electolytes> Signs included hypotension, nausea, headache, weakness, I am a retired doctor married to an Endocrinologist and living to take care of my 2yo grandson for my daughter who is a resident in PEDS , I and my family are very familiar with managing my illness, which infrequently presents with crisis and I very rarely must be hospitalized .
69 2021-01-30 headache, body temperature increased Had chills all night - from ~ 5pm until 5am on the 30th. @ 5 am om the 30th - I had intermittent p... Read more
Had chills all night - from ~ 5pm until 5am on the 30th. @ 5 am om the 30th - I had intermittent periods of chills - but much less severe. Also had a temp of 100,2 w/ slight headache. Started taking tylenol about 3 am on the 30th.; then every 6 hours after. Did stay in bed - slept basically until 9am - this date 1/31/21. Although I think this was a "normal" reaction - just thought I should report it - to add to generally data about the vaccine.
69 2021-01-31 influenza like illness, fever Got the flu like body aches; Got 100 temperature; Had a sore arm but it was mild; Started hurting a ... Read more
Got the flu like body aches; Got 100 temperature; Had a sore arm but it was mild; Started hurting a little bit more; This is a spontaneous report from a contactable nurse, the patient. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248; Expiration Date: Apr2021), intramuscular in the right upper arm on 15Jan2021 at 12:30 (at the age of 69-years-old) as a 0.3 ml single dose for COVID-19 immunization. Medical history included atrial septal defect, palpitations, and COVID-19 from Aug2020 to an unknown date. The patient had COVID antibody titers done in Aug2020 and Dec2020 and they were "270." Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), cyanocobalamin (B12-VITAMIIN), estrogens conjugated (PREMARIN), pravastatin (MANUFACTURER UNKNOWN), and escitalopram oxalate (LEXAPRO). On 15Jan2021 after getting the vaccine, the patient had a sore arm but it was mild. Then as the night went on, it started to hurt a little bit more. On 16Jan2021, the patient had flu like body aches, and had a temperature of 100. The patient did not receive any treatment for the events. The clinical outcome of the sore arm that hurt a little bit more was not recovered; while that of the flu like body aches and a temperature of 100, were unknown. The nurse thought the events were related to the vaccination.
69 2021-01-31 malaise, cough, fever, fatigue, headache feeling ill; headache; fever; tired; a slight cough; Nausea; Just an overall feeling of being sick n... Read more
feeling ill; headache; fever; tired; a slight cough; Nausea; Just an overall feeling of being sick not feeling well; Pain in my back that radiated between my shoulder blades and down and to my lower back like crossed my kidneys; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via an unspecified route of administration at Right arm on 12Jan2021 10:00 at SINGLE DOSE for COVID-19 vaccination. Medical history included diabetic, high blood pressure and possible Atrial fibrillation (AF). Concomitant medications in two weeks included lisinopril, atorvastatin, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient started feeling ill the day after the shot, she had a headache, fever, tired, a slight cough, Nausea, Pain in her back that radiated between her shoulder blades and down and to her lower back like crossed her kidneys. Just an overall feeling of being sick not feeling well. She was questioning whether she may have been exposed to Covid and she was experiencing Covid symptoms. The events started from 13Jan2021 01:00 AM and not recovered at the time of reporting. No treatment received, no covid prior vaccination, no covid tested post vaccination, no known allergies.
69 2021-02-01 chills, fever 2:AM on Feb 18 started chills while sleeping. Had hot tea and blankets and it subsided. fever of ... Read more
2:AM on Feb 18 started chills while sleeping. Had hot tea and blankets and it subsided. fever of 100-101 throughout the day. Sleeping. Pain at injection site . Symptoms lasted about a day and a half. This was the first dose!
69 2021-02-03 fever, chills Constipation began early evening; Chills and fever began around 8 p.m. same day as the inoculation.
69 2021-02-03 fever, malaise, influenza like illness, headache, fatigue, chills INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, FEVER, INJECTION SITE SWELLING, INJEC... Read more
INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, FEVER, INJECTION SITE SWELLING, INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL FLU LIKE SYMPTOMS
69 2021-02-03 fatigue, malaise Injection site soreness; tiredness; muscle pain; feeling unwell; This is a spontaneous report from a... Read more
Injection site soreness; tiredness; muscle pain; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 14Jan2021 at 09:00 at a single dose in the hospital for COVID-19 immunization. Medical history included autoimmunity of unknown origin and seafood allergy. The patient is not pregnant at the time of vaccination. Concomitant medication included folic acid, methotrexate, multivitamins (vitamins nos), and fluoxetine hydrochloride (PROZAC). The patient experienced injection site soreness, tiredness, muscle pain, feeling unwell for 30 hours on 14Jan2021 at 12:00. The patient did not receive treatment for the events. Outcome of the events was recovered on 15Jan2021. Information on batch/lot number was requested.
69 2021-02-03 headache PT complaining of Headache and Dizziness post vaccination. After Evaluation PT states symptoms have... Read more
PT complaining of Headache and Dizziness post vaccination. After Evaluation PT states symptoms have resolved and refused treatment or transport.
69 2021-02-03 chills, fatigue, headache, fever Temperature of 101.5 -- chills - headaches - shoulder & neck pain - muscle pain - fatigue - vomiting... Read more
Temperature of 101.5 -- chills - headaches - shoulder & neck pain - muscle pain - fatigue - vomiting Feeling better on day 2
69 2021-02-03 throat irritation The patient was referred by her primary care provider's office to receive COVID-19 vaccination. She ... Read more
The patient was referred by her primary care provider's office to receive COVID-19 vaccination. She received her first dose of Pfizer-BioNTech COVID-19 vaccine at approximately 15:07 hrs. Due to her history of allergic reactions to multiple medications (including sulfa antibiotics and ceftriaxone), she was advised to extend her monitoring period to at least 30 minutes post-injection. At around 15:50 hrs I was notified that the patient was feeling a tingling sensation in her throat, itching, and a change in her voice. She was transferred to a stretcher for acute management of suspected anaphylaxis. Airway, breathing, circulation, and mentation were assessed immediately. EMS was called immediately via 911. Her vital signs were obtained, with a BP 168/90 mm/Hg, HR 105/min, RR 24/min. She reported shortness of breath at the time. There was no stridor or wheezing on exam. She appeared in mild respiratory distress. At 15:54 hrs she was given an intramuscular EpiPen injection (0.3 mg autoinjector) in her left thigh. At 15:58 she was given an intramuscular methylprednisolone injection (125 mg) in her right thigh. Immediately after that EMS team arrived and took over her care with plans to administer diphenhydramine intramuscularly, and will transfer to ED for further management. Throughout the event the patient remained awake, alert, and fully oriented.
69 2021-02-03 lethargy, headache a background headache all day; lethargy; bit of fogginess; This is a spontaneous report from a cons... Read more
a background headache all day; lethargy; bit of fogginess; This is a spontaneous report from a consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration, in the right arm on 15Jan2021 at 15:30PM (at the age of 69-year-old) as a single dose for COVID-19 immunization. Medical history included just sensitivities, not allergies, to NSAIDS and some pain meds. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medication taken within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on the first day nothing. On 16Jan2021, the second day (as reported), the patient experienced lethargy and a bit of fogginess. The third day, 17Jan2021, the patient had a background headache all day. The events were reported as non-serious. The patient finally took (acetaminophen) TYLENOL before bed, for the headache, waking on the fourth day feeling normal. The clinical outcome of the events lethargy, bit of fogginess, a background headache all day was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
69 2021-02-03 headache, fever, influenza like illness dizziness/dizzy; little headache; felt like she had the flu/flu-like symptoms; body aches; low grade... Read more
dizziness/dizzy; little headache; felt like she had the flu/flu-like symptoms; body aches; low grade fever that never went over 101.4/low grade fever between 99.6 and 100; red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised/rash was across her chest, breasts, and above her belly button, but not on her back; pain in her right arm which got stronger at the injection site overnight/sore arm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date: Apr2021), via an unspecified route of administration on 15Jan2021 at 12:30 at a single dose on the right arm for COVID-19 immunization. The patient has a medical history of having covid infection in Aug2020 where her symptoms were low grade fever and headaches only. The patient also stated that when she gets a virus, she always gets this kind of rash. The patient is in an ongoing year -long antibody study where they check for antibodies every 3 months. The results of the 1st titre was 270 after her 10-day quarantine period, and in Dec2020, it was still 270. There were no concomitant medications. The patient reported that she had a sore arm on Friday, the day of the vaccination, 15Jan2021. She experienced pain in her right arm which got stronger at the injection site overnight. Then on Saturday 16Jan2021 at 11:00 AM all her symptoms started. She developed a low grade fever that never went over 101.4, a little headache, dizziness, and body aches. She stated that it was weird because she rarely gets sick, but she felt like she had the flu. She is getting a low grade fever between 99.6 and 100, flu-like symptoms and was dizzy. Then on the night of Saturday 16Jan2021, when she went to bed she had a red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised. The rash was across her chest, breasts, and above her belly button, but not on her back. The patient reported that she still has the rash, and that it has actually gotten worse; it's spread more across her whole chest which is typical. Since when she gets a virus, she always gets this kind of rash; it doesn't itch; it's just kind of there and it's always in the same place whenever she gets it. The outcome of the event 'red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised/rash was across her chest, breasts, and above her belly button, but not on her back' was not recovered while the outcome of the other events was unknown.
69 2021-02-04 fever, chills Fever of 103.7, vomiting, diarrhea, myalgia, shaking chills, called 911
69 2021-02-04 throat irritation, cough Pt C/o coughing, SOB,and throat irritation 25 minutes after the vaccine was administered. Also repo... Read more
Pt C/o coughing, SOB,and throat irritation 25 minutes after the vaccine was administered. Also reported that her throat and neck felt swollen and tongue began to feel "thick".
69 2021-02-04 headache Today I have muscle and joint pain, a headache and nausea
69 2021-02-04 headache slight headache, slight, nausea, chilling
69 2021-02-06 headache Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to... Read more
Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to my shoulder. By the next day, it was really painful in my shoulder and across my back almost to my backbone. It was painful to move my arm up or down or to reach for things. This lasted 3 to 4 days. Then my neck on the same side as the shot (left) began to hurt so badly I couldn't move my neck up or down or sideways. It was strange the way the pain slowly moved across by arm to my shoulder to my back and up my neck. I've never experienced anything like this before. Today my pain in my neck is bearable but I have soreness and a headache. I hope I am at the end of the cycle to this event as I am scheduled for my next shot soon.
69 2021-02-07 fatigue, nasal congestion felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoi... Read more
felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoing congestion in one nostril/stuffiness; felt tired and run down; feeling itchy/Her head, neck and back are very itchy; rash/like a fever type rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3249, unknown expiration), via an unspecified route of administration in the left shoulder area on 16Jan2021 at 11:15 AM at a single dose for COVID-19 immunization. Medical history included COPD (has it for lots of years) and nickel sensitivity. She does not have any reactions to her previous unspecified vaccines but had a normal reaction like sore arm. Concomitant medication included bimatoprost (LUMIGAN). The patient previously received flu vaccine and pneumonia vaccine, both for immunization in 2020 around the end of Sep or beginning of Oct. The patient reported side effects regarding the COVID vaccine and said she was a little confused and unsure if she was having a problem or if she should see a doctor. On 16Jan2021 at 11:15 AM, she had the first dose of the COVID vaccine and afterward she had a lot of effects which were mostly muscle and body aches in Jan2021. She also experienced some ongoing congestion in one nostril but saw this as just more congestion and that she was having to blow her nose more in Jan2021. She did the (app name) report but didn't report the stuffiness. She did report that in the first few days she felt like she was having the onset of pneumonia and felt tired and run down (Jan2021). Two days ago, she started feeling itchy (Jan2021) and she didn't know what it was, she didn't know if she ate something or what. Now she has developed a rash (Jan2021) which is ongoing until now. Her paperwork said the rash would happen right away if it was caused by the vaccine. The patient wanted to know if this is something she should be concerned about and if the rash could appear or started this long after she had the vaccine. Her second dose is due on 06Feb2021. The patient wanted to know if the vaccine contains nickel or any metal substances in it since she had compared her rash to her nickel sensitivity. The patient wanted to know if rash is a side effect from the vaccine and how long it will last. She didn't put rash down for the safety check either as she didn't know if it was caused by the vaccine. Today her rash, she is so itchy. She does have it on her neck and certain areas but not everywhere. It looks like what would happen after a bad fever. It is not raised but is like a fever type rash. She did note that she had an increase dose of a medication eye drops (Lumigan; Lot: T and a 0 or O followed by 544, and NDC: 0023320503. Expiry: Jan2022) around the time the rash started but after getting the vaccine. Her head, neck and back are very itchy. She mentioned that she waited 2 days and did not put this event in the (app name). She would have reported it yesterday, but she didn't get one yesterday. She also noted that it was very dry there and cold and a person is going to get dry skin. She does have an allergic to metal and wondered if that was in the product. In her neck area, it looks just like when she would wear a cheap necklace. No treatments received. The events did not require emergency room or physician office visit. The patient has no prior vaccination within four weeks. The patient had not yet recovered from events rash/like a fever type rash and congestion in one nostril/stuffiness; while unknown outcome for the remaining events.
69 2021-02-09 headache, fever, chills Pain through back across both arms and neck.; A headache that feels like my heads going to explode.;... Read more
Pain through back across both arms and neck.; A headache that feels like my heads going to explode.; swell up like a balloon; Nauseated; Chills; fever; Pain on both my legs cannot walk; Pain through back across both arms and neck. Cannot lift my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the right arm on 20Jan2021 16:00 at single dose for covid-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing , hypersensitivity (Known allergies: Yes) from an unknown date and unknown if ongoing, covid-19 (if covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Concomitant medications included unspecified medications. The patient experienced pain through back across both arms and neck, the patient cannot lift their arms. The patient also experienced pain on both their legs cannot walk, a headache that feels like their heads going to explode, nauseated all the time, swell up like a balloon, chills and fever. It was reported that the events occurred on 21Jan2021. Therapeutic measures were taken as a result of pain through back across both arms and neck. The patient did not recover from the events. Information on the lot/batch number has been requested.
69 2021-02-09 fatigue Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (... Read more
Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 14:30 at a single dose, for COVID-19 immunization. Relevant medical history included allergies to sulfa drugs. Concomitant medications included escitalopram, alprazolam, paracetamol (TYLENOL), simethicone (GAS X), and vitamin D. The patient previously took aspirin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Facility. On 12Jan2021, at 14:30, the patient experienced soreness at shot site, fatigue, and migraine. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination. Information on the lot/batch number has been requested.
69 2021-02-09 chills, nasopharyngitis, fever, fatigue This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A... Read more
This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (EL8982) via an unspecified route of administration on 21Jan2021 12:30 at single dose in left arm for COVID-19 immunisation. No additional vaccines administered on same date of Pfizer suspect. Medical history included COVID-19 virus from Jun2020 to an unknown date. There were no concomitant medications. The patient reported fever, joint pain and tiredness, experienced fever, cold and chills after the first dose, all on Jan2021. She was asking how long these symptoms usually persist. The patient received COVID shot last Thursday. Had chills, fever, ugly fever blisters, and fatigue. The patient asked how long does the fatigue stay in the system because she is really tired. She was tired since 22Jan2021. She had chills on the night of 22Jan2021. She is done with fever and chills, she is just tired. Had COVID-19 virus in Jun2020. Feel like she has it again. The temperature was 99 degrees, began on night of 22Jan2021. Fever blisters started on 23Jan2021 reported as are subsiding, but still present. She was still really tired. Woke up Saturday and thought she had COVID-19 virus all over again. The events did not require visit to AES, because she was ok. Event outcome of fever blisters was not recovered, while for others was unknown.
69 2021-02-09 nasopharyngitis, fever, fatigue, chills cold; Fatigue; Chills; Fever; This is a spontaneous report from a contactable consumer (patient) via... Read more
cold; Fatigue; Chills; Fever; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 69-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL8982) at left arm, via an unspecified route of administration on 21Jan2021 13:30 at single dose for covid-19 immunisation. Medical history was none. Prior vaccinations (within 4 weeks) were none. Family Medical History Relevant to adverse events was none. There were no concomitant medications. The patient experienced chills on 22Jan2021, fever on 22Jan2021, fatigue on 23Jan2021, cold on an unspecified date. The patient received no treatments. The patient had the Pfizer shot last Thursday (21Jan2021) and afterward had chills and fever. Now she was so tired. The events did not require a visit to Emergency Room or Physician Office. The patient's weight was 145-150 lbs. The outcome of events chills and fever was recovered on 23Jan2021; of fatigue was not recovered; of cold was unknown.
69 2021-02-09 productive cough right ear began to hurt; eustachian tube inflammation; slight vertigo; metallic taste in mouth; phle... Read more
right ear began to hurt; eustachian tube inflammation; slight vertigo; metallic taste in mouth; phlegm drainage in throat; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 20Jan2021 (15:00) at single dose for Covid-19 immunization. Medical history included penicillin allergy (Known allergies: penicillin, ciprofloxin, levofloxacin, hylan G-F, lexapro, bacitracin). Concomitant medication included potassium chloride. The patient previously took Ciprofloxin, Levofloxacin, Hylan G-F, Lexapro, and Bacitracin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (10:00), the patient began to experience slight vertigo accompanied by metallic taste in mouth and phlegm drainage in throat (reported as "phlym"). When she laid down in bed at right side mainly her vertigo got worse. Late Saturday afternoon (23Jan2021), her right ear began to hurt. She went to urgent care at 7:30 pm. The doctor prescribed vertigo exercises, Flonase nasal spray for possible eustachian tube inflammation and ibuprophin. On Sunday (24Jan2021: today), the patient was still experiencing pretty severe vertigo; not much improved. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had vertigo exercises, ibuprophin, and Flonase spray as treatment. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination.
69 2021-02-10 runny nose, chills, nasopharyngitis, fever Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; co... Read more
Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.
69 2021-02-10 dehydration, malaise, fatigue, sleepiness, chills, fever, headache deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache... Read more
deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache; body aches; fatigue; dizziness; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; will fall asleep through the day for 3-4 hours at a time and she does not even nap usually; Muscle pain; Neck ache; Backache; Problems with walking; problems with balance; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3246), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a single dose for covid-19 immunization. Vaccine was not administered in a military facility. Medical history included ongoing ulcerative colitis, ongoing high cholesterol, ongoing high blood pressure, celiac disease from 2005 (this has been tested too many times to count and it has been negative since after initial diagnosis 2005), arthritis (all her life) ongoing, hip replacement surgeries first done in 2005; repair of same hip in 2015; other hip in 2017. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines include Pneumonia Vaccine, Shingles Vaccine and Flu vaccines; all on an unspecified date for immunization. She never had adverse events with those. Ongoing concomitant medications included rosuvastatin (5 mg tablet) for high cholesterol, mesalamine (400 mg capsule) for ulcerative colitis and lisinopril from 2018 for high blood pressure. According to the patient, she knows that mesalamine is an immunosuppressant and anti-inflammatory to keep inflammation in the colon down. This consumer was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021 14:30 with immunosuppressant mesalamine. The night of 14Jan2021 patient had headache, chills, body aches, diarrhea, fatigue, fever and dizziness like Covid 19 symptoms. She went to the ER during the past 11 days for IV fluids due to deyhydration from the diarrhea. Today, 25Jan2021 is the first day she has been out of the house, except to go to the ER, since she received her 1st vaccine dose. On Jan2021 muscle pain, neck ache, backache, problems with balance and problems with walking. Events probably started with intense diarrhea starting 14Jan2021; then Fever over 102 degrees Fahrenheit and chills 14Jan2021; Specific onset dates and onset times unknown otherwise other than between 14Jan2021 and 16Jan2021 onset dates. It was a rolling week of agony after that with one adverse event after another until she ended up in the emergency room on 16Jan2021 because she was so dehydrated and was really sick. She was not admitted to the hospital related to any of these events; but while in the emergency room she was given intravenous fluids; a chest x-ray; blood work; after maybe 5-6 hours she was sent home; she was also given a COVID test which was negative; and then 2 days later took another COVID test which was also negative. Both COVID tests were Rapid Tests: on 16Jan2021 and 18Jan2021. On the Chest xray they suggested she had some sinus tachycardia which is just a rapid heartbeat and not surprising; nothing else showed up on Chest x-ray; as far as anything else testing/results wise there was only some facetious blood work which they just said to follow-up with her PCP regarding but nothing really out of the ordinary. She can finally out of bed on a regular basis for a couple of hours daily; she is still very fatigued; she has no muscle pain, neck aches or body aches at this time; she does not have the strength she should have; is no longer experiencing headaches or fever; but is extremely tired. She will fall asleep through the day for 3-4 hours at a time and she does not even nap usually (Jan2021). She has not driven yet but assumes probably once she is a little stronger she will be able to drive again. She did not have upper respiratory, chest or cough issues. The outcome of the events fever, headache, body ache, muscle pain, neck ache was recovered on Jan2021; fatigue was not recovered. The outcome for the other events was unknown.
69 2021-02-11 headache Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over he... Read more
Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over her chest, light headed, patient said she feels like she was going to pass out immediately after vaccine administration. VS 100/60 mmHg, pulse 64, RR 22. Patient complaints of headache, nausea and skin clamy and warm. Site manager made aware, o2 @ 2 L via nasal cannula administered. EMS transport to hospital. Daughter was made aware via VM, unable to reach 3x attempts.
69 2021-02-16 fatigue Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funn... Read more
Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funny; Head spinning; Weakness; nerve pain; stomach nausea; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration, in the right arm, on 16Jan2021 14:15 at a single dose for covid-19 immunization. Medical history included left-sided breast cancer from 2005 and lymph nodes removed on her left side. Concomitant medications included pravastatin and a lot of vitamins. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccine administered on same date of the Pfizer suspect. It was reported that the patient took first shot and got anxious on 16Jan2021. The patient also experienced a lot of fatigue on 16Jan2021, went home and got worse then was hospitalized. The patient had a virtual visit with her doctor and wanted some advice, and her doctor didn't give her any prescriptions. The patient also felt something in her chest area on 16Jan2021, after receiving the COVID-19 vaccine. Events anxious and fatigue required emergency room visit. The patient was hospitalized from 25Jan2021 to 27Jan2021 for the events anxious and fatigue. The patient also experienced head spinning, chest feeling funny, weakness and stomach nausea on unspecified date in Jan2021. Reported she was given all kinds of medicine in the hospital. She said as long as she was laying down, she was good. She said once she got up, and moved around, she felt the weakness again. She said she was put on depression medicine (Jan2021) while in the hospital, and was given 4 different prescriptions at discharge. She said the only thing that helps her go to sleep at night is a 1/2 tablet of generic alprazolam for anxiety. She said she knows she can't stay on the generic alprazolam forever, clarifying that is why the doctor put her on the depression medicine. Reported she was given the following medications in the hospital, as well as, prescriptions to continue the medications at home after her hospital discharge: escitalopram 10mg for depression. She said she is to take one escitalopram 10mg every evening for 30 days. She said she was given escitalopram 10mg for the two days she was in the hospital. Generic gabapentin 100mg for nerve pain (Jan2021) and she is to take 1 capsule nightly for 30 days. She said she started the gabapentin 100mg while she was in the hospital. Pantoprazole 40mg, she was given a one-time small IV bag of pantoprazole 40mg for her stomach while she was in the hospital (clarified she was given on 27Jan2021 at 05:26). She said she was having some stomach nausea (Jan2021), and the pantoprazole 40mg was to protect her stomach. She said she told the doctor she didn't want to take the pantoprazole 40mg any longer because she thought she was being given too many different medicines. Reported her fatigue is not the same as it was when she went to the hospital, but the fatigue is still there. Reported her lab work (Jan2021) was good, and her test results were fine when she was in the hospital. She said she was told she was 30% from being on the verge of having heart disease. She said her doctor told her the heart disease was preventable if she eats right, and makes some other changes. She said her cholesterol has gone done. She said she just has the fatigue, and that was why she was put on medicine. Therapeutic measures were taken as a result of the event anxious, fatigue, nerve pain and stomach nausea. Outcome of the event fatigue was recovering while it was unknown for all the other events.
69 2021-02-17 headache Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache;... Read more
Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9263 and expiry date unknown) on 26Jan2021 18:00 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included Lupus, Lyme disease, hypothyroid, Meniere's, and sulfa allergies. The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included levothyroxine (LEVOTHYROXINE), acyclovir (ACYCLOVIR), ezetimibe (EZETIMIBE), hydroxychloroquine (HYDROXYCHLOROQUINE). No other vaccine received in four weeks. The patient experienced adverse events from 20:00 on 26Jan2021. She experienced sore arm, radiated to shoulder, then to back toward backbone, then up back and side of neck. It's very painful. On 07Feb2021 ("today"), her neck pain was better but she had a headache. These events took place ongoing for several days after and since she had the vaccine. It was reported that the events resulted in Disability or permanent damage. The patient did not receive treatment for the events. The outcome of the events was provided as recovering.
69 2021-02-21 headache A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was... Read more
A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was extremely achy. It was still happening as of Saturday, I also felt lightheaded. I felt like a was on a merry-go-round, it felt like it kept getting faster and faster. I felt dizzy all day Saturday. I had to rest all day. I lost my appetite. Anytime I got up to go to the bathroom, I had to hold something to walk. I also had a mild headache. I felt better on Sunday. My arm was still a little sore as of yesterday but it is better today.
69 2021-02-21 fatigue After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this ... Read more
After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this past two weeks. I experienced nausea, dizziness, felt like my brain was on fire. Last week I could not comprehend what people were saying, I did not understand. Extreme irritation, anxiety, depression. Fatigue and tiredness, my legs are weak. My blood pressure went skyrocketed: 169/80.
69 2021-02-21 chills, fever Chills, body aches, fever, sore arm
69 2021-02-21 headache During sleep time kept waking up and feeling like I was going to vomit. Headache.
69 2021-02-21 fever, headache Fever of 102 degrees, headache lasting for 12 hours. Tylenol taken.
69 2021-02-21 fatigue Patient received first dose of Pfizer Covid vaccine at 13:00 at vaccination clinic on 2/21/2021. Pa... Read more
Patient received first dose of Pfizer Covid vaccine at 13:00 at vaccination clinic on 2/21/2021. Patient began to complain about feeling tired and wanted to take a nap later in the afternoon. Patient's husband found patient at 16:30 almost unresponsive and checked a BG reading which resulted at 25. Husband gave patient oral forms of sugar and transported to ER where he BG slowly normalized. Husband reports patient has been a well controlled diabetic and has never has an incident like this happen previously.
69 2021-02-21 fever, chills, headache chills; fever; body aches; headache; vomiting; This is a spontaneous report from a contactable consu... Read more
chills; fever; body aches; headache; vomiting; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a sngle dose for covid-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. She mentioned that she received the vaccine on Sunday (unknown date) and reported that for the last 4 days she had been pretty sick with fever, chills, headache and body aches. She had been alternating acetaminophen (TYLENOL) and ibuprofen (ADVIL). She did have COVID in Nov2020. The patient inquired if the symptoms after dose 2 would be worse if she's had COVID in the past. She also inquired if she will have the same symptoms for the second dose and if how long side effects will last. She add that she did have some vomiting on Sunday later after she got the vaccine. She was wondering because she is to get the second dose on the 21st, the pharmacist did say that sometimes people who have had the Covid virus already can sometimes experience strong side effects from the vaccine. She does not want to feel or get sick. The outcome of the events was unknown. Information on the lot/batch number has been requested.
69 2021-02-22 fatigue, headache Fatigue, headache, diarrhea
69 2021-02-22 fever, fatigue Sore arm, slight fever (100.6), fatigue, slight intestinal distress
69 2021-02-22 headache, fever, sweating, chills sore arm - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hr... Read more
sore arm - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hrs later and persists still chills and sweating - started about 36 hours later and persists still stomach ache and diarrhea - started the 15th, worsened over days and still persists fever - although I felt like I had a fever i did not record a fever until the 21st-22nd--it was 100.2
69 2021-02-23 fever, chills, headache Chills; Fever of 100.2; Headache; Muscle ache; This is a spontaneous report from a contactable consu... Read more
Chills; Fever of 100.2; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 13:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 26Mar2020, she tested positive for Covid. In the beginning of May2020, she went to get tested for antibodies, she did have them, that she received a report, number was 8.2 and knows that at 1.4 she would be considered to have antibodies so they told her it was good that her number was high, she asked them what it meant and they told her they did not know. Patient had chills, fever of 100.2, bad headache, and muscle aches on 20Jan2021. She took Tylenol to treat her symptoms and they went away, and states they would come back as Tylenol wore off. Her symptoms have completely resolved however she does not have the exact date. Outcome of the events was recovered on Jan2021. Information about lot/batch number has been requested.
69 2021-02-23 headache, lethargy Got dizzy and nauseous not long after the shot. The next day had a one sided headache which lasted 1... Read more
Got dizzy and nauseous not long after the shot. The next day had a one sided headache which lasted 1 1/2 days. Very lethargic which I understand is normal. I was concerned about the one sided headache. Was on the left side of my head. The shot was in left arm. Have not idea if that would make a difference.
69 2021-02-23 headache I previously reported a severe headache following the vaccine, similar to but worse than the headach... Read more
I previously reported a severe headache following the vaccine, similar to but worse than the headache I experienced when I had Covid-19 in March of 2020. I reported that the headache had resolved. However, the headache recurred upon awakening on Tuesday, 02/23/2021 and slowly resolved over several hours and again today, 02/24/2021 I awoke with the headache again. The headache is almost gone but lingers.
69 2021-02-23 chills Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontane... Read more
Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), via an unspecified route of administration in right arm, on 26Jan2021 at 13:15 (01:15 PM), at a single dose, for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a doctor's office or urgent care facility. On 26Jan2021 (reported as 12:15 AM; pending clarification), the patient woke up lightheaded or dizzy, with dry heaves, very warm, and with Charley (reported as Charlie) horses in both legs, then she got the chills. This morning (27Jan2021), the patient felt fine. No treatment was administered for the adverse events. The patient was not tested for COVID-19 post vaccination. The patient recovered from the events on 27Jan2021.
69 2021-02-23 chills, fatigue, fever Over 2 days had severe joint and muscle aches in knees and back. Fatigue. Slight fever and chills.
69 2021-02-23 throat irritation Patient arrived to ED with itchy throat, facial swelling and erythema and tachycardia. Patient was g... Read more
Patient arrived to ED with itchy throat, facial swelling and erythema and tachycardia. Patient was given Benadryl and Pepcid (dose and route unknown), and sent home with a prescription for Methyprednisolone 4 mg dose pack and Ventolin for home use. Patient reports reactions to other medications in the past, having an extensive allergy list.
69 2021-02-23 headache Patient experienced vertigo within 15 minutes of administration of COVID 19 shot. Her blood pressur... Read more
Patient experienced vertigo within 15 minutes of administration of COVID 19 shot. Her blood pressure was 97/73. Five minutes later it was 123/83 and a third reading approximately 15 minutes after the original was 120/81. The patient slowly felt better and was able to walk to find her companion. She had a headache and decided to go home and forgo grocery shopping. The next day she came in person to report experiencing tinnitus and mild headache still. I sat with patient until she felt good enough to walk and then walked with her per her request to help her find her friend. After about an hour of slowly getting better, but not good enough to follow through with her grocery shopping plans. She decided to go home with her friend and rest and come back tomorrow to grocery shop and report back with any further symptoms. She was feeling better enough to grocery shop and she was reminded to please fill out form for reporting purposes.
69 2021-02-23 sweating The itching was located just below the injection site at a spot where the skin was a little red; The... Read more
The itching was located just below the injection site at a spot where the skin was a little red; The itching was located just below the injection site at a spot where the skin was a little red; terrible itching in her left arm; out of balance, her balance was messed up; nervous; Sweaty; Feeling hot; felt like her heart was racing fast; felt dizzy/terrible lightheadedness; Feeling anxious; trouble sleeping; sharp pain in her muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health care professional reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot EL9263) via an unspecified route of administration at arm left on 24Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included drug allergies, IV contrast reaction. The concomitant medication was not reported. It was reported patient got the Pfizer COVID 19 vaccine Sunday 24Jan2021 at 13: 00PM in the left arm. She was scheduled for the second dose of the vaccine 16Feb2021. she got the vaccine and was perfectly fine; she started the wait time of 45 minutes and about 10 minutes into it she got really hot and felt like her heart was racing fast; felt dizzy on 24Jan2021. A nurse practitioner and a doctor came over and sat with her; she got some water and she was okay. They thought it was anxiety related to coming into a crowd, but for the next 36 hours she continued to feel anxious and on edge; she felt like she had too much caffeine. That night she had trouble sleeping; she had sharp pain in her muscles on 24Jan2021, it would be in one of her thighs then the other one. This was about 12 hours after the vaccine. States she took some tylenol and it did help. Adds she just continued to feel anxious and she was sweaty. States she has never has anything like this before. Today she felt perfectly fine; all of her symptoms had resolved. Then today, when she was driving to a routine GYN exam and she experienced a terrible itching on her left arm on 24Jan2021. It was sudden and startled her. The itching was located just below the injection site at a spot where the skin was a little red, feathery red, just below the injection site. Now the itching has stopped but it is still red. she couldn't hardly feel it being injected, she doesn't usually have reactions to vaccines, she never had anything, but she has a few drug allergies, and she was separated out, she was flagged to wait 45 minutes after, instead of the 15. She does have an IV contrast reaction, and some other things, nothing she knew was in the vaccine, she was fine and wasn't worried that she was aware of. She thinks she got too hot, she had on a coat, she was sitting and panning through stuff, reading on her phone, and all of a sudden she had terrible lightheadedness, she never fainted in her life, she is pretty sturdy, she didn't know what to think, she was lightheaded, and it was not vertigo, not like the room was flying, but she was like out of balance, her balance was messed up, and she sat there a minute, she was too hot, she got out of her coat, and it got worse, she could feel her heart racing, and she was talking to herself, she thinks she nervous, she could feel her heart pounding, and was instructed to raise her hand if she had issues, so she raised her hand, a nurse practitioner came over, she raised her hand, and the doctor making rounds came over and he said take off your mask off, she did, that helped somewhat, it was that blasted mask, she couldn't get enough air, he gave her water, she thinks she got too hot and perhaps got nervous and didn't think she was she said she's not been around people, and was suddenly in a huge crowd, everyone was appropriately distanced, it was an extreme presentation, after 5-6 minutes, she was good, it went away, but for 36 hours she didn't feel right, she could feel sometimes her balance wasn't right, she was just not herself, she could do her usual, she lives on a farm, she did usual farm stuff, but was not herself, and in the night, she woke several times, her heart was beating too fast, too much, but she went back to sleep, and she told her son, she said it felt like she had had 4-5 cups of really strong coffee. So the next day she was ok. Absolutely her normal, and then she didn't think anything about it, and was driving to a routine GYN exam, which was canceled last moment due to an emergency, she was driving and suddenly her arm started itching, this was Tuesday, so 48 hours after, not the site, it was distal, underneath it, maybe 2-3 inches under injection site. The site did nothing, she looked that night, no redness, lump, no raised area, no warmth, nothing, but then she had itching, intense itching like poison ivy, and she scratched and thought wait a minute, at her appointment she looked at her arm, this area was 3-4inches under the site, that was red, feathery looking and flat, macular, not raised, no induration, no warmth, no lump, no pain, it was feathery dusty red and the next day it was gone, she did nothing to it, she thought to put hydrocortisone, and looked at it, but it was so faint and wasn't itching. The seriousness was reported as non-serious. The outcome of the events was Feeling hot was recovered on 24Jan2021; Heart rate increased; felt dizzy; Muscle pain; Sweaty was recovered on 25Jan2021; Feeling anxious was recovered on 26Jan2021; Vaccination site rash; Vaccination site erythema recovered in 2021. Vaccination site pruritus was recovering; Difficulty sleeping; Loss of balance, Nervous was unknown.
69 2021-02-23 headache, sweating, chills Violent chills Headache Profuse Sweating Nausea Diarrhea Light-headedness Weakness
69 2021-02-24 fatigue, headache Racing heart for about 8 hours Diarrhea for 3 days Fatigue for 5 days Headache for 5 days Nausea for... Read more
Racing heart for about 8 hours Diarrhea for 3 days Fatigue for 5 days Headache for 5 days Nausea for 3 days Muscle pain for 2 days Joint pain (right knee swollen and painful) for 2 days UTI started 4 days after vaccine
69 2021-02-24 throat pain, pneumonia Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their ... Read more
Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their arms, and chest pressure. EMS evaluated patient on-site. Patient was hypertensive (184/96). 12-lead EKG was NSR, rate of 79 bpm, no ST elevation. FSBG was 137 mg/dL. ETCO2 was 40mmHg with normal square waveform. EMS initiated transport to Hospital Emergency Department. En route, patient became more hypertensive (200/106). In ED, she remained hypertensive and was admitted to inpatient telemetry unit. Patient had 1-night stay to rule out cardiac-related events. Anaphylaxis was ruled out. Discharged with diagnosis of vaccine reaction and chest tightness.
69 2021-02-25 chills, fatigue, headache, fever After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, sl... Read more
After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, slept all day, very weak, couldn?t remember what happen rest of day after booster (2-24) or then next day during sever reaction.(2-25) Day of shot arm hurt for several hours then went away. Day 3 still listless, tired, headache, foggy.
69 2021-02-25 throat irritation After receipt of the Covid-19 vaccination, patient developed a scratchy throat and some tightness. D... Read more
After receipt of the Covid-19 vaccination, patient developed a scratchy throat and some tightness. Diphenhydramine 25 mg/mL and methylprednisolone 125 mg/2mL injections were administered and patient was observed for resolution of symptoms
69 2021-02-25 chills, malaise, sweating Awaken at 7 a.m. feeling sick and had to get to bathroom, sweating profusely, vomited, feeling very... Read more
Awaken at 7 a.m. feeling sick and had to get to bathroom, sweating profusely, vomited, feeling very faint, extreme diarrhea, lasyed almost 2 hrs before being able to get up and shower off and go to bed, chills for 2 days and extremely weak. Afraid to get the 2nd shot!
69 2021-02-25 malaise, headache, fatigue, chills Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep th... Read more
Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021). Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes. Debilitating and confusing. Glad to have received the vaccine in any case (small price to pay).
69 2021-02-25 fatigue, fever, chills Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appe... Read more
Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appetite, which persisted for about 24 hours. Low grade fever present Day 2 after vaccine administered.
69 2021-02-25 chills, headache, fatigue Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sor... Read more
Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sore, body aches and backache all night. I took Bismuth 525mg at 9am, acetaminophen 1000mg at 11am, felt better for a few hours, took acetaminophen 500mg at 6pm.
69 2021-02-25 fatigue Woke up in middle of night with body aches, especially in my legs. Kept me awake for hours. I was ... Read more
Woke up in middle of night with body aches, especially in my legs. Kept me awake for hours. I was exhausted the next day. Aches and exhaustion subsided over 48 hours. After 2nd injection I experienced the same but milder reaction on the tenth day after the injection. However, I have been tired for a longer period of time. About 3 days.
69 2021-02-26 fatigue, fever 02/25/2021 Pfizer-BioNTech COVID-19 Vaccine EUA 02/26/2021 Mild soreness at site of injection 1 da... Read more
02/25/2021 Pfizer-BioNTech COVID-19 Vaccine EUA 02/26/2021 Mild soreness at site of injection 1 day after first shot; soreness only on that day - no longer sore 02/27/2021 Fever 100.2 degrees F and fatigue 2 days after first shot; took (2) 325mg of Tylenol gel caps and rested/slept
69 2021-02-26 fatigue, headache ACHY ARM; JOINT PAIN; HEADACHE; FATIGUE; DIARRHEA
69 2021-02-26 chills, fever, headache, fatigue Chills, fever, body aches, nausea, headache, mind fogginess, light headed, tired, sleepy ( 36 hours)... Read more
Chills, fever, body aches, nausea, headache, mind fogginess, light headed, tired, sleepy ( 36 hours) Body aches, nausea, fogginess, light headed, tiredness (2 weeks)
69 2021-02-26 headache headache next day only one day
69 2021-02-27 cough, throat irritation Coughing, feels like throat is getting tighter, itchy throat, evaluated by EMS-refused transport
69 2021-02-27 malaise MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the ... Read more
MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the first five minutes. I felt totally incapacitated, nauseous, lightheaded, "wiped out", generally drugged and ill. This lasted for about 45 minutes and then subsided. For the rest of the day I had periods off and on of feeling exhausted and tired.
69 2021-02-27 malaise, fatigue On the 14th day post vaccine 2 my right arm was sore near area of injection site. Rest of my arm wa... Read more
On the 14th day post vaccine 2 my right arm was sore near area of injection site. Rest of my arm was fine. I also felt tired and general malaise. Within 12 hours and after taking 2 Alleve tablets I felt much better
69 2021-02-27 fatigue, fever, chills Soar arm, fatigue, low grade fever, chills
69 2021-02-27 nasal congestion Within 10 seconds I began to feel that something was wrong. A full body response of a swirling con... Read more
Within 10 seconds I began to feel that something was wrong. A full body response of a swirling congestion, extreme weakness. very blurry vision and couldn't think straight. I had trouble walking to recovery room, felt nauseous and weak and had a very fast heartrate. I had to stay in private recovery room for 45 min. I was still very ill and nervous at this point. I left with a family member and asked to be driven to the nearby hospital emergency room. For a precaution . We parked across from ER entrance for another 1 hour till I slowly regained strength to 50% normalcy. I went home afterwards and had to go to bed. I was unable to drive my own vehicle home. Day 2, still feel weak, shaky and not normal. I consider this a serious adverse reaction that did not receive medical intervention but will prevent me from getting the second Pfizer shot. After 5 hours post injection I felt 60% normal . Day 2, 70 per cent normal. The vaccination facility was not able to do blood pressure monitoring ( which is a problem for anyone experiencing reactions.) They said their protocol was to call 911/ambulance. My blood pressure was checked by a certified PA with professional equipment at the 3 hour post injection time and the diastolic pressure was still below 50. And heart rate above normal. Still weak and nauseous.
69 2021-02-28 chills, headache Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nau... Read more
Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nausea, lack of appetite. That evening, awoke out of sleep at 3 am with extreme abdominal pain, walked to bathroom and almost passed out, had to lay on the floor for 15 minutes.. After a half our it happened again. No diarrrhea but had 2 soft formed stools (very unusual for me). A lot of nausea, weakness and abdominal pain. Chills for 2 days.
69 2021-02-28 headache, chills, fever Initial onset Nausea, headache progressing to fever, chills, severe pain throughout the body at a... Read more
Initial onset Nausea, headache progressing to fever, chills, severe pain throughout the body at approximately 3:am, lasting approx 30 hrs. Still experiencing moderate headache
69 2021-02-28 headache, sweating, fatigue, malaise muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; pa... Read more
muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; headaches/The headache is above her ear and the pain is "past 10"; She recalled experiencing "swelling around her eyes" and "had some swelling" after the 1st dose of the Pfizer-Biontech COVID19 vaccine/left eye swelling; had some swelling; Dizziness/Lightheadedness; Vomiting; Blurry vision; She said the left arm pain started immediately after receiving the COVID-19; Injection site swelling; she is sweating something fierce under her arms; peeing on herself (running to bathroom more); lady asked her to call her when she got home, and she forgot, saying her mind wasn't there; acid reflux taste in mouth/she tasted the COVID-19 Vaccine shot when it was administered; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at the age vaccination of 69-year-old via an unspecified route of administration in the upper left arm on 19Jan2021 08:00 (also reported as 11Dec2020) at a single dose for covid-19 immunization. Medical history included was hit by a truck a GM and the truck busted her legs up, ongoing RSD (Reflex Sympathetic Dystrophy) pain since 1991 and was prescribed with oxycodone/acetaminophen (PERCOCET), rheumatoid arthritis from 1991 to an unknown date, spinal cord implant is in her spine, and goes from her spine to her waist, and from her waist to both legs, and down to her ankles from 1991 to an unknown date and migraine when she was 12 or 13 years old. There were no concomitant medications. She received the vaccine in a hospital. The patient previously had a flu shot for immunization but was allergic to the flu shot. It was reported that a patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine on 19Jan2021 08:00. On 19Jan2021, the patient reported that she said she had a slight headache, left eye swelling, dizziness, vomiting, blurry eyes, sweating up under her arms, and peeing on herself (running to bathroom more) after receiving the COVID-19 Vaccine. It was reported that the patient had injection site swelling on 19Jan2021. She said she has never had any side effects like what she is experiencing now after getting the COVID-19 Vaccine. She reported that her mild headache turned severe over the weekend, and she had to wrap a towel around the back of her head, so she could lay down. She said the headache pain was a sharp pain at the bottom of the back of her head and neck. She clarified she had migraines when she was 12 or 13 years old, but the headache pain she had now is nothing like the migraines she had then. She further clarified that her severe headache feels like a knife in the back of her head and neck. She said the pain is more severe on the right side of her head than the left. She said right now she has pressure in the front of her head with a slight headache. She additionally clarified that the swelling in her left eye comes and goes and is persisting. She said her left eye didn't swell close, but her granddaughter told her it looks like something is wrong with her left eye. She added that she had dizziness this morning when she was going to work. She said she stumbled when she was walking this morning but drove to work anyway. She said when she got to work, she wasn't feeling well on an unspecified date, so she decided to go back home. She said when she was walking to her car, she stumbled again, and fell against her car. She reported when she first got the COVID-19 Vaccine (19Jan2021), she was driving in a bad way. She said after she got her COVID-19 Vaccine, she picked up an elderly lady she sits with, and the elderly lady told her she wasn't normal. She said the elderly lady told her she was too relaxed while she was driving, like she was in a daze. She said the elderly lady said she was scared for her and herself when she was driving. She said the elderly lady asked her to call her when she got home, and she forgot, saying her mind wasn't there. She mentioned that she had to wait 15 minutes after receiving her COVID-19 Vaccine (19Jan2021), and when she was driving home, she had to pull over and get out of her car to vomit. She said she had an acid reflux taste in mouth before she threw up. She said she threw up a little bit last night when she had a severe headache. Clarified her eyes are constantly blurry now. She said she has to put her glasses on to see but has to turn her head sideways in order to see anything past her blurriness. She said her burry eyes are worse at night. She stated that she was sweating something fierce under her arms, she said she has to take 3 showers a day now to get rid of the sweating and smell under her arms. She said she has never sweated like that before. She reported her left arm is sore too. She said the left arm pain started immediately after receiving the COVID-19 Vaccine (19Jan2021). She said she has swelling too, and has been rubbing her left arm with alcohol, but the left arm soreness is still there. She reported that she tasted the COVID-19 Vaccine shot when it was administered. She has blown off calling her doctor when she first experienced her side effects, but then her headache got worse. She said she so spoke to doctor 30 minutes before calling Pfizer. She said she told her doctor if her headache comes back, she is going to the emergency room when she gets off work after tonight. She stated that she has been experiencing headaches/muscle spasms that have been getting worse. She says they last 15-20 minutes and then it stops. The headache is above her ear and the pain is "past 10". Yesterday night (unspecified date), the headache was so severe that she wanted to go to the ER but was too tired. The patient reported that she was taking ibuprofen (ADVIL) for her slight headache. She said she took the Advil for a couple days and nights, and her headache eased up some with the Advil. She reported that 2 days ago she bought aspirin, caffeine, acetaminophen (EXCEDRIN MIGRAINE). She also reported that she started taking Ibuprofen when her headaches became severe. She said the Ibuprofen eased the headache, but the headache comes back. Reported she took pain medicine prescribed from a doctor way back, and the prescription pain medication doesn't ease her headache pain. She clarified that the medication was dispensed in a pharmacy was oxycodone, acetaminophen (PERCOCET). She called her doctor when she returned home from work this morning, and her doctor told her to call Pfizer to report her side effects. She reported when she went to work this morning, she got lightheaded. She took Percocet and other medications, but it hasn't relieved it. She says it's not a migraine. She recalled experiencing "swelling around her eyes" and "had some swelling" after the first dose of the Pfizer-Biontech COVID19 vaccine on 19Jan2021. She reported on 02Feb2021 that she was calling back today to report that her headaches were worse. She said her headaches are not a migraine, but more like a muscle spasm in the right side of her head, above her ear. She said the pain is between her neck and ear on the right side of her head. She said the headache pain feels like it is as big as a golf ball. She said her headache pain is so severe, the headache pain wakes her up in a cry. She said the headache pain lasts 15-20 minutes, and then eases up slightly. She said the headaches have been happening twice at night, and twice during the daytime. She said the headache pain doesn't last long. She mentioned that she has been doing self-remedies. She said she ate a spoonful of mustard to ease the headache, and the spoonful of mustard did ease her headache. The patient inquired if she should get the second COVID-19 Vaccine if she is continuing to experience headaches after receiving the first COVID-19 Vaccine. The outcome of the events headache, eye swelling, blurry vision, frequency urinary were not recovered, as for the events dizziness, vomiting, vaccination site pain and vaccination site swelling were recovering, while the outcome of the other events was unknown.
69 2021-02-28 headache temp 100.4 HR 105 pulse ox 96 severe upper arm pain (both arms) Hallucinations !! se... Read more
temp 100.4 HR 105 pulse ox 96 severe upper arm pain (both arms) Hallucinations !! severe Headache neuropathy SEVERE Hands were like frozen
69 2021-03-01 headache Woke up (6a) with head ache, body aches, loss of appetite, fuzzy thinking, raised hard area at injec... Read more
Woke up (6a) with head ache, body aches, loss of appetite, fuzzy thinking, raised hard area at injection site - 5in long, 3in wide - slept most of day. Symptoms mostly gone by 3/2 7am, with exception of raised area at injection site and mild fuzzy thinking. Took two tylenol for headache 6p
69 2021-03-01 dehydration she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea ev... Read more
she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea every 15 minutes; required hospitalization on 2/3/2021. Was hospitalized at Hospital. Hospital course was complicated by sepsis, pressors, intubation, GI bleed with ruptured rectum requiring surgery (ostomy). anticipated discharge 3/3/2021.
69 2021-03-02 headache At 2:00am, I had severe pain on the right side of my head...very severe headache, face pain, ear pai... Read more
At 2:00am, I had severe pain on the right side of my head...very severe headache, face pain, ear pain, jaw pain that included my teeth being very sensitive. Tylenol helped ease the pain. It lasted 13 hours. The following night, I had the same exact pains on the left side of my head that lasted 12 hours. For 2 days after, I had a few twinges of pain on the left side of face, mostly below the ear, didn't last more than a couple minutes.
69 2021-03-02 fatigue Extreme fatigue for 3 days Itching all over body Soreness in right arm where the vaccine was recei... Read more
Extreme fatigue for 3 days Itching all over body Soreness in right arm where the vaccine was received Treatment: cortisone cream and tylenol 2 days after vaccine Outcome: Improved and better on 4th day
69 2021-03-02 headache, fatigue Headache on only the left side of the head - treated with Advil 200 mg 4X daily. Lasted 11 days and... Read more
Headache on only the left side of the head - treated with Advil 200 mg 4X daily. Lasted 11 days and was worse late in the day. Fatigue and weakness for 48 hours.
69 2021-03-02 headache I had a headache and my eyes hurt. The back of my eyes were very painful/pressure. this occurred for... Read more
I had a headache and my eyes hurt. The back of my eyes were very painful/pressure. this occurred for several days. It got less severe as time went on. My eyes continue to be tired and I have a slight headache. there is no change in vision that I am aware. I am concerned about receiving the second COVID vaccine.
69 2021-03-02 headache, nasal congestion, chills Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from ... Read more
Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 69-years-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Lot number: EL9262) via an unspecified route of administration on 17Feb2021 13:00 on Left arm at single dose for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included simvastatin, ropinirol [ropinirole] (ROPINIROL [ROPINIROLE]), vitamin d3 (VITAMIN D3). The patient previously took first dose of bnt162b2 (COVID 19 Pfizer Bio Tech) on 27Jan2021 01:15 PM on Left arm for covid-19 immunisation, montelukast and experienced drug hypersensitivity. The patient experienced stuffy nose, chills, strong heartbeat, severe diarrhea, headache all on 18Feb2021 01:15AM with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. The event was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
69 2021-03-02 fatigue became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was ... Read more
became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient (reporter's wife) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 12Feb2021 on right arm at a single dose for COVID-19 immunisation. Medical history included diabetes diagnosed about 30 years prior. Concomitant medications were none. Patient got the 1st dose of bnt162b2 and 4 hours after getting it, her blood sugar went down to 25 (12Feb2021) and she became almost non-responsive. She took a lot of carbohydrates after the shot before she plummeted. Reporter asked if there had been any reports of this and should she take the 2nd shot. Reporter said that he is reporting the side effect of that approximately 4 hours after receiving the shot, which his wife is diabetic, she was tired and then her sugar dropped to 25 before he realized she had an issue. He says she was nearly totally nonresponsive (12Feb2021). He said this was very abnormal and her sugar has never been that low. He said after he realized her sugar dropped to 25, he got some ice cream into her and then some (brand name withheld), then he got her blood sugar which the next reading was 47, then the third reading was mid 90s, so then he took her to the emergency room and they ran tests. He says by then her blood sugar was 250-280, which they thought was good after it had been that low. He says that they did blood tests and did not find anything abnormal, and her blood sugar has been good since then. He said she was not admitted to the hospital, and they went home that night. He said that this had never occurred before, period. Reporter said that everything seems to be normal at this point, though it scared them. He said his wife has not gotten the second dose yet, and they have questioned if she should take the second dose since this happened, and he was wondering if Pfizer may have advice to provide them on getting the second dose for her. The outcome of events was recovered on an unspecified date.
69 2021-03-02 headache eczema flare up, skin red, her left anterior chest was burning and itchy, skin pain; headache; on ea... Read more
eczema flare up, skin red, her left anterior chest was burning and itchy, skin pain; headache; on early Friday evening she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt; This is a spontaneous report from a contactable nurse (patient; retired nurse) via a Pfizer-sponsored program. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6201), via an unspecified route of administration in the right deltoid on 10Feb2021 at 12:35 PM (at age of 69 years old) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a convention center. The patient's medical history included eczema from 24Dec2018 and ongoing, rosacea (developed Rosacea at 65 years old), and the patient also reported that she used to be 5'4" and she lost 2 inches. She said she had a bone density test recently and was told she is 5'2". She said she objected to the measurement of 5'2", so the nurse told her to stand as tall as she can, and then the nurse noted her height as 5'2-1/2". There were no concomitant medications. There were no additional vaccines administered on same date of BNT162B2. The patient had no prior vaccinations within 4 weeks. On 12Feb2021, the patient experienced eczema flare up, skin red, her left anterior chest was burning and itchy, headache, skin pain, and "joint pain that was so bad, she thought she was going to die. She said her wrist, elbows. fingers, hips, knees, every joint down to her ankles, hurt". The patient said she received her first COVID-19 Vaccine on 10Feb2021. She said everything was fine after she received her COVID-19 Vaccine. She didn't even have a mark on her arm where she received the COVID-19 Vaccine. The patient reported that she got the first dose of the COVID-19 vaccine on 10Feb2021 and is due to the second dose on 03Mar2021. Approximately 2 and half days later she got an eczema flare that was quite severe out of the blue since she was having eczema diagnosed since she was 67 (as reported; she is 69 today). She still has some itching and burning and she wondered if this was something that has been reported also for other psoriasis/eczema patients. She was concerned about taking the second dose since she thinks this may be caused by the vaccine as she stated that nothing has changed in her life aside the vaccination. The patient reported she takes tacrolimus for the treatment of her eczema. Also she said that she had some joint pain for a couple of days. She said 2-1/2 days later (Friday, 12Feb2021), out of the blue, she had an eczema flare up. She said she was diagnosed with eczema at 67 years old. She said Friday night (12Feb2021) into Saturday (13Feb2021) her left anterior chest was burning and itchy. She clarified her skin was really red and angry looking, and painful. She said she has not had any pain with her eczema in a long time. She said she took topical ointments and medication for the eczema flare up. She said she was surprised at the intensity of her eczema flare up. She clarified her initial diagnosis for eczema was on her left anterior chest and bra strap area, and arms. She said she has never had eczema on her face or any other part of her body. She said she was totally asymptomatic prior to getting her first COVID-19 Vaccine. She said on early Friday evening (12Feb2021) she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt. She said she had a headache. She said by Sunday (14Feb2021) her joint pain and headache were gone. She said her symptoms went away so quickly. The patient asked if people reported a flare up with psoriasis or eczema after getting the COVID-19 Vaccine and if should she have any concerns about getting the second COVID-19 Vaccine shot on 03Mar2021. The patient her eczema treatment included a combination of oral and topical medications. She clarified she used more of the prescription topical lotion than the over-the-counter oral medications. She received Famotidine 10mg (clarified as Pepcid AC; NDC Number: 11673-031-65, Lot Number: OFE2821, Expiration Date: Feb2022). Her doctor told her she could take up to 20mg of Famotidine if her symptoms were bad. She said on Friday (12Feb2021) and Saturday (13Feb2021) she took 20mg of the Famotidine until she felt her symptoms were under control. The patient also received cetirizine 10 mg (reported as generic Zyrtec; NDC Number: 11673-502-87, Lot Number: 8ME2877A, Expiration Date: Sep2022). The patient reported that she took 20mg of the generic Zyrtec for the itching. She said her doctor told her she can take up to 20mg of the generic Zyrtec, if needed for itching. She said otherwise, she would normally take 10mg generic Zyrtec, as needed. The patient also received Tacrolimus Ointment 0.1% (Protopic Ointment; NDC Number: 0168-0416-30, Lot Number: JZ8459, Expiration Date: Apr2021), applied to affected areas twice a day and Triamcinolone Acetonide Cream, 0.1% (she stated she refers to it as "TAC" Cream; NDC Number: 67877-251-80, Lot Number: Y064, Expiration Date: Oct2022). The patient reported that she uses the "TAC" Cream under her breasts where her bra sits because the "TAC" Cream is less expensive than the Tacrolimus Ointment 0.1%. She said she uses the "TAC" Cream as needed, and the "TAC" Cream keeps her skin hydrated. She said she used the Protopic Ointment (Tacrolimus Ointment 0.1%) on Friday (12Feb2021), and then switched to the "TAC" Cream. The patient has had no itching or pain since early Monday (15Feb2021). Her joint pain and headache treatment included Advil Liquid Gel 200mg (UPC Number: 305730169080, Lot Number: 56264, Expiration Date: Jun2023). She said she took a couple Advil Liquid Gels on Friday (12Feb2021). The patient reported that she switched from Tylenol to Motrin because the Motrin worked well. She clarified she meant Ibuprofen when she said Motrin. She said she calls everything Motrin when she is referring to Ibuprofen. She said she took Tylenol occasionally and never felt the Tylenol worked. She said she hasn't taken Tylenol in a long time. She said Tylenol didn't work as well as the NSAIDs. She did not have the Tylenol NDC, Lot, and Expiration Date. The patient reported that she takes Bufferin Brand Aspirin normally for pain. She said she sees someone who treats her holistically, and that person recommended the Bufferin Aspirin because it was not as damaging to the body. She said since the Bufferin Aspirin takes longer to work, she took the Advil Liquid Gel for faster pain relief. No further details provided. The events eczema flare up, skin burning sensation, skin red, skin pain, joint pain, and headache were reported as serious - medically significant. The patient reported that she felt her symptoms were medically significant because her eczema flare up was so different from what she has ever experienced before. She said nothing had changed in her routine, and she has been in control of her eczema. She said she has had only very minor eczema flare ups. The events did not require a visit to emergency room and to physician office. The outcome of the events eczema flare up and skin red was recovering. The outcome of the events headache and joint pain was recovered on 14Feb2021. The outcome of the events skin burning sensation, skin pain, and itchy skin was recovered on 15Feb2021. The events eczema flare up, skin burning sensation, itchy skin, skin red, skin pain, joint pain, and headache were assessed by the (patient) as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-03-02 headache, chills shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contact... Read more
shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contactable pharmacist. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 vaccination. Medical history included she was previously positive for Covid in Oct2020 to an unspecified date and she received monoclonal antibody treatment (Remdesivir) 3 months prior to her first dose of the vaccine; patient had COPD, oxygen dependent and diabetes from 2016 to an unknown date; and obesity in 2014 to an unknown date. There were no concomitant medications which was reported as patient had not had any other recent vaccinations or started any new medications. Patient received monoclonal antibody treatment 3 months prior to her first dose of the vaccine. Patient probably tested positive and was treated probably the same day she had the positive test (in Oct2020), reporter was sure all of this happened at the hospital, but he doesn't have that information, and the COVID test type was unknown. Reporter's question was related to information about this specific type of patient, having received the monoclonal antibody treatment on 12Oct2020, to an unknown date, which was Remdesivir and also having had COVID then, then having reactions to the dose, would the second dose be necessary, effective, or safe to give to this patient. The patient had her first dose of the Pfizer Covid vaccine 3 weeks ago (estimated as 27Jan2021 by standing order and not prescribed). The patient had general same symptoms listed for side effects of the vaccine that were more severe than others. The patient experienced effects after the first dose of the vaccine as shaking and chills for two days, and headache, diarrhea, and overall body aches (Jan2021). Reporter wanted to know of any studies or research on patients who have been positive for Covid 19 prior to getting the vaccine and treated with monoclonal antibodies and if they do have similar titers to those who have been vaccinated. The reporting pharmacist that the events were serious, and he thought these were medically significant. The patient's symptoms resolved after 72 hours, and reporter did not believe that they did any treatment other than to sleep. The events recovered on an unspecified date in 2021. Information about Lot/ Batch number requested; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tremor, chills, headache, diarrhoea and pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
69 2021-03-02 chills, malaise, headache, fatigue she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing... Read more
she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing in the ears; Hot flashes; Blood pressure went up; Was so dizzy if she moved her eyes she would nearly pass out; Was so dizzy if she moved her eyes she would nearly pass out; Very weak and tired; Very weak and tired; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3247; expiration date: unknown) at vaccination age of 69-year-old via an unspecified route of administration left arm on 28Jan2021 10:00 at a single dose for To keep from getting COVID (covid-19 immunization). The patient medical history was none. The patient's concomitant medications were not reported. The patient stated that she got the first vaccine the other day and within 12 hours (28Jan2021 22:00), she was not feeling well. At 8:30 the next morning (29Jan2021), she was sick for about 8 hours. She was throwing up, had a headache, chills, ringing in the ears, hot flashes, her blood pressure went up, she was unable to get anything down, not even medication [pending clarification]. She was so dizzy if she moved her eyes, she would nearly pass out. She could not move out of the chair for about 6-8 hours. The dizziness was severe and awful. She added only one ear is ringing really bad, the right ear. It is off and on and persisting. Her very weak and tired which was persistent. One hour it may be bad and the next she will be drained. The patient inquired if it is true since she heard the second dose is worse. She also wants to know if she should get the second dose or not. The received treatment for the adverse events was reported as none [pending clarification]. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement) was reported that her blood pressure went up and recovered on 29Jan2021, and weight was 175-180 pounds on an unspecified date. The outcome of the event feeling unwell was unknown, as for the events weakness, tiredness and ringing in ears were not recovered, while the outcome of the other events was recovered on 29Jan2021. Information about Lot/Batch number has been requested.
69 2021-03-02 headache sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness a... Read more
sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness and tingling of lips and tongue; Back began to itch; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 01Feb2021 14:30 at a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, IBS, indigestion, heart burn, colon polys removed, Morton neuroma, torn meniscus left and right, total hyst with bilat oophorectomy and tonsils removed, Shellfish allergy and many medication allergies. Concomitant medication included metoprolol, hydrochlorothiazide, colecalciferol (VIT D3), zinc and pyridoxine hydrochloride (B6). The patient previously took epipen for shellfish allergy. Sat in waiting area 15 minutes as directed. After leaving in car about 10 min. Into ride home she experienced numbness and tingling of lips and tongue on 01Feb2021 15:00. Eventually subsided by 5 pm. Back began to itch, no rash nor hives subsided in about 10 min. Sore arm started about 17:00. Slight headache during night and sore arm continued esp. to lay on left arm impossible. At 8:18 a.m. still sore arm. Cannot raise above my head. No swelling in arm at injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events numbness and tingling of lips and tongue and Back began to itch was recovered on 01Feb2021 while outcome of the other events was not recovered.
69 2021-03-02 fatigue tired; very sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 69-y... Read more
tired; very sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Feb2021 at 14:30 at a single dose, for COVID 19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility where vaccine was administered was reported as "other". On 12Feb2021, the patient had a very sore arm. The patient was tired the next day (13Feb2021). The patient did not receive treatment for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.
69 2021-03-03 chills, headache Had my first vaccine shot on Thursday 2 day later on Saturday evening. I started getting a headach... Read more
Had my first vaccine shot on Thursday 2 day later on Saturday evening. I started getting a headache within an hour very achy body, headache and chills, did not seem to have a fever. continued all day Sunday. Monday body felt better weak and still had a headache. kinda felt a heavy feeling in my lungs.
69 2021-03-03 fever, chills, malaise Muscle pain, joint pain, chills, fever, and pain at the injection site. overall feeling unwell. a li... Read more
Muscle pain, joint pain, chills, fever, and pain at the injection site. overall feeling unwell. a little swollen at the injection site.
69 2021-03-03 fatigue Patient had arm and leg weakness, fatigue, confusion, nausea, body aches that lasted about 48 hours ... Read more
Patient had arm and leg weakness, fatigue, confusion, nausea, body aches that lasted about 48 hours and are improving.
69 2021-03-03 headache She said she has a run of pain that pops up here, and there, and everywhere/pain going down her body... Read more
She said she has a run of pain that pops up here, and there, and everywhere/pain going down her body; Headache; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264; expiry date: unknown) intramuscular in the left arm, on 01Feb2021 between 16:00-16:30, at a single dose, for COVID-19 immunization. Medical History included Right-sided Breast Cancer over 30 years ago. No lymph nodes were involved, so she didn't need chemotherapy or radiation. She had breast reconstruction and right mastectomy performed. She also had 2 hip replacements. Other medical history included nerve disorder and car accident. She has had bad nerves since she was 18 years old. She said she hasn't worked in over 30-something years because she worked so much to raise her kids by herself and send them to college. She said her psychiatrist and a doctor told her she had to stop working. She walks 5 miles every day and has no underlying conditions. Concomitant medications included an unspecified nighttime medication for her nerves and pain medication because she was in a car accident. The patient previously received first dose of BNT162B2 (Lot Number: EK9231) in the left arm, on 11Jan2021 for COVID-19 immunization. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient did not have previous immunization with a Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. The vaccine was administered in a Field. The patient reported that she got her second Pfizer COVID-19 Vaccine dose on 01Feb2021. After she got the second COVID-19 vaccine shot she was okay for a while, then she had a little injection site pain immediately after receiving the COVID-19 vaccine injection. She said the injection site pain was gone, clarifying if she mashes the injection site, the injection site doesn't hurt. She was only able to have shots on her left arm because she had a right mastectomy, so she can't have anything on her right side. On 02Feb2021, the big boom hit, and it has been all day. She has been breathing well and has no temperature. On the same day (02Feb2021) the patient experienced run of pain that pops up here, and there, and everywhere. She had a headache, as well. She was concerned if should take anything for the pain. She does not want to do what is not right. She wanted to do things the way that Pfizer has suggested. She put heat around face, neck, and arms, but now the pain was going down her body. She has been microwaving rice in a bag and using the heated bagged rice to apply heat to her face, neck and arms. She had a physical recently with unknown results, but she had no recent blood work. The events did not require emergency or physician visit. Outcome of the event injection site pain was recovered on 02Feb2021, while for the other events was not recovered.
69 2021-03-03 throat irritation Shortly following injection, the patient complained of chest tightness, itchy throat, and mild eryth... Read more
Shortly following injection, the patient complained of chest tightness, itchy throat, and mild erythema of the skin with pruritus. Serial vital signs were monitored for almost 2 hours and were stable. She was in no acute distress. 8 mg of dexamethasone was administered with improvement of her symptoms.
69 2021-03-03 chills, fever, headache The morning of 3/2 around 4AM - abdominal cramps with nausea (vomited once), achiness, headache, fe... Read more
The morning of 3/2 around 4AM - abdominal cramps with nausea (vomited once), achiness, headache, fever (100.4) and chills. Felt better by the end of the day. Much better the next day.
69 2021-03-03 fever chest pain, subjective fever 9 days after vaccine; 10 days after hospital admit Dx with pericarditis... Read more
chest pain, subjective fever 9 days after vaccine; 10 days after hospital admit Dx with pericarditis + 8mm pericardial effusion
69 2021-03-04 fever, headache, chills Headache, fever, chills, body aches, sore glands under left arm.
69 2021-03-04 headache, fatigue Jittery a few minutes after the injection that went away Tiredness that lasted about 3 days Cold for... Read more
Jittery a few minutes after the injection that went away Tiredness that lasted about 3 days Cold for about 4 days but no fever Headaches that were nagging for about 4 days Diarrhea the first that did not last long Nausea that lasted for about 2 eqyw
69 2021-03-04 chills, malaise Pfizer-BioNTech Covid-19 Vaccine Chills for 6 hours Nausea Feeling unwell
69 2021-03-04 cough, throat pain Severe sore throat; sinus congestion; non-productive cough; This is a spontaneous report from a cont... Read more
Severe sore throat; sinus congestion; non-productive cough; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (Lot number: El9267), via an unspecified route of administration on 10Feb2021 14:15 at single dose in the left arm for COVID-19 immunization. Medical history included osteoarthritis from an unknown date. Concomitant medication included spironolactone. On 11Feb2021 08:00, the patient experienced severe sore throat, sinus congestion and non-productive cough. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
69 2021-03-04 fatigue Woke up the following day (1/29/2021) with extreme vertigo. I have a history of vertigo, last episod... Read more
Woke up the following day (1/29/2021) with extreme vertigo. I have a history of vertigo, last episode 4 or 5 years ago. This episode lasted 5 hours; Exhaustion and slept for 4 hours; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ9264), via an unspecified route of administration on right arm on 28Jan2021 at 15:45 at the age of 69 year old at a single dose for COVID-19 immunisation at the hospital. Medical history included coronary artery disease, vertigo (I have a history of vertigo, last episode 4 or 5 years ago). Allergies to medications, food, or other products was dilantin, streptokinase. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Concomitant medications were not reported. The patient previously took dilantin, streptokinase and experienced allergies. It was reported that patient woke up the following day (29Jan2021, 09:00 AM) with extreme vertigo. This episode lasted 5 hours. Following that, about an hour after she arose, she had exhaustion and slept for 4 hours. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the event vertigo aggravated on 29Jan2021 14:00 and recovered from exhaustion on an unspecified date in Jan2021.
69 2021-03-07 headache Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; Derm... Read more
Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; headache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9265, expiration date: May2021) via unspecified route of administration in the left arm on 16Feb2021 14:00 at single dose for COVID-19 immunization. Medical history included dermatomyositis since 1993 and sinus problems (sinus disorder). Concomitant medications included immunoglobulin human normal (GAMUNEX) and methotrexate 2.5 mg tablets, both for dermatomyositis; and diphenhydramine hydrochloride (BENADRYL 50 mg) IV as premedication. It was reported that every 2 weeks, a nurse comes to her home and gives her a Gamunex 85gram infusion. She clarified she use 4-Gamunex 20gram vials, and 1 Gamunex 5gram vial to make up her Gamunex 85gram infusion. Product information: Gamunex 5gram Vial (uses 1 vial) (NDC Number: 13533-800-20, Lot Number: B36JE00393, Expiration Date: 20Jul2023) and Gamunex 20gram Vial (uses 4 vials) (NDC Number: 13533-800-24, Lot Number: B8GLE00933, Expiration Date: Aug2023). Reported she takes Methotrexate 2.5mg tablets three times a week. She stated she gets pre-medicated every 2 weeks with IV Benadryl prior to her Gamunex 85gram infusion. She provided the IV Benadryl 50mg product vial information as: (NDC Number: 0641-0376-21, Lot Number: 080010, Expiration Date: Aug2022). The patient previously took budesonide 3 mg capsule (taper dose) from 18Nov2020 to 13Feb2021 for microscopic colitis. On 16Feb2021, on the first day after vaccination, patient had a mild headache. The patient woke up on Saturday morning, 20Feb2021, with her facial skin inflamed, bright red, and swollen. She had a rash on her face as she could feel the unevenness of her facial skin when she placed her hand on her face. Patient reported that she called her neurologist to inform her of the adverse reaction, and her neurologist told her to report the reaction to manufacturer. She said what she experienced on Saturday (20Feb2021) was a Dermatomyositis rash flare up, which for her is very rare. She said she normally doesn't have any skin involvement when she has a Dermatomyositis flare. As a treatment, she said she took generic diphenhydramine 25 mg on 20Feb2021 (lot number: Lot Number: P112026, Expiration Date: Sep2020); and took 2 more since then (She said she takes 1 Diphenhydramine 25mg at a time); and her facial redness is down, but she still has a rash, and her face is a little bit swollen. Her facial skin was still elevated a little bit. Her facial swelling has improved quite a bit from Saturday (20Feb2021), stated she does not have any swelling around her eyes now. She said her facial skin is not as red as it was on Saturday. Outcome of the event headache was recovered on unspecified date in Feb2021; while dermatomyositis rash flare up was recovering.
69 2021-03-07 cough, runny nose, fever, throat pain a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fa... Read more
a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fast; Granddaughter had covid virus and passed to caller/she tested positive for COVID 19/she was diagnosed with COVID; she was feeling bad; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date: 30Apr2021), via an unspecified route of administration at the right arm on 24Jan2021 07:15 at a single dose for COVID-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. It was reported that the patient's granddaughter had COVID virus and passed to the patient. The 2nd dose appointment scheduled for 14Feb2021. Patient stated she had the first dose of the Pfizer COVID 19 vaccine on 24Jan2021 at 0715AM in the right arm. After that, she found out she got infected with COVID 19. On 01Feb2021, she tested positive for COVID 19. On 28Jan2021 (also reported as on 28Jan20201 or 29Jan2021), she was feeling bad. Her little granddaughter had COVID virus (was infected at the school) and passed it on to her. Now she has been going to different places checking it out and she went to urgent care because her heart was beating fast on 02Feb2021. She had an electrocardiogram and her lungs were okay on an unspecified date. They told her was eligible to get an infusion but she doesn't know what it is. The urgent care clinic told her she could get the infusion but then she can't get the second dose of the Pfizer COVID 19 vaccine. She wants to ask if this is true. She was being offered a monoclonal antibody infusion. When ask if this is the first time to call, she stated she called once before right after she found out that she had the COVID 19 infection to ask if she could still get the second shot. She did report at that time that she had gotten the first dose and then tested positive for COVID 19 and she previously provided product information including the lot number from her vaccine card. She added that her heart has been going very fast and has been having fever on 02Feb2021 for two or three days. It is not as high today as it was before. She does want to get the second dose. The first dose helped her so much. On 04Feb2021 (reported as yesterday), she was checked at urgent care because of heart concern and a bit of pressure in chest. Patient stated she only had a little cough, sore throat and runny nose, but she hasn't experienced any other symptoms on an unspecified date. The patient's weight was 54.43 kg on 01Feb2021. The outcome of the events "fever" and "her heart was beating fast" was recovering, while the outcome of the other events was unknown. Patient was scheduled to receive her second dose on 14Feb2021.
69 2021-03-07 fatigue checked her BG which was 25; minimally responsive; tiredness; This is a spontaneous report from a co... Read more
checked her BG which was 25; minimally responsive; tiredness; This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN5318), via intramuscular on 12Feb2021 13:00 at single dose in right arm for COVID-19 immunisation. Patient had history of diabetes and had been well controlled for a long time. The patient's concomitant medications were not reported. Shortly after vaccination, patient began complaining of tiredness and told husband she wanted to take a nap. At 16:30 husband found patient minimally responsive and checked her BG (blood glucose) which was 25. Husband gave patient oral forms of sugar and transported to the ER (Emergency Room) where her BG slowly improved to normal range. Outcome of the events was resolved.; Sender's Comments: The patient had history of diabetes. The reported blood glucose decrease and hyporesponsive to stimuli were more likely due to pre-existing diabetes, and less likely causally related to the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-03-09 fatigue her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; ... Read more
her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; thought she pulled a muscle at first; tired; not sleeping well due to the pain; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9267), via an unspecified route of administration on the left arm, second dose on 17Feb2021 at single dose, for COVID-19 vaccination. The patient's medical history was not reported. There were no concomitant medications. Patient took the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine (Lot: EL9264) on 27Jan2021 for COVID-19 vaccination. Patient got her second dose of the Pfizer Covid vaccine 17Feb2021 and experienced side effects such as painful lymph node and breast pain on 18Feb2021. She said that her lymph node in her breast is killing her on the side that she had the vaccine. She clarified that it is very painful and her breast itself is very painful. She said that she did go to the doctor to be sure that is what it was. She further reported that by Thursday night (18Feb2021), it started bothering and her breast started bothering her. She thought she pulled a muscle at first. She said that it has progressed and got worse and that Sunday night she was in agony. She called the doctor Monday for her left breast that hurts. She said that she is taking ibuprofen (ADVIL, Lot: DJ6716, Expiration: Dec2022), taking 3 of them at a time, but it is not really helping. She had no reaction at the injection site. It is not red and you cannot see anything there. She said that is why she is not even sure. She said that there was no pain at all there. She said that there is nothing wrong with her and she does not feel sick, she just hurts. She said that she was tired because she is not sleeping well due to the pain. Patient wants to know what pain medication she could use that will not counteract the vaccine. The outcome of the events was not recovered.
69 2021-03-10 influenza like illness, fever, chills flu-like symptoms; fever; chills; aches/pains; vomiting; abdominal pain -feels like severe case of t... Read more
flu-like symptoms; fever; chills; aches/pains; vomiting; abdominal pain -feels like severe case of the flu; This is a spontaneous report from a contactable nurse reported for self. This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9267) at single dose on 09Feb2021 14:15 in left arm for COVID-19 immunisation. Medical history included severe respiratory infection from Nov2019. Patient thought she might have had COVID, but she was way early, before anyone knew it was in the country, back in Nov2019, she had a severe respiratory infection. Patient stated that her husband was a respiratory therapist, and he fortunately had enough albuterol to choke a horse with, and if it had not been for that and the nebulizer, the caller would have had to go to the hospital. Patient stated that she would wake up in the night and need three or four treatments. Patient stated that before being sick, she had horses and it would take 15-20 minutes to do her routine with the horses, but while she was sick, it took two hours. Patient stated that she would walk out and back, and it was an ordeal, she was tired and short of breath. Patient stated that the doctors called it severe respiratory inflammation, and that was in Nov and Dec2020. Patient stated that she was put on steroids at that time, and she really didn't want to go back to the doctor, so she took some of her husband's steroids, he had some dexamethasone, and she took that and started to feel better. There was no concomitant medication taken. Patient reported flu-like symptoms on 11Feb2021 after her first dose of Pfizer Covid19 vaccine. Symptoms included fever, chills, aches, pains, vomiting, abdominal pain -felt like severe case of the flu on 11Feb2021. Patient would like to know if these were normal adverse events and if they could be worse for her, because she may have had a Covid infection previously. Patient asked what was the efficacy after one dose of the Pfizer-Biontech Covid19 vaccine if she chose not to get the second dose. Patient took her first dose of the Pfizer COVID vaccine on 09Feb2021. Patient stated that two days later, she had side effects and had had them for the last 6 days. Patient stated that if someone picked it, she had it. Patient stated that she had a fever, chills and pain. Patient's fever was running at 102.5 in Feb2021, and she could get it down with paracetamol (TYLENOL) and alcohol. Patient stated that she heard somewhere that the first dose offers 85% protection against the virus, and she was wondering if that was accurate. Caller was scheduled for her next dose on 09Mar2021. Patient was still having aches and pains, and she had vomiting. Patient stated that she was still not over this part of it yet. Patient stated that her side effects started on 11Feb2021 between 4 and 5PM, so more than 48 hours later and they all of a sudden just hit her. Patient stated that the vomiting had stopped, but she did still get some abdominal pain once in a while, but the vomiting stopped about two days ago, but for a while she could not keep food down, and she was just trying to take paracetamol (TYLENOL). For events fever, chills, aches and pain, patient confirmed that these were all still ongoing, but they were getting better. Patient stated that these side effects were a little better yesterday, the caller got up and took a dexamethasone 5 mg and felt better. Patient stated that when she woke up this morning, she was feeling god awful, so she took another dexamethasone, and she was better this afternoon. Patient planned to go to an urgent care today, but she had not been to a doctor yet. Patient stated that they must not have been that serious because she did not go to a doctor, it was like a bad case of the flu, feeling like she got run over with a truck. Patient stated they were serious, but nothing life threatening, caller confirmed all side effects were medically significant. Patient stated that she read that people who had COVID, would react with more severe side effects to the vaccine than people who did not have COVID, and she was wondering if that was correct. The outcome of event vomiting was resolved in Feb2021, outcome of event abdominal pain was unknown. The outcome of rest events was resolving. The patient assessed drug result was related for all the events, Method of assessment: Global Introspection.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "flu-like symptoms and associated fever, chills, aches, pains, vomiting, abdominal pain " and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-03-11 body temperature increased, fever, lethargy, pneumonia Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressi... Read more
Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressively worse - endorsed fever, diarrhea, body aches, trouble breathing, lack of appetite. On 3/2/2021 pt and husband presented to ED. Pt's husband stated that pt had become more and more confused since she received the vaccine and that on 3/2 she could not complete her sentences. Temp 101.6 on arrival, tachycardic in 130s, tachypneic in 120s, but not hypoxic. Patient was given acetaminophen on arrival. IV was inserted and patient was given 1 L intravenous fluid replacement as well as 2 g ceftriaxone for broad-spectrum coverage within 3 hours of arrival. Blood work was drawn that shows no leukocytosis but lactic acidosis to 3.3. There are multiple electrolyte abnormalities, hyponatremia 127, hypokalemia 2.8, creatinine 1.01, ALT 59 AST 53, ALP 136, total bili 1.3, lactic acidosis 3.3, troponin 0.02. Patient was given 40 mEq of oral potassium. Additional L of normal saline was given for total of 2 L normal saline bolus. Chest x-ray shows right basilar pneumonia. Also shows pulmonary nodule of which husband was made aware. LFTs are noted be elevated, so biliary ultrasound was obtained that was negative with limit to body habitus. Husband was updated. Azithromycin was added on. Rapid COVID antigen was negative. 3/3/21: Febrile, SOB overnight. Pt more lethargic, trailing off in the middle of sentences and having difficulties following conversation. Continue sepsis protocol, add vancomycin IV to ceftriaxone and azithromycin. Frequent neuro checks. MRCP. Chest pain-free, serial cardiac enzymes from yesterday to demonstrate nonischemic pattern likely type 2 NSTEMI. 2/2 blood cultures from 3/2 positive for Streptococcus pyogenes (Group A). Vancomycin and azithromycin dc'd. 3/11: Discharged from hospital. Patient admitted for acute hypoxic respiratory failure secondary to right basilar community-acquired pneumonia. Blood culture grew Streptococcus pyogenes, patient was initially treated with ceftriaxone and switched to Ancef . repeat blood culture on 03/04/2021 showed no growth. Patient will complete a total 14 day course of antibiotics with amoxicillin from culture negative date. Patient had right-sided pleural effusion, pulmonary consulted and she underwent thoracentesis x2 culture showed no growth, considered parapneumonic effusion. Patient required 2 L continuous oxygen and deemed stable for discharge. She will follow up with Pulmonary in 3 weeks, outpatient chest CT in 4-6 weeks to be ordered by Pulmonary to assess lung nodule and known thoracic aortic aneurysm. PTOT recommended home discharge with VNA. On discharge patient was a febrile and hemodynamically stable. Remained COVID negative throughout.
69 2021-03-15 headache Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders foll... Read more
Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders followed immediately by fainting, cardio-respiratory arrest that required call 911 for emergency transfer to Hospital. She was intubated in the emergency room treated by the doctors, Cardiologist and Intensive care where she was subjected to hypothermia and other treatments due to the serious neurological damage that she presented. No other organ seemed compromised. Never came out of the coma, passing away on February 26, 2021.
69 2021-03-15 fatigue Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirs... Read more
Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.
69 2021-03-16 chills, headache, lethargy, fever 2/25 woke up at 7:30 a.m. with fever, chills, and severe body aches all day 2/26 same as previous da... Read more
2/25 woke up at 7:30 a.m. with fever, chills, and severe body aches all day 2/26 same as previous day plus lethargy 2/27 woke up at 3:30 a.m. with SEVERE headache and partial loss of vision Went to ER and they diagnosed me with a moderate stroke and mild cognitive issues with right hemisphere vison loss in both eyes.
69 2021-03-18 nasopharyngitis Cold; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 69-ye... Read more
Cold; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number LC3302), via an unspecified route of administration in the left arm on 12Feb2021 at 17:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included diabetes (diagnosed 4-5 years ago). The patient did not have any relevant family medical history. Concomitant medications included echinacea and vitamins, both from an unknown date at an unknown dose for an unknown indication and unspecified medications for diabetes, cholesterol and thyroid, all started prior to the vaccine. The patient previously received a shingles shot (unspecified product) for immunization and experienced injection site soreness. The patient did not receive any other vaccines on same date of the BNT162B2 vaccine and no prior vaccinations within 4 weeks of the vaccine. On 12Feb2021 the patient experienced a cold approximately five hours after the vaccination (reported as 21:30 - 22:00) which was a little worse on Saturday but started to get better and a sore left arm within a few hours of receiving the vaccine (exact time unknown). The events did not require a visit to ER or physician's office and there were no relevant tests performed. The patient stated they have not had a cold in over a year and would like to know if it is a symptom of the vaccine. The patient reported she is taking echinacea liquid and it usually helps within 36 hours and now this is her third day. It has gotten better because she takes echinacea and vitamins as well. The patient stated her left arm was sore, but not bad. She first stated it was 3-4 inches above elbow and later stated it was about 4 inches from shoulder and she did not think it was in the muscle. The patient has an appointment for her second dose in 4 weeks, the patient inquired if there will be an issue with her receiving second dose in 4 weeks instead of 3 weeks. The clinical outcome of the cold and sore left arm was recovering.
69 2021-03-19 fatigue After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shakin... Read more
After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shaking body, had to call 911 , in hospital was diagnose with Atrial Fibrillation, did not have this problem before!! Have to take 4 new medications for the rest of my life!!! I may experience stroke in the future. For a early few days had pain in my left arm. For the next few weeks overall tiredness. strange feelings in my head!!!!
69 2021-03-20 headache, sleepiness, fatigue I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but fe... Read more
I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but feeling like I do I can't work; a slight temp 90.2; had choking episodes; feels like her throat is closing up when she is eating; Food get stuck in my throat; sleeping all day; tired; Headache; Nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 05Mar2021 as single dose for COVID-19 immunisation. Medical history included food allergies and meds allergies, anxiety, depression and blood pressure (abnormal). Concomitant medications included clonazepam (KLONOPIN) taken for anxiety from 2001, buspirone (BUSPIRONE) taken for anxiety from 2001, bupropion hydrochloride taken for depression from 2001, bupropion hcl taken for depression from 2001, and amlodipine besilate taken for blood pressure abnormal from 08Mar2021. On 05Mar2021 19:00, the patient experienced headache, and nausea. On 06Mar2021 19:00, the patient experienced sleeping all day, and was tired. On Day 2, she still had more side effects which wake her up. On 10Mar2021 19:00, the patient experienced had choking episodes, feels like her throat is closing up when she was eating, and food got stuck in her throat. On an unspecified date, the patient was upset and muscle spasms felt like something crawling in her leg and felt "crap"; she got to work but feeling like can't work. The patient reported that she had been having side effects and she was scared to have the shot because of her side effects and have when her body don't recognize it. She was asking when they go away. She has had a headache and nausea, was tired and sleeping all day. She felt like her throat was closing up when she eats. She had a choking episode and her grand daughter had to hit her on her back. She had choking episodes last night and this morning and she was now eating soft foods. She saw her doctor Monday for a regular appointment and she told him what happened. He wanted her to take the second dose but she was afraid to take it. She was afraid she will have worse side effects. Right now, she had nausea and drinking ginger ale. Her doctor called her which she was upset because he haven't seen her at all. Last time was 2019; and she just told him how she feel and want person to person. Patient reported she was not going to take 2nd dose because she do not want to go through anymore side effects. Everyone said that there were no side effects. That's wrong and she was having side-effects from day 1 on Friday night. There was an ingredient which she has allergies to. She told the nurse all meds allergies and food allergies which they told her that nothing in it will cause any side effects. They were wrong. She felt crap and she got to work but feeling like she can't work. Patient refused to take 2nd dose. Patient stated that she do not want to go through what she was going through now. The patient reported that she had a slight temp 90.2 on an unspecified date. The events required a visit to the physician office. The patient had no prior vaccinations (within 4 weeks). Outcome of events choking episodes, nausea, tired, feels like her throat is closing up when she was eating, Food get stuck in my throat was not recovered; sleeping all day was recovered on 07Mar2021; headache was recovered on 10Mar2021; and outcome of the rest of events was unknown.
69 2021-03-20 fatigue, chills passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my hea... Read more
passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head.; Chills; fatigue; nausea; lightheadedness; vertigo; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EM9810) via an unspecified route of administration, administered on the left arm on 26Feb2021 15:15 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate (OS-CAL) and vitamin. The patient previously took BNT162B2 for COVID-19 immunisation (first dose on the left arm at 01:30 PM, lot number: EL 1283); and SHINGRIX vaccine in 2019, codeine and cipro and experienced allergies. On 27Feb2021 03:30 PM, the patient experienced chills, fatigue & then sudden nausea & lightheadedness that resulted in passing out. Unfortunately, the patient fell on a tile floor & hit her head resulting in a 1.5 inch gash in the back of her head. When she went to the ER, it was determined that she now had vertigo (which she never had before) but obviously hard to tell if it was a side effect of the vaccine or from the fall. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events which included CT scan, ekg, chest X-ray, bloodwk (unknown results) and Epley maneuver. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient is not pregnant. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
69 2021-03-24 headache, chills Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and c... Read more
Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and chest pressure. EMS evaluated the patient on-site. The patient was hypertensive (223/180). EMS administered O2 2lpm via nasal cannula. In the ED, the patient reported they felt flushed with a headache. They remained hypertensive (167/89). ED physician admitted patient to inpatient telemetry unit for 1-day. Discharged with diagnosis of chest tightness with associated SOB and palpitations, reproducible on palpitation, troponin negative and EKG with no acute ST-T wave changes, no arrhythmia noted on telemetry, low likelihood of acute coronary syndrome. Patient was instructed to follow-up outpatient for PET stress test and 2D Echo.
69 2021-03-24 headache she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands, sta... Read more
she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes; numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes.; she was getting intermittent headaches; This is a spontaneous report from a contactable Physician reported for a patient. A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 17Feb2021 (Lot Number: EN6201) at age of 69-year-old at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medication(s) included atorvastatin (LIPITOR). The patient previously took first dose of bnt162b2 on 27Jan2021 (Lot number=EL3262) at single dose for COVID-19 immunization. On 20Feb2021, she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands. She reported after few days he started noticing in her bilateral toes. Patient also reported that she was getting intermittent headaches on 20Feb2021. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for 1 day. It was unknown if any treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab SARS-CoV-2 Antigen: negative on 08Mar2021. The outcome of the events was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events paraesthesia, hypoaesthesia and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
69 2021-03-26 fever, chills, cough, fatigue, nasal congestion This is a 70 year old female with paroxysmal atrial fibrillation (anticoagualted on Eliquis), obstru... Read more
This is a 70 year old female with paroxysmal atrial fibrillation (anticoagualted on Eliquis), obstructive sleep apnea (uses CPAP), mitral valve regurgitation, remote tobacco use, hypertension and dyslipidemia who presents to the ED for worsening dyspnea, cough, subjective fever, chills and body aches that have been ongoing for the past several days. The patient indicates that her dyspnea is exacerbated with exertion but she denies chest pain, pleuritic chest pain, leg swelling or calf pain. She mentions that she has received both of her COVID-19 vaccines (Pfizer); the first immunization was on 02/25 followed by her second immunization which took place eight days ago on 03/18. She is not confident that she has had any contact with a known sick or definitive COVID-positive individual recently. Of note, the last documented incidence of testing for COVID-19 was performed on 10/31/2020 after the patient was seen at a Clinic after a exposure for a COVID-positive individual. Testing at that time had resulted negative. To her knowledge, she states that she had, in fact, tested positive for COVID-19 in late fall of 2020, but she was not hospitalized. Yesterday (3/26/2021), she was evaluated at a Pharmacy where she was testing for COVID-19 which has since resulted positive. The patient denies any other acute symptoms of illness. In the ED, the patient was found to have acute respiratory failure with hypoxemia and pneumonia due to SARS-CoV-2 infection. Review of Systems Constitutional: Positive for chills, fatigue and fever. Negative for activity change. Respiratory: Positive for cough and shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for arthralgias and myalgias. Negative for gait problem. Neurological: Negative for syncope. All other systems reviewed and are negative. Vitals Blood pressure 159/79, pulse 65, temperature 36.4 °C (97.5 °F), temperature source Oral, resp. rate 18, height 1.6 m (5' 3"), weight 107 kg, SpO2 98 %. Physical Exam Vitals reviewed. Constitutional: General: She is awake. She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is morbidly obese. She is ill-appearing. She is not toxic-appearing. Interventions: Nasal cannula in place. HENT: Head: Normocephalic and atraumatic. Nose: Congestion present. Mouth/Throat: Mouth: Mucous membranes are dry. Pharynx: Oropharynx is clear. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Decreased breath sounds present. Comments: Diminished breath sounds in all lung fields. Occasional cough. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Behavior: Behavior is cooperative.
69 2021-03-27 headache, chills, influenza like illness mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; jo... Read more
mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
69 2021-03-28 productive cough 03/23/21: Patient presented and was admitted through the ED forof breath that has been present for a... Read more
03/23/21: Patient presented and was admitted through the ED forof breath that has been present for a week, getting worse with productive cough of whitish sputum's but in large amounts throughout the day. PMH significant to COPD. Stated she is been doing her neb treatments without improvement. Has had some constipation and left lower quadrant abdominal pain. on day of admission, chest x-ray showed bibasilar atelectasis with possible pneumonia. Rapid Covid 19 came back positive. Her D-dimer was elevated. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
69 2021-03-28 fatigue Received Pfizer-BioNTech vaccine on 1/26/21 and 2/16/21. Presented to ED with fatigue and shortness ... Read more
Received Pfizer-BioNTech vaccine on 1/26/21 and 2/16/21. Presented to ED with fatigue and shortness of breath. Was found to have a GI bleed and was tested for COVID-19 prior to admission to hospital for treatment. Was admitted from 3/22/21 to 3/27/21 and reported only mild COVID-19 symptoms during stay.
69 2021-03-29 sweating Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or w... Read more
Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or walk, altered vision (white picasso slides),
69 2021-03-31 headache, chills, fever paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chil... Read more
paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chills; fell; This is a spontaneous report from a contactable Physician. A 69-year-old female no pregnant patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 10:30 AM at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included prior spinal cord trauma with rt foot drop. No Known allergies. No COVID prior vaccination. The patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 69-year-old, via an unspecified route of administration at single dose for COVID-19 immunisation. The patient started the next day on 11Mar2021 02:00 PM, after the 2nd shot with headache, fever 101.2 and weakness. Took Tylenol and went to have a nap. She woke up with still fever and chills, when she tried to get up she fell. She was currently in the hospital, paralyzed with no sensation at all in her legs till her waist. AEs resulted in Emergency room/department or urgent care, Hospitalization for 5 days, disability or permanent damage. Lab data included Nasal Swab on 11Mar2021: Negative. No COVID tested post vaccination. Solumedrol 1000mg IV were received. Treatments were received for the events. Outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-04-01 pneumonia, cough, chills, headache 3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal... Read more
3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal swab was positive for SARS-CoV-2 and she was diagnosed with COVID-19. 3/17 She presented to ED w/ cough, HA, weakness and decreased appetite. Room air pulse ox was 88%. She was found to have bilateral infiltrates on CRS and was hyponatremic. She was admitted to the hospital on oxygen and decadron.. On 3/18 she was weaned off oxygen. She was discharged to home on 3/19 to complete a 10 day course of decadron.
69 2021-04-01 headache, fatigue Left side of neck, site of injection, elbow, joints and muscles down left side; Left side headache c... Read more
Left side of neck, site of injection, elbow, joints and muscles down left side; Left side headache continuing to spread; Left jaw, cheek, nasal area swelling; left eye sagging/ occasional eye droop; Tired; general aches mostly on left side; wobbly; hives; skin itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534 and expiration date not provided) via an unspecified route of administration, administered in left arm on 15Mar2021 15:45 as a single dose for COVID-19 immunisation. Medical history included hypertension, chronic dry eye, Bells Palsy, arthritis, allergies to penicillin, injected iodine and food sensitivities. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan, multivitamin and ciclosporin (CEQUA). On 15Mar2021 15: 45, the patient experienced left side headache continuing to spread. Left jaw, cheek, nasal area swelling and left eye sagging (previous site of Bells Palsy attack)-Left side of neck, site of injection, elbow, joints and muscles down left side. She was tired and progressed to general aches mostly on left side and was somewhat "wobbly" on 15Mar2021 15:45. She later had hives and skin itching on an unspecified date in Mar2021 which lasted a couple of days. Tiredness continues and swelling in face and occasional eye droop at 4 days out. No treatment was given in response to the events. The outcome of the event fatigue was not recovered while the outcome of the rest of the events was recovered on an unspecified date in Mar2021. The patient has not been tested for COVID-19 post vaccination.
69 2021-04-01 fatigue Lung disorder; Post procedural complication; Shaking; Feeling down; Tiredness; This is a solicited n... Read more
Lung disorder; Post procedural complication; Shaking; Feeling down; Tiredness; This is a solicited non-interventional study report from the marketing program received from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in Jan2021 (Batch/Lot number was not reported) as single dose, second dose intramuscular on 15Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; adalimumab (HUMIRA, Solution for injection in pre-filled syringe), subcutaneous from 2015 (Batch/Lot number was not reported) to 2020, at 40 mg (40 mg,1 IN 2- 2), subcutaneous from 2020 (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 IN 2- 2) for Moderate To Severe Rheumatoid Arthritis and lupus. Medical history included hatal hernia, blood clots on legs were not worsened with Humira, non smoker, abstains from alcohol, allergy to latex manifested by rash, allergy to Sulfa drugs manifested by upset stomach. Concomitant medications included lisinopril (LISINOPRIL) taken for blood pressure, start and stop date were not reported; ezetimibe (ZETIA) taken for blood cholesterol, start and stop date were not reported; folic acid (FOLIC ACID) taken for rheumatoid arthritis, start and stop date were not reported; esomeprazole magnesium (NEXIUM) taken for hiatal hernia, start and stop date were not reported; apixaban (ELIQUIS) taken for blood clots on legs, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; proline (PROLIN) taken for an unspecified indication, start and stop date were not reported; tramadol (TRAMADOL) taken for pain, start and stop date were not reported. The patient experienced lung disorder on an unspecified date with outcome of not recovered, post procedural complication on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of not recovered, tiredness in Jan2021 with outcome of recovered in Jan2021, feeling down on an unspecified date with outcome of unknown. Clinical course: Solicited report by a consumer of a 69 year old female with events of small tumor on thyroid, blood clot on both legs, coughing and shortness of breath and non-serious lungs issue caused by methotrexate, after surgery shaking a bit, tired and cloudy weather caused to feel down a bit with HUMIRA 40MG/0.4ML (ADALIMUMAB). The patient had a relevant medical history of hiatal hernia and blood clots on both legs. On unknown dates, the patient experienced lungs issue caused by methotrexate, after surgery shaking a bit and cloudy weather caused to feel down a bit. In 2016, the patient experienced blood clot on both legs. In Sep2020, the patient experienced small tumor on thyroid. On 01Sep2020, the patient experienced coughing and shortness of breath. In Jan2021, the patient experienced tired. In Jan2021, the tired resolved. Methotrexate and covid-19 vaccine were also considered suspect. In Sep2020, the patient was admitted in hospital for cough, shortness of breath and was treated with unknown oral and intravenous antibiotics. While she was in the hospital, it was discovered that she had a tumor on her thyroid. She had stayed a week in hospital. She also had a lung issue. It was discovered lots of scar tissue on lungs and according to the physician it might be from patient's lupus, rheumatoid arthritis or methotrexate. The physician said that it was caused by the methotrexate not the Humira. Methotrexate was stopped for her. Patient denied to have pulmonary fibrosis and said that according to her doctor she did not have it and she did not know her diagnosis as it was not discussed with her doctors. For problems in lungs, patient was on oxygen. Patient was off of Humira for three weeks. She had surgery on thyroid biopsy. After the surgery she was shaking a bit. She thought it was because of the anesthesia but she was fine shortly after. The biopsy results were inconclusive which looked like it was not cancerous but physician could not really tell patient if it was or it was not. On unknown date in 2020, patient had restarted Humira again. On 04Dec2020, patient had thyroid tumor removed and was on oxygen until 11Jan2021. Sometimes the cloudy weather caused patient to feel down a bit. She did not have any paper work for the blood test. It was unknown if patient was enrolled in a covid-19 vaccine trial. In Jan2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer. On 15Feb2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer. The reported events except for coughing were serious as medically significant. The patient underwent lab tests and procedures which included biopsy: inconclusive in Oct2020 and in Dec2020, biopsy of tumor: inconclusive in Sep2020, blood test: unknown results in 2020, computerised tomogram of chest: unknown results in Oct2020, COVID-19 TEST: negative in 2020 and in 2020. The action taken in response to the events for bnt162b2 was not applicable, for methotrexate sodium was permanently withdrawn on an unspecified date, for adalimumab was dose not changed. The reporter's assessment of the causal relationship of the events with the suspect products bnt162b2 and methotrexate sodium was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities. Information on Lot/Batch number has been requested.; Sender's Comments: Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of events, cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-04-01 sweating face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneou... Read more
face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration, administered in right arm on 05Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and stroke. The patient is not pregnant. It was not sure if there were known allergies. The patient did not receive other vaccine within 4 weeks prior to the COVID vaccine but took other medications in two weeks (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medication. On 05Mar2021, within one hour of the vaccine, the patient experienced face numbing burning, sweating, fast heart beat and numbness on face that will not go away all day every day since the vaccine. The events resulted in Emergency room/department or urgent care and eventually hospitalization on an unspecified date for 2 days. It was unknown if treatment for the events were given. The patient underwent COVID test post vaccination via Blood test/ CBC differential on 05Mar2021 and was negative. The outcome of the events was recovered with sequelae on an unspecified date in Mar2021. Information about lot/batch number has been requested.
69 2021-04-05 fatigue, headache On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain. A ... Read more
On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain. A few days later I noticed I had extreme shortness of breath. I went to see my PCP on or about 3/31. He listened to my heart and discovered a rapid heartbeat. He then took an EKG. He wanted to put me on lifetime meds immediately. I was in shock because I truly believe this is a reaction to the COVID vaccine. I have never had arrhythmia. In fact, I had a wellness visit with the Dr. about 3 months previously and all was good. I have been seeing him for four years since I moved. He does not think my new diagnosis is related to a vaccine reaction, but I find it highly suspect that 4 other women in my large circle of friends also have AFIB after 2nd shot. I spent Easter in the ER and they pumped Metoprolol in my bloodstream. I did not stay in the hospital that night. I went to see the Dr. on Monday morning on 4/4. He prescribed Metroprolol 25 mg and Xarelto 20 mg IMMEDIATELY. I picked up the meds and started this regimen. In speaking with other women, I believe this terrible diagnosis is a direct result as a reaction from the vaccine.
69 2021-04-06 fatigue If she laid her arm on it, it was painful on the left side where she got the injection between her l... Read more
If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla; couldn't go back to sleep; very tired; weak; She had the lump and that was in the lymph node; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; irregular heart beats; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; baseball sized lump. It was hard/where she got the injection; It looked like it was connected to the breast because it was so huge.; Fever blister; heart beating so out of rhythm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 at 12:20 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing coeliac disease; hypothyroidism, is diabetic and has irregular heartbeat from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for hypothyroidism; hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN/HCTZ MYLAN) taken for blood pressure measurement; metformin, glipizide and pioglitazone hcl taken for diabetes mellitus; acetylsalicylic acid (ASPIRIN 81) taken for thrombosis; metoprolol taken for heart rate irregular, cyanocobalamin (VIT B12) taken for an unspecified indication, all from an unspecified start date and ongoing; famotidine, rosuvastatin, vitamin d2, vitamin d3 and potassium, all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6198, NDC: 59267-1000-1, expiry: unknown) on 27Feb2021 at 1:40PM for COVID-19 immunisation. The patient got her last shot on 18Mar2021. The first day was fine. She woke up the next morning at three or four with her heart beating so out of rhythm it was crazy. It took almost the whole day. She called her cardiologist and couldn't get into them and she didn't want to go to the ER. She didn't have a way to prove any of that. She also got a baseball sized lump. It was hard. If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla. It extended underneath the axilla. She wasn't able to get in with the cardiologist because she waited to late in the day. She couldn't get off the couch that day because her heart was so out of rhythm. She was very tired and wanted to just lay down. She hates going to the hospital. She doesn't want to go to the hospital. She has a history of irregular heartbeats. She should have gone in and had an EKG. She has pictures of the lump if those are needed. HCP information: Her doctor had said if she had anything like any abnormal heart beats to come in and get an EKG. She also had a fever blister on 22Mar2021 that she hasn't had in years and was asking if this influences her immune system. She had the lump and that was in the lymph node and now a fever blister on the top lip. Heart beating so out of rhythm: it lasted all that day. She took a nap after she talked to the doctor's office and slept for several hours. When she woke up it was kind of back in rhythm, but it was going in and out. It wasn't as frequent as it was prior to nap. Prior to the nap it was almost continuous. It slowed down a lot on the 19Mar2021 and was gone by 20Mar2021. Outcome of event: She has PAC's and PVC's anyway. That is why she follows up with the cardiologist. They haven't been so out of rhythm as they were after the vaccine. She couldn't go back to sleep. She still has them occasionally and that is kind of normal for her. She was weak and tired. Baseball sized lump: it has gone down. She took pictures to show her friends who were all getting the shots. It is gone now. It might have started on 20Mar2021. She woke up with the lump on Saturday. She has recovered completely. Her daughter said she needed to get it checked out. Reporter had heard of a lump on the breast was a side effect. It looked like it was connected to the breast because it was so huge. Seriousness criteria: It was irritating because it was so big. It was painful if she put her arm down. It was like her breast were engorged. Causality: Heart beating so out of rhythm: she hasn't had it that bad, so she thinks it was. She had it a long time ago, maybe once before, but it never lasted that long or took her down like that. She is not the only one that has had the complaint of irregular heartbeats. She put on social media what she experienced and how weak she got. Several friends said that happened to them as well. She doesn't know their history. Reporter declined to do a report on her friends. That was another reason she didn't go to the hospital. She thought it was a normal side effect. She thinks she found on her paperwork about the lump in the lymph nodes. The patient underwent lab tests and procedures which included electrocardiogram: unknown results and heart rate: irregular on an unspecified date. The outcome of the event fever blister was not recovered, while of the rest was unknown. Reporter seriousness for heart beating so out of rhythm was reported as disabling.; Sender's Comments: Based on the information currently available and the plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events 'heart beating so out of rhythm ', 'baseball sized lump (where she got the injection/It looked like it was connected to the breast because it was so huge)' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
69 2021-04-06 fever Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report... Read more
Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN9581), via an unspecified route of administration in left arm on 02Mar2021 13:30 (at the age of 69-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's first dose of bnt162b2 (lot not reported) (at the age of 68-years-old) in left arm on 01Feb2021 at 14:00 for Covid 19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have other vaccines within 4 weeks prior to the COVID vaccine. Medical history included mild syncope episodes and pacemaker. The patient had no allergies to medications, food, or other products. Concomitant medications included alondranate, calcium, metropolol and an unspecified multi vitamin. The patient experienced arm soreness in the first 24 hours on 02Mar2021. Mild syncope and low grade fever 20 days after dose 2 (on 21Mar2021 at 13:00). The treatment received for the adverse events was paracetamol (TYLENOL). The outcome of all events was recovered on 03Mar2021 for pain in extremity and in Mar2021 for the rest of the events.
69 2021-04-07 fatigue, malaise a week after both COVID-19 vaccinations (Pfizer) patient had sudden onset of shortness of breath and... Read more
a week after both COVID-19 vaccinations (Pfizer) patient had sudden onset of shortness of breath and chest pain with extreme fatigue and malaise. This happened for 3 days after 1st vaccine. Recovered 90%. Same symptoms onset a week after 2nd COVID-19 vaccine but symptoms were a little worse and did not resolve
69 2021-04-07 chills vision loss; Severe Migraine over her right eye; blurriness, can't see out of right eye, very blurry... Read more
vision loss; Severe Migraine over her right eye; blurriness, can't see out of right eye, very blurry was reported as worsened; Body Aches; Nausea; Chills; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), batch lot number unknown, on 22Mar2021 at 09:15 (at the age of 69-year old) at single dose for COVID-19 Immunization. Relevant medical history was not reported. The patient received first dose of the same vaccine on 01Mar2021, on the left arm. Caller states that she has usually gotten sick with the flu shot. Concomitant medications were not reported. On 22Mar2021 the patient experienced chills. On 23Mar2021 the patient experienced nausea, body aches and severe migraine over her right eye and vision loss. She stated that when she covered her good eye she could not see the couch due to blurriness in the right eye. The patient was treated with ibuprofen and acetaminophen (TYLENOL), used hot packs, cold packs and a hot water bottle.The patient recovered from chills on 23Mar2021, she was recovering from nausea and body aches but was not recovered from severe migraine over right eye and can't see out of right eye, very blurry (reported as worsened). Information about lot/batch number has been requested.
69 2021-04-09 headache, fatigue she got really tired; She started having problems on 12Mar2021 & went to the Emergency Room on 24Mar... Read more
she got really tired; She started having problems on 12Mar2021 & went to the Emergency Room on 24Mar2021 & was diagnosed with Bells Palsy; he had a severe headache, as well. She said the headache felt like major pressure and pain on the right side of her head, specifically behind her right ear; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Lot number - EN6206, expiry date- not reported) via an unspecified route of administration in right arm on 10Mar2021 at 12:00 PM as single dose for COVID-19 immunization. Medical history included ongoing type 1 diabetes mellitus Stated she has had Type 1 Diabetes Mellitus for about 50 years, sleep apnoea syndrome for years, thyroid disorder and influenza immunisation. Concomitant medication(s) included trazodone. On 12mar2021, the patient started having problems on 12mar2021 & went to the emergency room on 24mar2021 & was diagnosed with bells palsy and he had a severe headache. She said the headache felt like major pressure and pain on the right side of her head, specifically behind her right ear and she got really tired. The outcome of bells palsy is recovering whereas the outcome of headache and tired is recovered and unknown respectively. The patient underwent lab tests and procedures which included computerised tomogram: normal on 24Mar2021 and computerised tomogram head: normal on 24Mar2021. Therapeutic measures were taken with events. The patient took Prednisone and Venlafaxine for Bell's palsy and myalgia pain and trazodone taken for sleep apnoea syndrome. The other medication used for events were Valtrex, Tylenol and Acetaminophen.
69 2021-04-11 fatigue Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like sy... Read more
Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like symptoms, including fatigue, muscular weakness and tremor, confusion, memory problems, lack of concentration. Abandonment of previously routine household and personal tasks. Inattentiveness to personal hygiene. Inability to perform previously routine tasks. Notable lack of concern about lost physical and mental capabilities.
69 2021-04-13 headache Weakness in left leg, blod clots in lungs, severe headaches continuing I went to emergency on Febru... Read more
Weakness in left leg, blod clots in lungs, severe headaches continuing I went to emergency on February 23, 2021 where I treated for weakness in left leg and was admitted to hospital where I received treatments for a double pulmonary embolism on March 1.
69 2021-04-14 chills, headache Severe headache, long lasting cramps over entire night in both legs, and chills
69 2021-04-16 headache, sweating, chills She was so dizzy; Stool black; Explosive bowel movements; hot and cold chills; hot and cold chills; ... Read more
She was so dizzy; Stool black; Explosive bowel movements; hot and cold chills; hot and cold chills; drenched in sweat; walker to back up in the bed; Nauseous; Sore arm; Slight headache; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: EM9810), on the morning of 16Feb2021 09:58 (at the age of 69-years-old) intramuscularly in the right arm as a single dose for COVID-19 immunization. The patient's medical history included knee replacement surgery years ago, dyslipidemia, depression, insomnia, constipation problems; she was taking clopidogrel (PLAVIX) because she had a hole in her heart last year (2020). This was fixed (on an unspecified date), and she was only taking PLAVIX once a day for one year, which will be until Jul2021; the patient called it a hole in her heart because that was what her heart specialist told her. Concomitant medications included: clopidogrel bisulfate (PLAVIX) taken for hole in heart from Aug2020 and ongoing, venlafaxine hydrochloride (EFEXOR), simvastatin (ZOCOR), and temazepam. The patient had an allergic reaction to sulfamethoxazole/ trimethoprim (BACTRIM), and she was also allergic to hydrocodone bitartrate/ paracetamol (VICODIN). On 17Feb2021, had a slight headache and a sore arm. On Friday, 19Feb2021, she woke up very nauseous to her stomach; no treatment received. The patient had hot and cold chills really bad. Her head was just drenched in sweat and this occurred all day long. When she did go to use the restroom and had a bowel movement, her stool was black. It was like black tar around 10:00 or 11pm, it was bad. Every time she sat down to use the bathroom, the sweating would get more intense and every time she would get up and use the restroom, she had to use a walker. Then, she used the walker to back up in the bed (19Feb2021), and she seemed to be okay. It seemed like the sweats would go away and she would get the cold chills. The patient just put a heating pad on her stomach, and this occurred all day long until Saturday morning. She mentions she does have constipation problems, but this was explosive. She couldn't get to the restroom a few times. She had several explosive bowel movements on 19Feb2021 10:00. Her husband brought the garbage pail in the bedroom and she did use plastic on the bedding. By 11:30-12pm on Saturday (20Feb2021), it completely stopped, but she was still sweating. She was so dizzy. It would hit her so bad and her head as wringing wet. However, when she would get back in the bed and lay down flat, the sweating would go away, and she would start to get the cold chills. The patient explained the sweating/hot and cold chills went away by yesterday afternoon (unspecified date). She was able to walk back and forth to the restroom with no problems. She verified all of her symptoms have improved. On 02Apr2021, the patient reported she received the second dose of the vaccine on 09Mar2021. The patient reported that sore arm and chills were important medical events, for which no treatment was received. Treatment received for diarrhea included "limgen". The outcome of explosive bowel movements and stool black was recovered on 20Feb2021, and the other events recovered on an unspecified date. Follow-up (02Apr2021): New information received from a contactable consumer includes: medical history, product data, concomitant medications, and event details. Case upgraded to serious. Follow-up attempts are completed. No further information is expected.
69 2021-04-17 headache, chills heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; ... Read more
heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; This is a spontaneous report from a . A contactable consumer (reported for herself). The 69-year-old female patient received first dose BNT162B2 (Pfizer Covid-19 Vaccine Lot Number: EP7534 and Expiry date: Unknown) via an unspecified route of administration on left arm at a SINGLE DOSE on 18Mar2021, for COVID-19 immunization. Medical history and concomitant medication were not reported. On 18Mar2021 (the night she received the Pfizer Covid Vaccine, dose one) she woke with her heart pounding (heart palpitations), slight headache, muscle aches, and left arm hurt. When she went to the doctor, on an unspecified date in Mar2021, they took her blood pressure, and it was very high. It was stated that she went to primary care physician and then she was sent to a Cardiologist. On 26Mar2021, she underwent electrocardiogram and echocardiogram, results were normal for both the investigations. On the same day 26Mar2021, she also had Holter monitor test done (electrocardiogram ambulatory) however the results were pending. On 20Mar2021, the patient recovered from the events of slight headache, muscle aches, left arm hurt and high blood pressure, the outcome of the event of pounding heart was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
69 2021-04-26 nasopharyngitis, productive cough shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a ... Read more
shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a cold; felt hot; she couldn't sleep,; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737, expiration date: 30Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left deltoid on 08Apr2021 10:30 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia. Patient stated she has had fibromyalgia for about 20 years. She said she had a fibromyalgia flare up with increased back pain, and had a Toradol 60mg intramuscular injection in her left hip on Tuesday, 06Apr2021. Concomitant medication included ketorolac tromethamine (TORADOL) for fibromyalgia from 06Apr2021. It was reported she had her first COVID-19 vaccine injection on Thursday 08Apr2021 at 10:30AM. She said that night (08Apr2021) she couldn't sleep and woke up at 3:00AM (09Apr2021) with shortness of breath, productive cough, and throat congestion. She said she had so much throat congestion, she could hardly talk. She clarified she felt like she woke up with a cold. She said she still had the productive cough, but her other symptoms went away by 8:30AM-9:00AM on 09Apr2021. She said she hadn't had a cold in 4 years. She said she read something on the internet that suggested her symptoms may be due to having the COVID-19 virus prior to getting the COVID-19 Vaccine. She said if she had the COVID-19 virus prior to getting her first COVID-19 Vaccine, she was totally asymptomatic. She said she wanted to know what she should do. Patient further reported she felt her shortness of breath was medically significant because she was mouth breathing. She clarified she felt hot during that time, and took her temperature, which was 97 degrees. She said she thought the fact she was hot was medically significant because she thought she may have a bad respiratory infection or something. The patient was not brought to the emergency room or physician's office in response to the events. The patient recovered from shortness of breath, felt hot, throat congestion on 09Apr2021; recovering from productive cough, and unknown outcome for the remaining events. The events were assessed as related with bnt162b2.
69 2021-04-28 fatigue it'll feel like little flutters; Heart palpitations; Shortness of breath; Didn't feel like normal se... Read more
it'll feel like little flutters; Heart palpitations; Shortness of breath; Didn't feel like normal self; Site pain; Chest pressure; Difficulty sleeping because of heart rate; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP7534), via an unspecified route of administration administered in right arm on 29Mar2021 at 09:20 (at the age of 69-year-old) at hospital facility as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within four weeks. The patient had no relevant medical history. Patient reported that she has people in the family that have had heart problems. Concomitant medication included unspecified vitamins. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EM9990 or EM9890) administered in the right arm on 08Mar2021 (at the age of 69-year-old) for COVID-19 immunisation and had a little fast heart rate but not constant, little fatigue and site pain. The patient previously took steroid injections 2 years ago (2019) and had heart palpitations before. The patient further mentioned that normally after the steroids wear off, the heart palpitations go away. The patient reported that she did not have any problems following the first dose of the COVID-19 vaccine. Caller reported that she had a little fatigue and site pain for just a couple of days but that everything was fine. Patient reported that she felt a little heart palpitations for maybe a day or two and then it was gone following the first dose of the COVID-19 vaccine. After she got the second dose of the COVID-19 vaccine on 29Mar2021, she noticed the heart palpitations again and a little shortness of breath. The heart palpitations and shortness of breath were nothing that she felt that she had to run to the emergency room or anything over. The patient reported that now it was getting difficult for her to sleep sometimes at night because of the heart rate. The patient also reported that she was trying to figure out that from this length of time between her second dose of the COVID-19 vaccine on 29Mar2021 and time of call on 14Apr2021, could the heart palpitations be a side effect from the COVID-19 vaccine. Patient also mentioned that when she experienced heart palpitations before, a whole work up was ordered and she was referred to cardiology and that nothing was found during the work up after previous experience with heart palpitations. The patient also mentioned that she has been fine, that she has been able to work and walk and that she gets her 10,000 steps every day. After getting the COVID-19 vaccine, she was tired and didn't feel like her normal self. The patient also reported that when the time had arrived to get the second dose of the COVID-19 vaccine, about a week before, she may have had a little fast heart rate but not constant. It was also reported that following her second dose of the COVID-19 vaccine on 29Mar2021, the fatigue started about the same time as it did following the first dose, on the second day post-vaccine on 30Mar2021. Patient reported that she was kind of tired and just taking a nap during the day. The fatigue was still ongoing. It was also reported that patient was starting to feel better other than the heart palpitations. The patient reported that yesterday, 13Apr2021, she felt great and could do her normal routine, other than feeling chest pains and palpitations. The heart palpitations are not constant, but are more regular during the day than she was used to. The heart palpitations were really bad last night, 13Apr2021, and that she had difficulty sleeping because of heart rate (couldn't hardly sleep at all). The patient's doctor was scheduling her for an echocardiogram. The patient's doctor did an electrocardiogram (EKG) on her on 08Apr2021 and there was nothing there (normal). The patient's doctor was scheduling her for a stress echocardiogram. The patient also mentioned that after returning from the physician's office, her husband went back and looked at the symptoms from the COVID-19 vaccine information sheet. The patient reported that her husband thought that she needed to call to eliminate everything, that they are trying to figure out why the patient was experiencing the heart palpitations. The patient also mentioned that 2 days ago she got on her treadmill to walk and went for 30 minutes. Patient reported that it normally takes her 5 minutes to recuperate, but that time it took her 20 minutes before she felt comfortable after her walk. The patient also reported that the site pain was nothing serious following both doses of the COVID-19 vaccine. The site pain began shortly after receiving the vaccine and went away after the second day following both vaccines. The shortness of breath probably started about 5 days after she got the second dose of the COVID-19 vaccine. The shortness of breath wasn't enough that she felt that she needed to run to the emergency room. It just felt like when she would breathe, especially at night as she normally breathes with her mouth closed at night, the patient felt like she had to open her mouth to breathe because she can still feel the pressure in chest. The patient was still experiencing the heart palpitations. The heart palpitations are a little worse because they happen so often. Patient reported that initially, she would have a few heart palpitations and then go for hours with none. Patient reported that now, she was feeling the heart palpitations quite a bit. Patient reported that it feels kind of like a little pressure in her chest and then it'll feel like little flutters. The patient further reported that she experiences a little pressure in her chest when she experiences the heart palpitations. At times, the chest pressure would go away, but she always feels the chest pressure there now. The chest pressure has gotten worse over the past couple of weeks and that she was thinking that it would go away like the first one did. Patient reported that she went to the doctor last week and was given an EKG. Patient reported that the EKG was fine and that her physician was scheduling other tests to make sure it's nothing with her heart. The patient didn't think that the heart palpitations and shortness of breath were from the COVID-19 vaccine, but that her husband looked at the vaccine information paper after her doctor's appointment and said she should call Pfizer. The patient had not yet recovered from heart palpitations, shortness of breath, fatigue, and chest pressure while outcome of the rest of the events was unknown.
70 2021-01-04 headache Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was ... Read more
Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself. A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: "don't know if it E or and F, looks like EH9899") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension. The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling "like I had COVID." She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.
70 2021-01-04 head discomfort, headache, sleepiness, fatigue Pfizer-BioNTec COVID-19 vaccine Patient received vaccine on 12/22/2020 and on 12/29/20, she emailed ... Read more
Pfizer-BioNTec COVID-19 vaccine Patient received vaccine on 12/22/2020 and on 12/29/20, she emailed us saying that she was feeling sleepy, tired, was having night sweats, and had headaches. Her head felt like someone had put a heavy stone on it. She can still function.
70 2021-01-04 fatigue, headache, fever, sweating, influenza like illness, malaise, chills sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had ... Read more
sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had the virus or bad flu; could not hardly open eyes/eyes were very heavy; could not hardly open eyes/eyes were very heavy; chills; tiredness; headache; muscle pain; weakness; Joint pain; Fever; Injection site swelling and redness; Injection site swelling and redness; injection site pain; Nausea; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left upper arm, on 21Dec2020 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (lasted 3 weeks), high blood pressure (family history in mother and father), lumpectomy, breast cancer, radiation treatment, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, fibroid tumors, fibroid tumors surgery, thyroid problem, bone density problem, and lower lobe left of lung piece cut out (not cancer). The patient previously received chemotherapy (MANUFACTURER UNKNOWN) for breast cancer, pethidine hydrochloride (DEMEROL) for post fibroid tumors surgery and experienced swollen hands and arms, influenza vaccine (MANUFACTURER UNKNOWN) in 2020 (usually gets swelling/red arm), and oxycodone hydrochloride;paracetamol (PERCOCET) and experienced feeling sick. Concomitant medications included unspecified medications for high blood pressure, thyroid problem, and bone density problem and unspecified nasal spray, water pill, and vitamins. The patient experienced could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, injection site swelling and redness, injection site pain, nausea, sweats, and feeling of unwellness like she had the virus or bad flu on 22Dec2020. The clinical course was reported as follows: The patient felt fine the day when injection was given, but the next day, it was like she had COVID again. She had COVID 3 months ago and it lasted for 3 weeks. It was the same symptoms she had. She could not open her eyes hardly. They were very heavy. The patient had the chills, temperature, sweats, and injection site pain (the next day). There was also swelling and redness that remained for 6 days. The patient reported that if she still puts her hand on it now, there is some sensitivity. She also had tiredness and headache. The patient reported that she only had each of these symptoms for 24 hours (as reported) and the headache was gradually improved. The patient had muscle pain and weakness. She laid down and all she could do was sleep for 24 hours. The patient had nausea for 4 days. She did not have swollen lymph nodes. The patient underwent lab tests and procedures which included blood pressure: 120/80 on an unspecified date and bone density: unknown results on an unspecified date. The clinical outcome of could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, sweats, and feeling of unwellness like she had the virus or bad flu was recovered on an unspecified date, nausea was recovered on 26Dec2020, and injection site swelling and redness and injection site pain was recovered on 28Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
70 2021-01-05 fever, chills, fatigue fatigue; 102 fever; chills; This is a spontaneous report from a contactable consumer. A 70-year-old ... Read more
fatigue; 102 fever; chills; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in left arm on 29Dec2020 15:00 at a single dose for covid-19 immunization. Administration was done in a Nursing Home/Senior Living Facility. The patient's medical history was not reported. Concomitant medication included trazodone and methimazole. On 01Jan2021 at 03:00, the patient experienced fatigue, 102 fever and chills. The outcome of the events was not recovered. There was no treatment received for the events. The consumer considered the events as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19.
70 2021-01-05 headache, throat irritation severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash ... Read more
severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash to face and throat,
70 2021-01-06 malaise, fever, chills, fatigue, headache Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pf... Read more
Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pfizer-BioNTech. Administered by her place of work. Vaccine was administered in left arm. Had same symptoms as when she had COVID in 10/2020 these symptoms lasted for 12 hours. Started the following day 24 hours after vaccine administration. Symptoms include injection site redness for 6 days, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and overall feeling of un wellness lasting 12 hours. First symptoms was eyelid heaviness and weakness. No treatment, symptoms resolved on their own. Second vaccine due 1/11/2021. Was covid positive 10/2020- no appetite, aches, chills, sweating, weakness, heavy eyelids, fatigue, ongoing for 3 weeks. Has had difficulty in the past to flu vaccines with local injection site reactions. 09/2020 flu vaccine no symptoms. Has had pneumonia vaccine with no difficulties. Has not received shines vaccine yet.
70 2021-01-07 headache, body temperature increased Had my 2nd vaccine on Jan 7, 2021. My arm was sore when I went to bed that night. I woke at 5:15 AM ... Read more
Had my 2nd vaccine on Jan 7, 2021. My arm was sore when I went to bed that night. I woke at 5:15 AM feeling achy. I took my temp and it was 98.8F which is a temp for me since I run low, around 96.9F I got ready for work at the hospital and went in. around 0830 my temp was 99.5 and I was more achy and sore. I called Employee Health and they said to continue to monitor my temp and call back if it passes 100. Then around 3PM , my temp was 101.5F I remain very achy and have some occasional ear pain and a mild headache,
70 2021-01-07 headache She verbalize she develop headache, nausea, dizziness. She was evaluated onsite by Rescue and relea... Read more
She verbalize she develop headache, nausea, dizziness. She was evaluated onsite by Rescue and released home feeling better at 10:25 am.
70 2021-01-08 fever Fever Narrative:
70 2021-01-08 headache, fatigue Headache extreme fatigue, did not work yesterday; Narrative:
70 2021-01-11 fatigue, headache, sweating Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and... Read more
Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and felt jittery, lightheaded, sweating, numbness/tingling in both hands, feeling strange
70 2021-01-11 chills, fever, headache fever of 105F; chills; severe headache; arm pain; This is a spontaneous report from a Pfizer-sponsor... Read more
fever of 105F; chills; severe headache; arm pain; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable healthcare professional (HCP). A 70 year-old female patient (pregnancy information not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 18Dec2020 (at the age of 70 years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to receiving the vaccination it was not reported if the patient had been tested for COVID-10. It was also not known if she received any other vaccinations in 4 weeks or other medications in past 2 weeks. On 18Dec2020, the patient received the first dose of the COVID-19 vaccine and had arm pain that lasted for a few hours at that time. Seventeen days post first vaccination (approximately 04Jan2021), she developed a fever of 105F, chills and severe headache which have now resolved. She wanted to know if she should get the second vaccine in series given her side effects. it was not reported if the patient was hospitalized or treated for the events.The clinical outcome of the events of arm pain, fever of 105F, chills and severe headache was recovered on an unspecified date. It was not reported if the patient was tested for COVID-19 after receiving the vaccination. Information about batch/lot number has been requested.
70 2021-01-11 sweating sweating, lightheaded, tingling/numbness in both hands, high blood pressure, swollen arm/redness
70 2021-01-11 headache very bad headache; feels terrible/feeling bad; she was sick; This is a spontaneous report from a con... Read more
very bad headache; feels terrible/feeling bad; she was sick; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL4238, Expiration date: 30Apr2021), via an unspecified route of administration at site of right arm at 14:00 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing high cholesterol for several years. Concomitant medication included rosuvastatin calcium (CRESTOR) for cholesterol (had taken it for several years). The patient had a bad headache and feels terrible at 6 am on 07Jan2021, she wanted to know if she could take something for the headache. She got up at 6 am and feeling bad on 07Jan2021, she left for work and came home, and she was sick. Her feeling terrible started sometime during the night. She was feeling fine on 06Jan2021. These events were identified as non-serious by reporter. Vaccination Facility Type was in public health department. Vaccine was not administered at military facility. No history of all previous immunization with the Pfizer vaccine considered as suspect. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. No adverse events required a visit to emergency room. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. The outcome of events 'headache' was not recovered; of rest events was unknown.
70 2021-01-14 respiratory tract congestion, cough At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, a... Read more
At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, and chest. VS:100.2, 113, 20,108/59, 84% room air. applied nasal cannula at 4-L, telephoned Physician orders 6mg Decadron one time order, a second set of Vitals , reads 99.3, 110, 20, 106/60, 90% on 4-L N/C. On coming shift advised. At approximately 2:00am on 1/15/2021, resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately 2:30am PRN cough syrup and breathing tx. Resident's condition began to worsen with breathing tx. This LPN updated at 0248 doctor on resident's condition. Doctor gave permission for resident to go to hospital. At 4:19am the Er called to say resident passed away.
70 2021-01-14 fever fever, aches. called in sick to work.
70 2021-01-16 headache Severe headaches, nausea, vomiting, swelling of face and throat
70 2021-01-17 sweating, headache dizzy, wobbling side to side, severe headache, sweating, vomiting.
70 2021-01-18 headache Developed a severe headache followed about 24 hours later by nausea
70 2021-01-18 fatigue Fatigue, chest pressure. Followed up with PCP EKG showed ST elevation; scheduled stress echo next we... Read more
Fatigue, chest pressure. Followed up with PCP EKG showed ST elevation; scheduled stress echo next week.
70 2021-01-18 headache, chills, fatigue, fever Received first COVID vaccine at 4:30 on Monday, 1/11; Morning of 1/12 had expected symptoms of heada... Read more
Received first COVID vaccine at 4:30 on Monday, 1/11; Morning of 1/12 had expected symptoms of headache, chills, tiredness; Evening of 1/12 at about 6:30 pm diarrhea approximately 5 - 6 times and febrile about 99.3 (normal temp is around 96.8 - 97.4); Night of 1/12 about 11:00 pm got very dizzy, bad nausea, headache worse and this continued until about 3:30 - 4:30 am on 1/13; day of 1/13 chills and headache continued throughout day, lessening by early evening; Evening of 1/13, about 8:00 pm developed rash on head, face, neck and chest and took a Benadryl, which knocked me out and given no sleep the night before, I slept until noon of Thursday and returned to what I consider full health by 4:00 pm, about 72 hours after receiving the shot.
70 2021-01-19 malaise After 45 minutes post vaccine my tongue felt fat. I did not have trouble breathing or swallowing. Af... Read more
After 45 minutes post vaccine my tongue felt fat. I did not have trouble breathing or swallowing. After approximately 1hour the tongue no longer felt fat but started feeling rough and a red spot about 1/4 inch has developed on the top/side of my tongue. I have not consulted treatment at this time.
70 2021-01-20 malaise, headache Headache with burning lips burning and stinging in right side of face with slight swelling. Pulsati... Read more
Headache with burning lips burning and stinging in right side of face with slight swelling. Pulsating area below lip on right side of face. Pulsation visable when looking at face. On the first day, Jan 19, 21. Nausea,dizzyness and off balance,headache. Second day 1/22/21 just general unwell feeling all day with headache.
70 2021-01-20 headache, body temperature increased I had COVID-19 in December for more than 3 weeks. I felt like I felt during that time.. I was weak... Read more
I had COVID-19 in December for more than 3 weeks. I felt like I felt during that time.. I was weak. I hurt everywhere. I had a temperature. of 101-102 degrees. My normal temperature is 97.6. I had a severe headache. My vision was impaired. I would go from freezing to being very hot.
70 2021-01-20 chills, headache Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomi... Read more
Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomit; Both hands went numb with pins and needles; Both hands went numb with pins and needles; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration from 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included known allergies: latex, high blood pressure, hypothyroidism, and mitral valve prolapse. There were no concomitant medications. At 11am, 2 hours after receiving the first COVID19 vaccine, my reactions occurred simultaneously. The patient experienced Strong chills, Bad headache, Abdominal Very painful abdominal cramping, Heavy salivating, Nausea, Both hands went numb with pins and needles, the patient felt like she was either going to vomit or have a bowel movement, ultimately it was the latter. This is when both her hands went numb. These reactions lasted 15-20 minutes and then dissipated with the exception of a lingering less painful headache through Friday and Saturday. The patient did not receive treatment for the events. The outcome of the events was recovered.
70 2021-01-20 throat irritation Swelling face, itchy, slightly closed feeling in throat. Benadryl 50 mg given, went to ED.
70 2021-01-20 fatigue Trouble sleeping, body aches, stomach upset, extreme fatigue. All symptoms cleared up by 1/21/20... Read more
Trouble sleeping, body aches, stomach upset, extreme fatigue. All symptoms cleared up by 1/21/2021.
70 2021-01-20 headache tightness of shoulders and neck; tightness of shoulders and neck; started having severe nausea in th... Read more
tightness of shoulders and neck; tightness of shoulders and neck; started having severe nausea in the last hour; Has a slight headache; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 08:00 in left arm at single dose for covid-19 immunization. Medical history included ongoing diabetes (she had it for 20 years), ongoing asthma (she had it for 25 years), ongoing cirrhosis of the liver non alcoholi diagnosed two years ago, ongoing hypertension diagnosed in the last three months, ongoing fatty liver diagnosed two years ago. There were no concomitant medications. Patient had Covid vaccine this morning at 8 am (12Jan2021) that was fine after 15 minutes, but patient started having severe nausea in the last hour and was unresolved by her nausea medicine. Patient had a slight headache. Patient stated that the headache which was mild, tightness of shoulders and neck started at 13:30. Patient stated that she took acetaminophen 1000 units and used a heating pad for the shoulder. Outcome of nausea was not recovered, and outcome of events were recovered on 12Jan2021. Information on the lot/batch number has been requested.
70 2021-01-21 headache, chills, body temperature increased Headache and achy feeling that night. Next day headache progressively got worse, queasy went to ful... Read more
Headache and achy feeling that night. Next day headache progressively got worse, queasy went to full nausea, trouble eating anything because of the nausea, aches in every joint, temperature reached 100.2 before going to bed (I almost never hit 97.2), chills. Thursday, still have milder headache, still achy all over, arms just feel heavy, temp still at 98.9. Friday, still have headache and loss of appetite, but much better
70 2021-01-21 chills, headache, fever, fatigue Headache, Fever, Chills, Nausea, Body Aches. Restless. Worst symptoms lasted 24 hours. The next 24 h... Read more
Headache, Fever, Chills, Nausea, Body Aches. Restless. Worst symptoms lasted 24 hours. The next 24 hours was lingering headache, fatigue, but improved from day before.
70 2021-01-21 headache Patient experienced mild headache, improved without intervention No other complaints, vital signs no... Read more
Patient experienced mild headache, improved without intervention No other complaints, vital signs not taken at the time
70 2021-01-21 headache Patient experienced mild headache, resolved quickly (less than 30 mins) without intervention, evalua... Read more
Patient experienced mild headache, resolved quickly (less than 30 mins) without intervention, evaluated by Nurse practitioner
70 2021-01-23 headache, fatigue Bad Headache, Fatigue for a duration of 28 hours
70 2021-01-24 chills She feels a little bit of chills and weakness; She feels a little bit of chills and weakness; Cold a... Read more
She feels a little bit of chills and weakness; She feels a little bit of chills and weakness; Cold and hot feeling on [her] body; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced delayed symptoms after the first injection of the COVID-19 vaccine, received on 06Jan2021. Patient explained feeling fine the first three days post injection, and later on 09Jan2021 having "chills" and weakness. She then described her experience as "cold and hot feeling on her body". She felt good, her breathing was okay. Her oxygen and everything was okay. Outcome of the events was unknown. Information on the lot/batch number has been requested.
70 2021-01-25 cough, chills, fever Cough fever chills then on 1/22/2021 coughs fever chills severe abdominal pain nausea vomiting indi... Read more
Cough fever chills then on 1/22/2021 coughs fever chills severe abdominal pain nausea vomiting indigestion
70 2021-01-25 fever, chills, headache, malaise Patient self-reporting through the hospital's electronic reporting system. In her own words, "Recei... Read more
Patient self-reporting through the hospital's electronic reporting system. In her own words, "Received 2nd Pfizer COVID-19 Vaccine. Beginning 17 hours later, I had extreme weakness, headache, chills and fever. I had to take off Friday, January 22, 2021, from work because of not feeling well. I still am not feeling well".
70 2021-01-26 headache, chills, fatigue Headache, chills, fatigue
70 2021-01-26 fatigue, headache extreme fatigue, headache, loss of appetite lasted 24 hours
70 2021-01-28 headache, body temperature increased Body ache; diarrhea; Headache; Elevated temperature; This is a spontaneous report from a contactable... Read more
Body ache; diarrhea; Headache; Elevated temperature; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3302), via an unspecified route of administration in the left arm, on 14Jan2021 at 09:00 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included heart disease and high blood pressure (HBP). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included acetylsalicylic acid, clopidogrel (PLAVIX PLUS). Other concomitant medications included unspecified blood pressure medication, unspecified cholesterol medication, and unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced body ache, diarrhea, headache, and elevated temperature on 15Jan2021 at 14:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included body temperature: elevated on 15Jan2021. The patient did not receive any treatment for the events. The clinical outcome of body ache, diarrhea, headache, and elevated temperature was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
70 2021-01-28 fatigue, lethargy Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontan... Read more
Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient receive first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EK9231), via an unspecified route of administration injection once to left upper arm in inner muscle on 10Jan2021 at single dose for covid-19 immunization. The patient had no relevant medical history and concomitant medications. The patient experienced fatigue/ extremely tired in Jan2021, dizziness/ very dizzy on 14Jan2021 18:30, pain on her arms in Jan2021. Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Sunday and has been experiencing some side effects. These side effects include Dizziness, Extreme fatigue and Pain on her arms. She wants to know if this was normal. She got her shot, later clarified as COVID shot, at hospital last Sunday, so about a week ago, and had no side effects up until yesterday, she was extremely tired, and last night about 6:30PM, she was very dizzy until 5 this morning. She works at a hospital; they gave the shot. Outcome of extremely tired: stated she was in bed, was just very lethargic, being very dizzy went away at 5 this morning, states she has recovered completely but she is just a little off. When asked for vaccination card, states she shouldn't have gotten up that fast, this was really weird that it would wait 5 days. This was her first shot, thinks the dose was on the paper, it was 0.3mg, she was not sure. The outcome of events for dizziness/ very dizzy was resolved on 15Jan2021, for fatigue/ extremely tired was resolving, for other events was unknown.
70 2021-01-28 chills, headache Headache and chills
70 2021-01-28 fatigue feeling tired; This is a spontaneous report from a contactable consumer via a Pfizer sales represent... Read more
feeling tired; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. An 8-decade-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 for COVID-19 immunization. On an unspecified date, the patient experienced feeling tired after receiving the second vaccination which did not last long, maybe half a day. It was reported that the patient was not tired after the first vaccination. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
70 2021-01-29 headache, malaise Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone ... Read more
Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone floor and was unconscious. Taken to ER in ambulance. All diagnostics were normal and after blood pressure returned to normal and getting 4 staples in my scalp I was released. Since coming home I have been very ill with weakness, vertigo, nausea, and headache.
70 2021-01-29 chills, fever Day 1 & 2 irritability and depression Day 3 nausea, fever, chills & diarrhea - really felt bad, bu... Read more
Day 1 & 2 irritability and depression Day 3 nausea, fever, chills & diarrhea - really felt bad, but no vomiting. Was able to eat. Day 4 (today) fever, chills and diarrhea - feel a little better than yesterday. Still able to eat ok. I have not contacted my healthcare provider about these symptoms because it is the weekend. If I still have symptoms on Monday, I will call him. In the meantime I?m taking Tylenol for the fever and drinking water to stay hydrated.
70 2021-01-29 throat irritation Lips started tingling, Lips tingled more and roof of the mouth got tingling, ears itchy, throat itch... Read more
Lips started tingling, Lips tingled more and roof of the mouth got tingling, ears itchy, throat itchy, throat felt slightly closed up Took a Claritin and sat for an hour til the symptoms cleared up. Took Benydril when I got home because the tingling started coming back in my lips. Symptoms were gone in another couple of hours.
70 2021-01-29 throat irritation Patient describes having lips tingling, and feeling hot as well as her upper gums occurring about 7-... Read more
Patient describes having lips tingling, and feeling hot as well as her upper gums occurring about 7-8 minutes after the vaccine administration. Patient denies any difficulty in breathing. Patient is drinking some juice- describes the feeling of her throat feeling scratchy. 1035 VS- HR-52, 96% RA, 132/76. At 1048 patient reports that she feels better and the symptoms have gone away and she feels the same as she did when she came into have her vaccine. Patient will continue to wait a full 30 minutes after beginning of being checked out. 1100- patient reports again feeling the same as she did when she walked in and feels ok to leave.
70 2021-01-30 fatigue, fever At around 09:30 am I was feverish, tired and sick at my stomach and vomited twice.
70 2021-01-31 fever, chills, sweating Fever/temperature about 101 degrees; Sweating; chills; This is a spontaneous report from a contactab... Read more
Fever/temperature about 101 degrees; Sweating; chills; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) on 14Jan2021 at single dose in Left Upper Arm for COVID-19 immunisation. Medical history was none. There were no concomitant medications. She had vaccine on Thursday 14Jan2021 and last night or probably Saturday into Sunday she experienced the chills and fever. She was fine now, but all day on 17Jan2021 she experienced a fever of a temperature about 101 degrees, she was now back to normal. She had chills and sweating. She took Tylenol. She had her first dose on 14Jan2021. Then the symptoms started either late Saturday on the 16Jan2021 or going into Sunday on 17Jan2021. All she knows was Sunday was when she woke up with the chills and the fever. She was sweating, which started after taking the Tylenol. She took the Tylenol Sunday morning. She stated that no symptoms are ongoing at the moment. She felt good right now, there are No symptoms at the moment. She has had No positive Test for Covid before the vaccine. She had a negative Antibody Test, but it was About a good 6 months ago in 2020. She has had No issues with vaccines in the past. The outcome was recovering.
70 2021-01-31 headache, malaise Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling ... Read more
Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling well. Pt complained of lightheaded/dizziness, headache, and weakness and transferred to wheelchair. Vital signs monitored (148/77, spo2 100%). Patient stated this is above her baseline and not usual. Patient began to complain of chest pressure and was transferred to EMS stretcher to continue to monitor and transferred to hospital.
70 2021-02-01 fatigue, headache Muscle aches; joint aches; exhausted feeling; slight headache; This is a spontaneous report from a n... Read more
Muscle aches; joint aches; exhausted feeling; slight headache; This is a spontaneous report from a non-contactable consumer (patient herself). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the right arm on 18Jan2021 at 12:00 PM at a single dose for COVID-19 immunization, given by the retirement home and administered at the nursing home/senior living facility. Relevant medical history included pre-diabetic, obesity, high lipids, and allergies to some psychiatric (psych) medications (meds) only. Concomitant medications included risperidone, calcium levomefolate (DEPLIN), travoprost (TRAVATAN), ibuprofen, and famotidine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Jan2021 at 15:30 (also reported as "beginning around 3 pm"), the patient experienced muscle aches, joint aches, exhausted feeling, and slight headache mainly in the afternoon. The reporter assessed all the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
70 2021-02-03 cough, throat pain, fatigue, runny nose Cough-sore throat,runny nose-fatigue
70 2021-02-03 chills, fever, headache Fever 100, pain at injection site, body aches, chills, headache
70 2021-02-03 fever I have daily fever of 99-100,6 especially in the morning, tired. I would like to know if will be saf... Read more
I have daily fever of 99-100,6 especially in the morning, tired. I would like to know if will be safe to take the second dose.
70 2021-02-03 chills, fever Intestine discomfort, multiple bowel movements (no diarrhea), chills, feverish (but no fever), muscl... Read more
Intestine discomfort, multiple bowel movements (no diarrhea), chills, feverish (but no fever), muscle aches. I'm reporting this 24 hours after getting the 2nd Pfizer shot. Reaction started overnight. Don't know at this time how long this will last. Have not called doctor. Taking Tylenol.
70 2021-02-03 chills bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl a... Read more
bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything; threw up; very dizzy/dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, unknown expiration), via injection in right arm on 13Jan2021 at a single dose for COVID-19 prevention. Medical history included ongoing vertigo (in car accident a little over 5 years ago, that affected a big nerve in left temple, and so every once in a while she will get vertigo so bad that she falls over), ongoing GERD (from a hiatal hernia; diagnosed many years ago), ongoing high blood pressure diagnosed about 15 years ago, ongoing bad cholesterol diagnosed 10 to 15 years ago, ongoing heart burn, ongoing hiatus hernia, and car accident a little over 5 years ago. Concomitant medications included ongoing omeprazole sodium (OMEPRAZOLE) for GERD, heart burn, and hiatal hernia (started this product at least 10 years ago; takes the product as needed if she is having heart burn or is going to eat spicy food); ongoing vitamin D3 for vitamin supplementation (started product about 8 months ago, because her doctor told her too, she guesses her vitamin was low); ongoing metoprolol for high blood pressure and to prevent stroke (started product at least 15 years ago; her BP could be regular but it could shoot up when she is upset, so she takes this to prevent stroke); ongoing hydrochlorothiazide for blood pressure (started product at least 5 years ago); pravastatin for bad cholesterol (started the product at least 4 or 5 or more years ago); and ongoing acetylsalicylic acid (BABY ASPIRIN) to prevent stroke (has been taking this product forever, at least for 10 years). The patient reported that she received the first COVID shot on 13Jan2021. She was okay on the 13th, 14th, and 15th. However, on the 16th (16Jan2021), she woke up and threw up once and was very dizzy for three days. She mentioned that she had like vertigo, she couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything. She had vertigo (16Jan2021). She was that way on Saturday and Sunday. On Monday, the patient's son took her to acupuncturist for her dizziness and was able to get up fine and walked away. After the acupuncture, she felt fine, like she was all better. On 19Jan2021 (reported as yesterday), she was fine. She woke up at midnight and had terrible acid reflux for 3 hours even though she had hardly eaten. She does take omeprazole for heart burn, and she had taken omeprazole earlier in the day, but it was just coming up, that acid and burning. She drank milk to coat the stomach and it went away at 03:00 AM. She had very bad chills/terrible chills (20Jan2021) and her teeth were chattering, she couldn't even talk, and couldn't control the chills. She is fine now. She clarified that she got vertigo from a car crash years ago and haven't had it in almost a year. Chills are not ongoing at this time, she has not had any for about 4 hours now, and she is hoping she is recovered completely, but it may be too soon to tell. She did not receive other vaccines on the same day as the COVID vaccine. The patient is wondering if all this could be from the vaccine. The patient wanted to know if it is safe to take the second shot. She was scheduled to receive the second dose on 03Feb2021. The patient recovered from the events threw up on 16Jan2021; unable to walk and vertigo on 18Jan2021; dizziness on 19Jan2021; and terrible acid reflux on 20Jan2021. While unknown outcome for chills.
70 2021-02-04 fatigue, sweating, chills, headache, fever Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakn... Read more
Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakness, diarrhea . Had Weakness for two more days.
70 2021-02-04 fatigue, chills, cough, fever I had shortness of breath, cough, chills and fever, along with body aches. I was coughing a white m... Read more
I had shortness of breath, cough, chills and fever, along with body aches. I was coughing a white milky sputum. There was no indication of lung infection. Extreme fatigue.
70 2021-02-04 runny nose, throat irritation, sneezing I was sneezing non stop; injection site was sore; can't taste; nose started running/ my nose was lik... Read more
I was sneezing non stop; injection site was sore; can't taste; nose started running/ my nose was like a faucet, non stop, clear; asked if it can it give her COVID since her symptoms were similar to COVID; asked if it can it give her COVID since her symptoms were similar to COVID; I felt scratchy in my throat; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248 and expiration date not provided), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took shingles vaccine for immunization and experienced shingles. The patient reported that she got her first dose of the COVID vaccine on 13Jan2021. On 17Jan2021 night and into 18Jan2021, she felt scratchy in her throat. She did not think anything of it because the temperature change was not unusual in the patient's state and so she thought it was that. But, on 19Jan2021, her throat was more scratchy and then her nose started running more. By Wednesday, 20Jan2021, her nose was like a faucet, non stop, clear and her throat was definitely scratchy and she was sneezing non stop. Her injection site was sore too which she totally expected. Now, her physician has given her a steroid pack and did a rapid test, which was negative but the following day they are doing a PCR test, so, she will see. She also stated that she can still smell but can't taste and that started last night, 20Jan2021. She asked if they were seeing these. And if this was listed or being reported and if she should get the second dose. She went on to state that "I would not call my symptoms severe and I'm having my PCR tomorrow, but when they mention to me that they have had other patients with this experience". She also asked if it can it give her COVID since her symptoms were similar to COVID and other people are having symptoms. She also reported that 4 months ago, she got her first shingles vaccination and "it knocked me on my butt, I still haven't got the second injection but I got shingles" and asked should she have gotten the COVID vaccine if she just got over shingles 3-4 weeks ago. She reported that she got her first dose of the COVID vaccine on 13Jan2021 and her second dose is scheduled for 30Jan2021 (17days apart). She did not have a question about the timing of the vaccine, only mentioned when her second dose was due and the it was 17 days after the first. She wanted to know if Pfizer was seeing a lot of this, and it could this her body reacting to the vaccine. She wanted to know what she should do with the second vaccine, if she should get it. She works at a school and has been making sure to wash her hands and everything. The outcome of the events Rhinorrhoea, and Vaccination site pain was unknown. The outcome of the event ageusia was not recovered while the outcome of the rest of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082498 same drug/event, different patients
70 2021-02-04 chills, fever, malaise Initially patient had fever of 100.7, chills, malaise, symptoms have resolved Patient took Advil now... Read more
Initially patient had fever of 100.7, chills, malaise, symptoms have resolved Patient took Advil now symptoms have resolved
70 2021-02-04 fever, fatigue Low grade fever; fatigue for 4-5 days post injection; This is a spontaneous report from a contactabl... Read more
Low grade fever; fatigue for 4-5 days post injection; This is a spontaneous report from a contactable nurse (patient). A 70-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 16Jan2021 08:00 at single dose for covid-19 immunisation. Medical history included Hashimoto's thyroiditis, celiac and allergy to wheat. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine, estradiol (ESTRACE) and colecalciferol (VIT D3). The patient experienced low grade fever and fatigue for 4-5 days post injection on 16Jan2021 at 16:30. Patient recovered from the events on Jan2021 and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.
70 2021-02-04 headache Shingles. Severe pain and blisters on right side shoulder neck and head
70 2021-02-04 fever, headache The following morning, I experienced a slight fever (99.1), mild headache, and pain to the touch at ... Read more
The following morning, I experienced a slight fever (99.1), mild headache, and pain to the touch at the injection site. These lasted only one day.
70 2021-02-05 headache 2/5/21 2nd Pfizer COVID vaccination ~1050. Began to feel nauseous, headache, increased BP. She had... Read more
2/5/21 2nd Pfizer COVID vaccination ~1050. Began to feel nauseous, headache, increased BP. She had these symptoms with 1st dose also. Was given acetaminophen 500mg po x 1 at 1100. During observation the headache began to resolve. Tends to get nauseated/car sickness and is currently on Prilosec. Placed on pulse oximeter and vital signs monitored. Symptoms are resolving during observation period and a friend is picking her up so she does not need to drive and friend will observe her the rest of the day.
70 2021-02-05 headache, chills Chills aches headache tylonol. Lasted about 24 hours
70 2021-02-05 headache, chills Chills, 6 hours, body aches 24 hours, headache 24 hours, foggy brain 24 hours
70 2021-02-05 headache, chills My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening,... Read more
My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening, but symptoms continued and migrated from there. The arm remained sore for 3 days and then began to itch. This itchiness continued on and off for the next 2 days. My neck and shoulder were also sore. The shoulder continued to be sore for about 4 days. I had an intermittent headache, also for 4 days. The worst part though, is the nausea, which also comes and goes. But it can last for many hours and now, even after 8 days, I am still experiencing this. I can find nothing in the writings about this vaccine to corroborate this side effect and I am therefore worried about the second shot.
70 2021-02-05 headache Severe headache, face flushing, swollen tongue, throat closing off
70 2021-02-05 sweating, chills, headache, fever Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By ... Read more
Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By 3am, had fever, chills, couldn't stop shaking or get warm, had headache, skin sensitive almost hurt when touched. Felt too bad to get out of bed but eventually got up, took acetimetophen, drank water, added clothes and blankets and returned to bed. Body kept tensing up very tightly so that all muscles were constricted/tights and impossible to relax. This continued for a few hours. By morning, I thought I was starting to feel better. These symptoms returns for a second round about 2pm that afternoon and continued until about 6pm. On the nights of 2/3, 2/4 and 2/5, I wake up around 3am extremely hot and sometimes damp, despite air temp of 66 to 68 degrees. This resolves after about an hour and body feels normal.
70 2021-02-06 headache, fatigue None stated.
70 2021-02-06 nasal congestion, chills, fatigue, influenza like illness, fever Severe myalgia, chills, fever - flu like symptoms, fatigue, dizziness, joint pain and bilateral met... Read more
Severe myalgia, chills, fever - flu like symptoms, fatigue, dizziness, joint pain and bilateral meta-tarsal pain on hands (which I used to have as part of my osteopenia. But was symptomless for a while). After about 18 to 20 hours after vaccination experienced severe bilateral metatarsal pain and joint pain on knees and back. Mild to moderate nasal congestion. Took 1 gram APAP /Benadryl alternating with ASA 325mg along with bedrest. Over the course of 2 days the pain (myalgia and arthralgia), flu-like symptoms and congestion resolved.
70 2021-02-07 cough, malaise due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but s... Read more
due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but she tested positive for COVID yesterday; Dizzy; starting to get foggy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899 or EH9897), via an unspecified route of administration at the left arm on 04Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing diabetic, blood pressure high, high cholesterol and sore arms from previous vaccines (unspecified).She had energy for a whole week after getting the vaccine, that she has not had for a long time, she even cleaned out her whole garage; has been waiting to do that for 3 years; had to make herself stop to rest. There were no concomitant medications. The patient got her first dose on 04Jan2021 and was due to get the 2nd dose this coming 25Jan2021, but she tested positive for COVID on 21Jan2021. She has been sick for a week which started with an irritating cough on 14Jan2021. She went to the ER because she was dizzy as could be on Jan2021. She does not remember which day; she was starting to get foggy on Jan2021. She was not admitted. She did a drive through rapid test on 21Jan2021 and it was positive. Lot numbers: Handwriting on her card was bad and she cannot tell if the last digit of the Lot number is a 9 or 7. The vaccine was administered in an open tent clinic outside in a parking lot outside a hospital and not in a military facility. The outcome of the event was unknown. Information on Lot/Batch has been requested.
70 2021-02-08 sleepiness Patient felt sleepy, blurry vision. BP 131/55 (pulse 62), O2 sat 100%. After rest, patient felt bet... Read more
Patient felt sleepy, blurry vision. BP 131/55 (pulse 62), O2 sat 100%. After rest, patient felt better.
70 2021-02-08 fever, chills Uncontrolled chills without fever for approximately 30 minutes
70 2021-02-08 fatigue, headache fatigue, headache, muscle & joint aches, mental fog
70 2021-02-09 fever, headache, chills Chills; Fever; Aches and pains/throbbing of a headache; Aches and pains/throbbing of a headache; Thi... Read more
Chills; Fever; Aches and pains/throbbing of a headache; Aches and pains/throbbing of a headache; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL9261, via an unspecified route of administration on 24Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included COVID-19 flu six months ago. There were no concomitant medications. The patient experienced chills on 25Jan2021 01:00 with outcome of recovering, fever on 25Jan2021 01:00 with outcome of recovering, aches and pains/throbbing of a headache on 25Jan2021 01:00 with outcome of recovering. Her symptoms all started about 1AM, she was woken up to them. Chills: they are better, she has an ice pack on her head for the throbbing of a headache. The action taken was not applicable. She wanted to take a Tylenol. It will probably go away tomorrow she was hoping to get some relief in the mean time.
70 2021-02-09 runny nose, sneezing, fever, influenza like illness Flu like symptoms, sneezing, runny nose, stomach pain and achy all over. Low grade fever one day.
70 2021-02-09 fever, malaise I had been running a temperature, I am usually 97.6 it was 99.1; I started to not feel good; This is... Read more
I had been running a temperature, I am usually 97.6 it was 99.1; I started to not feel good; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 18Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history included thyroid cancer and they took her thyroid (as reported). Concomitant medication included levothyroxine sodium (LEVOXYL) as she had thyroid cancer and they took her thyroid. Patient stated that she had first of her vaccine on 18Jan2021 (a week before the report was last Monday) and she felt fine, just the injection site (no further clarified). Starting on 23Jan2021 (reported as Saturday) she started to not feel good and on 24Jan2021 (reported as Sunday yesterday) she had been running a temperature, it was only like she was usually 97.6 it was 99.1 and she took paracetamol (TYLENOL) and it took the temperature down but she was wondering, patient called her doctor and she thought that it was too far, too many days have passed since the vaccination to have symptoms. Second dose scheduled for 08Feb2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.
70 2021-02-09 cough, fatigue face looks a little bit swollen; super tired; light dry cough /Light coughing; feeling like weaknes... Read more
face looks a little bit swollen; super tired; light dry cough /Light coughing; feeling like weakness; bone pain; muscle ache; She had some prior ache before but today it was stronger; This is a spontaneous report from a contactable consumer (daughter). A 70-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ8982 and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, blood pressure high, had Corona virus before in Nov2020, and ongoing ache. The concomitant medication was reported as Lisinopril at 10 mg, one tablet a day for Blood pressure high and Vitamins. Patient woke up this morning (23Jan2021) super tired, light dry cough and face looks a little bit swollen. No just tired, she was feeling like weakness, a lot bone pain or muscle ache like a lot. The patient had some prior ache before but today it was stronger. She still feels some pain. Treatment for bone pain or muscle ache, pain was Ibuprofen. The reporter wanted to know if these symptoms are common reactions to the vaccine; if the COVID-19 vaccine can give a COVID-19 infection; if patient should receive the second dose of the COVID-19 vaccine since she was having these side effects. The outcome of events, bone pain or muscle ache, pain was not recovered. The outcome of other events were unknown. No follow-up attempts are possible. No further information is expected.
70 2021-02-11 throat pain, cough Patient tested positive for COVID-19 on 2/4/21, she had symptoms of cough and sore throat on 2/2/21.... Read more
Patient tested positive for COVID-19 on 2/4/21, she had symptoms of cough and sore throat on 2/2/21. She was admitted to hospital on 2/12/21 COVID-19 pneumonia and hypoxic respiratory failure.
70 2021-02-11 chills blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumpin... Read more
blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; facial muscles became weak on both; difficult to make facial expressions; my mouth began to tremble; chills; facial muscles became weak on both; difficult to make facial expressions; This is a spontaneous report from contactable consumers. An 70-year-old female non-pregnant patient received her first dose bnt162b2 (BNT162B2; Solution for injection; lot number: EL9283) via an unspecified route of administration at Left arm on 28Jan2021 12:30 at single dose for COVID-19 immunisation at Clinic. Medical history included high blood pressure, high cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR), amlodipine, calcium carbonate simethicone. There was no other vaccines in four weeks. The patient previously took iodine had contrast, procaine hydrochloride (NOVOCAIN) had drug allergy, omeprazole (PRILOSEC) and had drug allergy, olmesartan medoxomil (BENICAR) had drug allergy. Five minutes after the injection 28Jan2021 12:35, patient felt blood pumping to her head and became very hot. Her face turned red and was hot to the touch. Then, facial muscles became weak on both sides and made it difficult to make facial expressions. Lastly, her mouth began to tremble and had chills. Symptoms subsided about 30 minutes after the injection. she worried about getting the second injection. The patient received treatment with Liquids/electrolytes. The events result in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in 2021.
70 2021-02-16 sweating, headache woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle wea... Read more
woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle weakness, could hardly sit up by myself, this was 2/11/21. I continued to feel these symptoms with lessening severity over the next 3 days until Sunday 2/14/21 at which time, late in the afternoon, I fell asleep and woke up drenched in sweat but feeling pretty much back to normal self and have felt normal self since then.
70 2021-02-17 malaise shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this wa... Read more
shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this was the 4th time; kidney infection; hurting on my waist around the back; diverticulitis; Her blood pressure went up to 211/92; does not feel well; afraid of taking it if it will be any worse; sick; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot: EL3248, expiry 30Apr2021), intramuscular on 23Jan2021 08:15 at a single dose in the left arm for COVID-19 immunization (prevention because she has autoimmune). Medical history included Behcet's syndrome and Sjogren's syndrome, both are overactive immune system problem/autoimmune diseases, which were diagnosed 20 years ago; diagnosed allergies; compromised immune status; respiratory illness; genetic chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; and patient have had shingles before. Family history was reported as none. Concomitantly, she was just taking daily medications that were not relevant. There was no prescriber for the vaccine. It was through a hospital. It was reported that vaccination was given at 08:15 to 08:30. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered the same date of the Pfizer suspect. Patient had not had prior vaccinations (within 4 weeks). Patient received her first dose of the Pfizer vaccine on Saturday 23Jan2021. She stated, on Tuesday 26Jan2021, patient was hurting on the waist around the back. On Wednesday, 27Jan2021, that next morning, she went to see her internal doctor and they thought a kidney infection or not; he was not sure if she had a kidney infection or what was going on. Patient went home and it got worse and patient went to the ER (Jan2021), also reported as ended up going to the ER. They did a CT scan gave her medicine. They did a CT scan and said it was not her bladder or anything (Jan2021). They thought it was diverticulitis; nothing helped. They gave her medication and she kept getting sick (2021). No further details provided on medication given. On Friday, 29Jan2021, early morning, patient went back to the ER, they did another CT with contrast it wasn't diverticulitis, but it was shingles, and patient have had shingles before, this was the 4th time. It was reported that when the doctor came in, he thought this was shingles and she has had shingles previously. She has had it about 3 other times and the pain was just off the scale (Jan2021). Her blood pressure went up to 211/92 and they were giving her morphine for the pain (Jan2021). She was questioning if she should get the second dose. She has two autoimmune diseases and it was an overactive immune disease. She took the one vaccine and her doctor said to contact Pfizer being as it is kind of new and especially since she has the autoimmune issues. She would like to know if it is safe for her to have the second vaccine. She does not know if she will be over this. She does not feel well (Jan2021). She was afraid of taking it if it will be any worse (Jan2021). Patient felt all right until she had the vaccine, on Tuesday the problem started (26Jan2021). They were giving her medication for the shingles and for the pain. Patient stated that "it set something off". Patient was still sick (2021), still taking pain pills. Patient didn't know how many days she has. Her second vaccine is on 13Feb2021. As sick as she has been, and her overactive immune system and if she still has the shingles those can last a long time, she doesn't want to go through what she went through. This was a lot of pain and with shingles they can last, 6 months or a year. The nurse called her back and told her to report to Pfizer. Patient was taking the medicine for the shingles right now. She doesn't know what will happen. She doesn't want to be sick. Patient asked for the efficacy after 1 dose and how much protection it has. She did fill out something because she talked with someone else. She confirmed it was through VAERS and not with Pfizer. She said the pain around her waist was a little better because they gave her the medicine for shingles and she has pain pills. She said one was Valacyclovir and she could not remember the name of the other. Patient had required two trips to ER. First one was on 27Jan2021 and went to internal medicine doctor and that night went to the ER. They did CT scan and it was not bladder or anything. Second visit on 29Jan2021 and did CT with contrast and the doctor thought it was shingles since she had shingles three times before. She has had them internally. The doctor said it would not necessarily need to be externally break outs. The next two times she did not break out. She did not have anything around her waist. Therapeutic measures were taken as a result of the events hurting on my waist around the back, kidney infection, diverticulitis, shingles, and sick. The outcome of the event hurting on my waist around the back was recovering. The outcome of the event kidney infection, diverticulitis, shingles, sick, blood pressure went up to 211/92, does not feel well, and "afraid of taking it if it will be any worse" was unknown.
70 2021-02-18 headache Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in... Read more
Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
70 2021-02-21 fatigue, chills, body temperature increased 27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature wen... Read more
27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature went up to 100.8. My chest was tight and achy and my oxygen levels stayed at about 88. I slept about 10 hours and woke up feeling fine. My chest is sore and achy but better than yesterday.
70 2021-02-21 throat irritation 5min after vaccine as per daughter, her mother began complaining of "burning " in her chest , itchi... Read more
5min after vaccine as per daughter, her mother began complaining of "burning " in her chest , itching in her throat, lump in her throat, hives/redness noted on throat and chest. RRT responded and accompanied patient to ED
70 2021-02-21 fever, headache, fatigue, chills 7 hours after injection, experienced extreme tiredness. Overnight, awoke with body aches, joint pai... Read more
7 hours after injection, experienced extreme tiredness. Overnight, awoke with body aches, joint pain, and injection site pain. Early morning awoke to body aches, headache, and extreme fatigue. While not chilled, needed three layers on top and two layers on bottom and on feet. Temperature at 8AM was 97.0. Voracious appetite and ate normally and with vigor. Slept for 3.5 hours and awoke to fever of 100.3 and voracious appetite. Ate normally. Body aches and joint pain were gone. About an hour later, temperature returned to normal but headache persisted. No longer fatigued, but still tired. Headache persisted that evening and still present at this writing, 8AM Monday.
70 2021-02-21 fatigue, sweating Approx. 1 hr. & 20 min. post injection, severe reaction: Severe upper abdominal pains, multiple, unc... Read more
Approx. 1 hr. & 20 min. post injection, severe reaction: Severe upper abdominal pains, multiple, uncontrollable formed to diarrheal bm's triggered vagal response, passed out, severe diaphoresis, violent chilling loss of control of bowel movements. Lasted approx. 30-35 minutes. crawled with head hanging to floor to keep from passing out, to locate a phone for help. after several of agonizing attempts to try and climb up to couch to elevate legs high above head and laying there for approx. 20 or more min. blood pressure came up some. (Did not call emergency services) afraid of hospitalization due to all chronic health problems, (forgot to report earlier that I am Hypothyroid as well) previously hospitalized for a Thyroid Storm. This is day 10 from injection and still have nausea, dizziness & fatigue, (also have couple episodes of abdominal pain). (I want to add that I felt completely fine prior to receiving 2nd Pfizer Covid dose). I am contacting my doctor today to receive some IV fluids.
70 2021-02-21 fatigue Aside from expected soreness at injection site, no adverse reactions through rest of Feb 10 and a... Read more
Aside from expected soreness at injection site, no adverse reactions through rest of Feb 10 and all of Feb 11 and 12 Starting February 13 and continuing through today (Feb 22), I have had the following symptoms: Vestibular migraine - very severe at the beginning, receding with time, but still concerning Nausea - on and off for full period, no relation to food intake Fatigue - tired most all of the time, could fall asleep at any time Balance - variable for this period, no falls, but do not feel safe to drive
70 2021-02-21 fatigue Dizziness that is continuing, fatigue, arm soreness, swelling of lymph nodes
70 2021-02-21 influenza like illness, fatigue Felt fine at first, but then suffered flu-like symptoms including extreme fatigue, stomach discomfor... Read more
Felt fine at first, but then suffered flu-like symptoms including extreme fatigue, stomach discomfort, gas, nausea, loss of appetite, acid reflux. Some symptoms have ceased or lessened, but extreme fatigue, lack of appetite and some stomach discomfort and acid reflux discomfort continues.
70 2021-02-21 headache, fever, chills Fever,chills,upset stomach, body aches,headache
70 2021-02-21 fatigue Hypercalcemia AKI encephalopathy acute vomiting fatigue acute ER 2/15 ICU 2/15 Hospitalized till 2... Read more
Hypercalcemia AKI encephalopathy acute vomiting fatigue acute ER 2/15 ICU 2/15 Hospitalized till 2/2021 IVs extensive electrolyte medications
70 2021-02-21 chills, fever Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took ace... Read more
Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took acetaminophen and some anti -nausea drugs I had on hand. Fever left, but returned next night. Weakness, no appetite stayed for two days. Thought it was the flu, but no upper respiratory symptoms. Thought it might be Covid-19 but tested negative. Finally decided it was a reaction to the vaccine.
70 2021-02-21 fatigue it felt like the reaction i generally have had with steroid injections for my spine. I was wide awa... Read more
it felt like the reaction i generally have had with steroid injections for my spine. I was wide awake all night. By the following afternoon I was exhausted and no longer feeling that effect. Nothing was done since it did not last. It was suggested that I report it since it is not mentioned as a side effect in the list of information.
70 2021-02-22 fatigue, chills, headache 2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, ve... Read more
2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, very tired/fatigue, moderate to severe upper body muscle aches, mild migratory chest pains for about 30 minutes. 24 hrs after injection just overwhelming fatigue& mild headache continued for another 12 hrs. 48 hrs. After injection symptoms gone.
70 2021-02-22 body temperature increased, sweating, lethargy 2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-g... Read more
2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.
70 2021-02-22 fever, headache Body aches, fever (102 F), headache beginning night of 2nd inoculation, continuing through next day
70 2021-02-22 headache, chills, malaise, influenza like illness I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. ... Read more
I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. There was a sense of nausea initially but it went away. There was pronounced feeling of heat located subcutaneously on my right outer thigh. It came and went about every minute or so. (I counted the seconds in between each incident). I am still experiencing flu like symptoms (bodily aches, slight headache, mild chest pain, and general ill-feeling.) I will contact my primary care physician today about my concerns but felt it necessary to document these mild but disturbing side effects.
70 2021-02-22 headache, fatigue Sharp stabbing pains in left hip socket, approx. 3 - 5 times/hour, with buckling of left hip if walk... Read more
Sharp stabbing pains in left hip socket, approx. 3 - 5 times/hour, with buckling of left hip if walking. Lesser joint pains in left ankle. Gradually resolving by Day 4. Tylenol 500 mg tablet taken on Day 3 was not effective. Minor symptoms: fatigue, mild headache.
70 2021-02-22 headache The patient began to have hot flashes and some dizziness. She felt "disoriented in her eyes," while ... Read more
The patient began to have hot flashes and some dizziness. She felt "disoriented in her eyes," while also having a slight headache. The feeling went away after 10 minutes and began 15 minutes after receiving her second Pfizer vaccine dose.
70 2021-02-22 headache When I left facility I had a mild headache. After getting on the highway face turned beet red with ... Read more
When I left facility I had a mild headache. After getting on the highway face turned beet red with mild swelling. Throat felt tight but not closed. An hour later the headache was worse. Took a Tylenol and slept for an hour. Woke up itchy. Glands on right side of neck very sore with pain radiating to base of skull. Swelling in face subsided after a few hours. Later at night I was still itchy with some small red hives on my arms, legs, and stomach. Arm very sore. Woke several times during the night with nausea. Woke up morning of the 20th with mild dizziness, upset stomach and severe diarrhea, Serious headache all day. Hives subsided but was still itchy. On the 21st felt much better but still with diarrhea. Today is the 23rd and no diarrhea since this morning.
70 2021-02-22 headache approx. 5 minutes after receiving the vaccine client started c/o nausea. She was given an antacid an... Read more
approx. 5 minutes after receiving the vaccine client started c/o nausea. She was given an antacid and it helped. She says by the time she got home she had a Headache that lasted off and on for 3 days. She took Excedrin and it helped.
70 2021-02-22 fever, headache pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the ... Read more
pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache. She felt like she had fever but she said it was only 99. Her left arm was swollen, red and hot around the injection site. Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
70 2021-02-23 headache 30 minutes after the shot my center of my nose and spreading to high upper lip and roof of my mouth ... Read more
30 minutes after the shot my center of my nose and spreading to high upper lip and roof of my mouth got numb. In addition I had a ?tickle? down the left side of my throat. Three days later I was itchy on my lower arms and upper legs. I also had a headache off and on for several days.
70 2021-02-23 headache, fatigue 3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visio... Read more
3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visions when eyes were closed, fatigue, VERY loud ringing in ears, tight chest, puffy eyes, heart racing & pounding 5th day:Diarrhea, fatigue
70 2021-02-23 headache, malaise A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizur... Read more
A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizure because my lack of control was evident in my movements. With my heaviest PJs on, it took 8 blankets to finally warm me up. I am on a CPAP machine but I was having a hard time getting my breath. I was also nauseous but never threw up. I finally got back asleep a little after 3 am but woke several times after that. This morning, I had a terrible headache and can't get rid of it. Although I feel better than last night, I feel lousy. It is now 2 pm and I just want this to be over. On the first shot, I didn't have any reaction at all.
70 2021-02-23 fatigue, fever, malaise, headache Body aches, felt feverish, weakness, headache, fatigue, overall malaise
70 2021-02-23 chills, throat pain, malaise, headache, fatigue Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Lo... Read more
Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.
70 2021-02-23 headache My mother complained of a severe headache within 1 hour of receiving the injection. 18 hours later s... Read more
My mother complained of a severe headache within 1 hour of receiving the injection. 18 hours later she was rushed to the the ER with a Hemorrhagic stroke. Hospitalized for 3.5 days, cognitive impairment remains, resulting in the need for rehabilitation therapy.
70 2021-02-23 sweating Pt. in tent 6 at observation lane felt throat tightness, sweaty palms. Paramedics assessed her once... Read more
Pt. in tent 6 at observation lane felt throat tightness, sweaty palms. Paramedics assessed her once the symptoms subsided paramedics released pt. to leave.
70 2021-02-23 headache, fever, nasopharyngitis, cough, fatigue, malaise arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then al... Read more
arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then also and found swelling like an orange, swelling lasted 8 days but was decreasing in size. became very cold and went into violent shaking tremors - 4-6 of those as i lost count. these violent tremors were from 10:30 pm on monday through 1:45 am tuesday. i had one other tremor on day 4. fever for 4 days and spiked on 5th day ranging from 101.8 - 100.3, severe all over body aching especially right armpit, lower back especially right side and across shoulders, aching lasted 8/9 days and lessened after 5 days. pressure on chest which ranged from very heavy to mild and in some form lasted 10 days, hurt to breath but i could breath. woke up on night 7 with heavy, painful chest pressure on left side but it subsided in 6-8 hours. nasty headache began day 2 and lasted several days; nothing relieved it. headache for 4/5 days and then off and on for a few days. i am not prone to headaches. coughing which lasted several days. on third day post vaccine had violent nausea one time. became weak and lightheaded. no energy and stayed in bed 5 days. on day six i started getting out of bed for several hours multiple times/day. weak and very low energy. exhausted easily. i had some of these symptoms for 10 days. the first 5 days were terrible and i was very ill.
70 2021-02-23 headache, body temperature increased, lethargy extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then ... Read more
extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then walked to parking garage. Breathing became labored as I walked the block to car - no one was around. Pulled off mask and sat in car - it subsided in 15 minutes. Body temp was 94.5 remainder of the day. 96.5 today. Awoke nauseated, headache, left foot and hand pain and very sore left arm. Nausea stopped about 3:00 pm, when body tremors started again. Cold all day with no energy
70 2021-02-23 sweating, chills nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to... Read more
nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
70 2021-02-24 chills After the vaccine my right arm was sore at the injection site. Later that night, after I went to bed... Read more
After the vaccine my right arm was sore at the injection site. Later that night, after I went to bed around 10:30 pm I started feeling nausea, followed by vomiting twice. Throughout the night I had body aches from head to toe. Also experienced body chills which continued the next morning.
70 2021-02-24 headache, fatigue Five hours after receiving the vaccine my husband I and were both extremely tired and fell asleep fo... Read more
Five hours after receiving the vaccine my husband I and were both extremely tired and fell asleep for about an hour - we were not able to complete simple tasks and went to bed early. My husband was up every half hour urinating from 6pm until about 3am. We both felt fine this morning but about 11am I got super dizzy and had to sit down, the dizziness caused vomiting and a sever headache. I laid down for about an hour and feel a bit better but the headache has remained!! Hopefully this too will pass in a few more hours! Just thought you might want to know. If it gets worse I will contact my doctor. My husband has not had any other adverse reactions.
70 2021-02-24 sweating Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vacci... Read more
Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vaccination waiting period, patient became unresponsive and exhibited convulsion like movements in her waiting chair. Pharmacist quickly evaluated patient and patient was only minimally responsive to painful stimuli only. Breathing was rapid, shallow, and irregular with an expiratory wheeze heard upon auscultation. Patient was slouched in chair but supporting self and had a strong grip with her left hand. Skin condition was warm but diaphoretic. Ambulance 911 service was called. No swelling of the throat, mouth, face, nor lips was seen. Patient continued to be non-responsive, with non-comprehensible sounds, and was not opening eyes or following commands. Due to worsening ability to breath and wheezing on expiration, epinephrine 0.3 mg was administered intramuscularly into the left thigh at 1230 on 2/25/2021. Approximately 5 minutes after epinephrine administration, the patient?s work of breathing improved, wheezing was diminished upon expiration, and respiratory rate had slowed to 16 breaths per minutes. BP was 160s/80s and HR 98 (after epinephrine administration). Patient began opening eyes spontaneously but was still not following commands. Ambulance service then arrived, report was given, and patient was transported to Hospital Emergency Department. Patient was under the care of Doctor at the emergency department and received albuterol/ipratropium nebulization, dexamethasone 10 mg Iv, famotidine 20 mg IV, and magnesium sulfate 2 g IV. After the physician evaluated the patient and talked with family, the patient?s family stated that the patient has a history of anxiety related reactions such as this with convulsion like activity. Doctor then determined that the patient did not have an anaphylactic/allergic reaction and instead had a anxiety related vasovagal type reaction. Doctor stated that the patient could receive the second COVID-19 vaccine dose in 3 weeks without issue. Patient then discharged from Emergency Department (unsure if AMA). Patient then presented to the pharmacy with her daughter after discharge to fill in staff on the outcome of the reaction. Patient appeared to be at baseline mentally and physically. Pharmacist contacted Emergency Department to discuss case with patient?s nurse to obtain information about medications received in the emergency department. Patient daughter stated that she would like to be present for second dose of vaccine to help avoid a similar anxiety related reaction from occurring.
70 2021-02-24 sweating Rapid heartbeat, lightheaded, sweating, about 5 min duration. Then again 23 hours after vaccination.
70 2021-02-24 headache Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face beco... Read more
Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face becoming hot, her cheeks being red, and a headache. EMS evaluated patient on-site. Patient was hypertensive (206/96). EMS transported patient to Emergency Department for further evaluation. In ED, patient was still hypertensive, but in no acute distress. Per patient, she was taken off losartan by PCP in September secondary to hyperkalemia. ED physician administered losartan and Tylenol. Patient was discharged with HTN, HA, and vaccine reaction.
70 2021-02-24 lethargy did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; ... Read more
did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; chest was killing me and hurting and I was sobbing and it lasted about an hour and 15 minutes; Side of my neck hurt; My back hurt; It was just awful; Lethargic; I ended up vomiting for 2 days after the chest pain receded; slept for 16 hours; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients (husband and wife). This case refers to the wife with serious adverse events. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration was not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux. Concomitant medication included dexlansoprazole (DEXILANT) for acid reflux. Patient reported that she had terrible severe reaction on the 22Jan2021. They were vaccinated on the 18Jan2021 and on the night of the 22Jan2021, she had such crushing chest pain that she just collapsed. Her chest was killing her and hurting and she was sobbing and it lasted about an hour and 15 minutes. The side of her neck hurt and her back hurt. It was just awful. Patient reported that she have called everybody. She have called her doctor's assistant and she confused her. Patient reported that they just went in because they were 70 and 71 and got the vaccine but then she ended up vomiting for 2 days after the chest pain receded and they took baby aspirin and then she just vomited and vomited and slept for 16 hours. They were both very lethargic. She asked her what should she do. She does not know if this was a reaction to the vaccine or did she have a heart attack. No doctor will see her to give me an EKG. They say they are not seeing patients. The patient recovered from chest pain on an unspecified date; while outcome of the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115775 same reporter/drug, similar event, different patient.
70 2021-02-25 chills I received my first Pfizer Covid injection Feb. 18, 2021. I experienced chills, nausea, some flu s... Read more
I received my first Pfizer Covid injection Feb. 18, 2021. I experienced chills, nausea, some flu symptoms starting Feb. 22 Monday evening - Feb 25th. I threw up Wed. Feb. 24 morn. I started feeling better on Friday, Feb. 26th and resumed normal activities. My temp from Feb. 22 - 25th was 96.1. I also experienced flu symptoms and felt as if "a truck ran over me".
70 2021-02-25 throat irritation Problem swallowing , scratchy throat. Duration <60 minutes.
70 2021-02-25 fatigue, chills, influenza like illness Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for ... Read more
Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for workup of myalgias, nausea, fatigue. Per ED note "chills, onset 4 days ago. Pt recently had the COVID19 vaccine and since, has been experiencing "flu like sx's" and "she feels horrible". She tried imodium, with minimal relief. Endorses abd pain, nausea, diarrhea, GERD, feeling gassy, trying to stay hydrated, decreased appetite. Denies fever, sore throat, congestion, cough, urinary sx's, SOB, CP. Patient is otherwise healthy and has no other complaints." Workup negative, prescribed zofran and discharged home without escalation of care.
70 2021-02-25 headache, chills Rapid heartbeat Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of ... Read more
Rapid heartbeat Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of tongue Chills, weakness, headache, blurred vision for a short time Took Benadryl on my own, continued taking non drowsy Claritin 5 days after shot feeling better. Still have slight numbness in my lips and feeling weak
70 2021-02-25 headache, chills, fever chills starting 7 hours after shot muscle aches, headache fever 100.5 starting 16 hours after ... Read more
chills starting 7 hours after shot muscle aches, headache fever 100.5 starting 16 hours after shot fever of 101.4 one day following shot fever lasting 3 days along with severe headache and muscle aches
70 2021-02-25 headache slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous repo... Read more
slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 10Feb2021 at 16:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included type 2 diabetes mellitus, hypertension and allergy to Victoza. Concomitant medications included metformin, dulaglutide (TRULICITY), atorvastatin and fluoxetine. On 10Feb2021 at 21:00 about the patient five hours after vaccine in kitchen washing dishes, passed out. No symptoms or light headedness leading up to this event. Patient woke up on floor hit head minor and knees. On 11Feb2021 the patient complained slight soreness on head, fuzzy feeling. Knees extremely sore, small cut on ankle. Her doctor adviced to report this due to the time event happened in relation to vaccine (as reported). No treatment reported for events. At the time of the reporting the patient was recovering from the events. .
70 2021-02-25 nasopharyngitis, nasal congestion stuffy nose; like a cold but it doesn't feel the same as a cold; This is a spontaneous report from a... Read more
stuffy nose; like a cold but it doesn't feel the same as a cold; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3246), intramuscular at Arm Left on 17Jan2021 07:30 at the 70 years old at single dose for COVID-19 vaccination. The medical history included asthmatic. The concomitant medications were none. The patient had the first dose of the vaccine on the morning of 17Jan2021 and that afternoon on 17Jan2021 she started having a stuffy nose like a cold but it doesn't feel the same as a cold. This has been occurring for 9 days now. She called to ask if this was one of the more obscure side effects of the vaccine. The patient received the vaccination on the 17Jan2021, and in the afternoon of that day, she got a stuffy nose. She said that she did not see it as a side effect, but 9 days later she still has a stuffy nose. She said that she does not have a temperature, headache, or anything else going on. She said that she knows a stuffy nose is a side effect of Covid-19 though. The caller said that she has been reporting this on the (App Name) everyday. The patient said that the stuffy nose was the same as it had been. The patient said that she was not feeling sick, sick, just stuffed up. She did not have shortness of breath or anything like that. There was no History of all previous immunization with the Pfizer vaccine considered as suspect. The events did not require a visit to Emergency Room and Physician Office. There was no family Medical History Relevant to events. There was none Prior Vaccinations within 4 weeks. There were none relevant tests. The outcome of the events was not recovered.
70 2021-02-26 fever, sweating, fatigue, chills Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweat... Read more
Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweating, tiredness, slight nausea, intermittent headaches, strong muscle and joint pains, slight swollen glands in neck
70 2021-02-27 headache, chills, nasopharyngitis, fatigue Freezing cold to the point of shivering and teeth chattering - chills, headache, body ache, foggines... Read more
Freezing cold to the point of shivering and teeth chattering - chills, headache, body ache, fogginess, extreme fatigue. Tylenol every 6 hours. Cold packs on head and neck. All except headache went away by Friday, 2/26/2021.
70 2021-02-28 sweating "Sweaty" which lasted for 10 minutes and then resolved
70 2021-02-28 throat irritation About 20 - 25 minutes patient developed scratchy throat in the parking lot after initial 15 minute o... Read more
About 20 - 25 minutes patient developed scratchy throat in the parking lot after initial 15 minute observation period. Was brought back to Observation for assessment. Denies other sx (no SOB, palpitations, sensations of lip or throat swelling, itchiness, etc.) Patient observed for additional 20 minutes . Symptoms improved and no development of additional or denied symptoms. Patient requested to leave after repeat observation. Discharged with strict ED precautions. All questions answered.
70 2021-02-28 headache Pfizer-BioNTech COVID-19 Vaccine EUA: During observation period, vaccine recipient complain of throa... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: During observation period, vaccine recipient complain of throat tightness and headache. They were monitoring by EMS. No further intervention needed.
70 2021-02-28 fever, chills, headache eyelids became puffy; eyes became glassy; fever; body aches; chills; bad headaches; implanted breast... Read more
eyelids became puffy; eyes became glassy; fever; body aches; chills; bad headaches; implanted breast skin became blotchy; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E63247) , via an unspecified route of administration in the right arm on 01Feb2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included Raynaud's syndrome, chronic lymphocytic leukaemia, irradiated thyroid gland, high cholesterol, previous breast cancer, allergy to latex and adhesives, and breast implants. Concomitant medications included levothyroxine sodium (SYNTHROID); rosuvastatin (MANUFACTURER UNKNOWN), and unspecified multivitamins. The patient previously took povidone/iodine (BETADINE) on unknown dates for an unknown indication and experienced drug allergy. On 05Feb2021 at 21:00, the patient experienced fever, body aches, chills, bad headaches, and implanted breast skin became blotchy. On 07Feb2021, the patient's eyelids became puffy and eyes became glassy,. All the events were reported as serious for disability. The peak temperature was 101 degrees Fahrenheit on an unknown date in Feb2021. The patient contacted the doctor, eye care professional and hematologist/oncologist for the events. On 08Feb2021, the patient had a COVID-19 nasal swab PCR which was negative. The patient was not treated for the events. The clinical outcome of the fever was recovered on 12Feb2021; while that of the body aches, chills, bad headaches, implanted breast skin became blotchy, eyelids became puffy, and eyes became glassy were recovering.
70 2021-02-28 chills, sweating hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, v... Read more
hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, vomiting, chills--resolved after 9 hours
70 2021-03-01 malaise Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out ... Read more
Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out of sorts; feeling light headed; This is a spontaneous report from a contactable consumer (patient) who reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number:EL3246), via an unspecified route of administration into the right arm on 10Feb2021 07:45 at a single dose for COVID-19 immunisation. Medical history included known allergies to CT dye, COVID-19 from an unknown date prior to vaccination and known allergies to sulfa drugs. Patient was not pregnant. Patient had unspecified concomitant medications. On 11Feb2021 08:00, patient woke up feeling out of sorts and feeling light headed, patient sat down and the next thing she knew she was on the floor bleeding from a small gash in her head, she lost consciousness for a brief period and also broke her finger. The events required emergency room and physician office visit. The patient had 3 staples in her head and a finger splint for the events "bleeding from a small gash in her head" and "broke her finger". Outcome of events was recovering.
70 2021-03-02 nasopharyngitis, malaise, fatigue all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size... Read more
all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; redness of the skin; whole body was in pain; severe allergic reaction; felt unwell; Joint muscle pain; flushed red; Tiredness; Injection site pain; joint and muscle pain; joint and muscle pain; white blood cell count on the lower side; possible damage to the kidneys; could have been possible that she had COVID and was asymptomatic, or she had it; cold; not feeling normal; This is a spontaneous report from a contactable consumer (patient) Medical information team. A 70-years-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13Feb2021 at single dose for COVID-19 immunization. Medical history included dystonia and migraines from an unknown date and unknown if ongoing, COVID-19 antibody test positive from Nov2020 to an unknown date. The patient was taking unspecified concomitant medication for dystonia and migraines. The patient experienced a "severe allergic reaction" to her first dose of BNT162B2 in Feb2021. She had all-over body rash that was "very red, like a tomato" and showed up 35-40hours after her dose. She states her doctor does not recommend she get the second dose. The patient meant by allergic reaction, she had a number of things, she experienced tiredness, injection site pain, joint muscle pain, she felt unwell, this all happened on the Saturday, the same day she got the vaccine on 13Feb2021. Then on Sunday 14Feb2021, all the symptoms she spoke about were still there and so she rested all day. On 15Feb2021, she looked at her elbows, clarifying the inside of elbow, her elbow creases, and on both elbow creases the skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen down to her thigh, it was working it's way down to the knee, the color was like a beet red, tomato color, it was under the arms, started with elbow, was at her neck. The more down the redness spread, the more it red in color it also got. When she noticed this she called the doctor. When she called the doctor, the doctor said get over to the Emergency Room right away. Her husband and her were both on the phone and were telling the doctor that she doesn't want to go to hospital, she asked if she can just come into the doctors office. The doctor said No. He told her that needs to get special lab work done, and he needs to send her information over to the ER. He said this could do possible damage to the kidneys. The doctor said lets not forget the last time she did a blood test, which was in Nov2020, at that time she came up positive with COVID antibodies. It could have been possible that she had COVID and was asymptomatic, or she had it. The doctor said that they need to do another COVID test or it could be she had a COVID cold or a cold with antibodies, her doctor doesn't know. The fact that she had that test that came back with COVID antibodies test but not have COVID in Nov2020 was something to consider. He was concerned may be there is more to this, or just a rash. The doctor said that he is not equipped say what it should be. The doctor said he will speak with them at the hospital. Tiredness subsided yesterday afternoon on 15Feb2021, it subsided before she went to the ER visit. Right now, it's kind of like a lasting effect because she is not feeling normal. The injection site pain was still there but not as bad. The joint muscle pain subsided this afternoon around 1 o clock. It first began a half hour after leaving the stadium and she was experiencing it while driving back home, the pain continued and got worse. When she got up on Sunday morning her whole body was in pain, she was not getting better on Sunday and that's when she sat on couch rest of the day. For red skin, with the temperature of the skin, she didn't feel it to see if it was hot or anything, it was more this feeling that its just not going away getting worse, it didn't feel hot, there was no texture on the skin either. She just noticed she was flushed red. She called the doctor first, and he said that he was sending information to the emergency room. Then she went to (name of place withheld) ER. They took her temperature, there was no fever. She was then relieved from the ER in 2.5 hours and went home. She still has redness on the skin. In the hospital, they gave her 40 mg of prednisone and an injection or Benadryl, and prescription for prednisone to take for the next 4 days while tapering down. She did take Benadryl about 2 hours ago, she did notice all the sudden she was getting itchy. She is less itchy now. With the itchiness, she just observed this about 2 hours ago. She took Benadryl, she has somewhat improved, she is still itchy but not to the point that she will scratch heavily. She does not have her COVID CDC Card at the moment, her husband has that information but he is on a conference call with a client and she cant disturb him. The patient was scheduled for a second dose on 06Mar2021. That's where she has a question, the doctor is saying that he is not sure about getting second shot. They took lab work at the hospital and said everything was fine except for white blood cell count, it was on the lower side in Feb2021. She has had no vaccines on the same day or in the 4 weeks prior. She hasn't had any vaccines. She did have to visit the emergency room. She only called the doctors office, the doctor said not to come in and go tot he ER. She has No relevant family medical history that she would like to share. The severe allergic reaction, "skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen", injection site pain, redness of the skin, itchiness, joint muscle pain and whole body was in pain was recovering. The event tiredness recovered with sequelae on 15Feb2021 and the event joint and muscle pain was recovered on 16Feb2021. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
70 2021-03-02 chills, fever, headache, fatigue, malaise fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no uri... Read more
fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no urine output for 24 hrs, vertigo, fatigue, severe stabbing pains in face and head, stiff neck, no appetite, difficulty swallowing, pain in joints, chest pain, pain across upper back, stomach pain,. Symptoms lasted for 3 to 4 days. Severe head pain lasted 4 days. Could not raise left arm for 24 hrs after injection. After 6 days fatigue and general malaise still present. Stomach pain still comes and goes.
70 2021-03-02 fever, headache, chills rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping;... Read more
rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information team. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included anaphylaxis with insect bites from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and diazepam (VALIUM) and experienced hyperkinetic reaction. The patient stated that she received the vaccine on 14Jan2021, and that day 6 hours later, she had headache, fever, chills and body ache; and the next day on 15Jan2021, when she woke up, she had rash on legs, arms, chest and stomach, and she still had the rash. On an unspecified date, the patient had 3 days with out sleeping. The patient assessed the events as non-serious. The patient further reported that she was hyperkinetic and she has had that reaction many years prior reporting, before when taking codeine or VALIUM, one of the ingredients in VALIUM. She went to the doctor the first day, who saw her rash and told her to report that. It was not itching. The patient had the appointment for the second dose of the Pfizer vaccine, this coming Thursday and wanted to know if there would be a problem to get the second dose. She was afraid to get the vaccine the first time, because she had a history of anaphylaxis with insect bites. She carried an epi pen, and the vaccine provider had one too and the paramedics was there, and everything was okay; they were nice with her. The patient didn't have any problem until later. The patient spoke to her health care professional and he thought it was okay for her to get the second dose and the health care professional just told her to put a cream on her rash. Therapeutic measures were taken as a result of rash on legs, arms, chest and stomach, which included putting a cream on her rash. The patient was not recovered from the rash on legs, arms, chest and stomach, while the outcome of the events "headache, fever, chills, body ache, and 3 days with out sleeping" was unknown. No follow-up attempts are possible. No further information is expected.
70 2021-03-02 headache wrist pain; wrist pain and it locked up.; little bumps on the back of her hand; Headache; This is a ... Read more
wrist pain; wrist pain and it locked up.; little bumps on the back of her hand; Headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EJ1686) on 03Jan2021 in the morning before 12:00 pm (at 70 years) at single dose in right arm for COVID-19 immunization.Medical history included hypertension from 2002. Concomitant medication included enalapril for hypertension from 2002 (she tried several things- unspecified-before enalapril, took a number of months before she found something to tolerate). The patient on 24Aug2015 (at 65 years) took varicella zoster vaccine live (oka/merck) (ZOSTAVAX) for immunization and experienced shingles (it started a couple months after the shot, she had skin discoloration, black spots over the skin, caused by her bathing suit and the pool water, and it stayed for about 1.5 years, she was using a cream. It was maybe 2 years before it disappeared). Patient received first dose of the vaccine on 03Jan2021, after in Jan2021, she had a headache, a week and half later pain in wrist and wrists locked up, pain floated up to the back of her hand, continued since, locking of wrist stopped, pain continued, little bumps came on the back of hand.Patient added she may have had headache the second day (as reported), it came and went, she didn't pay attention, she had a headache morning and it gone as of 15Feb2021, but still came and went. Wrists locking up recovered before 24Jan2021. Bumps on back of hand started the same time, it came and went, stayed most of last week, still had it this week, about the same.No blood tests done since this happened.Final outcome of headache was unknown. Wrists locking up recovered in Jan2021. Bumps on back not recovered. wrist pain was recovering.Patient took the second dose of the vaccine (lot EN5318) on 24Jan2021 in the afternoon (maybe 2 or 3:00PM) at single dose in left arm for COVID-19 immunization. On 12Feb2021 patient lost part of mobility in the small finger of the right hand, can't lift it all the way above. Patient was scheduled to go to the doctor on 15Feb2021 in the afternoon. Patient saw joint pain listed on contraindications, would like to know the nature of the joint pain described from side effects of the covid vaccine. She was concerned of a blood clot, unsure what happened or what can cause it, was unsure if it was muscular or something. Patient would like to know whether blood clots and muscle pain have been reported as a side effect of the covid vaccine.
70 2021-03-03 chills Foul smelling urine Feeling of fogginess Intermittent chills
70 2021-03-03 headache Headache not mediated by over the counter pain meds
70 2021-03-03 fatigue, headache, fever I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose, I de... Read more
I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose, I developed mild fever (under 100)*F, a bad headache, blurred vision, nausea, joint pain and fatigue. I took Tylenol for the fever and headache and recovered after 2 days. However, on 2/28/21 I developed a SECOND SERIES OF SIDE EFFECTS starting 8 days after the 2nd dose. I developed a fever of 100.7*F , a bad headache, nausea, palpitations, and severe joint pains and strong fatigue. I consulted my PCP, who recommended I fill out this report. I took Advil on 2/28, improved after 2 days, and now have a slight headache and some fatigue but otherwise recovered.
70 2021-03-03 lethargy, chills, fatigue Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upo... Read more
Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upon waking next morning). Sore/stiff neck within 14 hours. Body aches, chills within 16 hours. Stomach/abdominal discomfort within 20 hours. Diarrhea at 36 hours. At 36+ hours - arm pain considerably less. Body aches and chills gone by 36 hours. Continued stomach/abdominal discomfort seems to be improving after 40 hours.
70 2021-03-03 fatigue Severe fatigue and body aches and day 4 a severe rash on my back that lasted two weeks. Treated wit... Read more
Severe fatigue and body aches and day 4 a severe rash on my back that lasted two weeks. Treated with OTC steroid lotions.
70 2021-03-03 chills, fatigue, malaise right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen ... Read more
right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
70 2021-03-03 malaise, fever, chills, fatigue severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wh... Read more
severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wheeze; she is also shaky; general malaise; heart attack; and last night she drank some water and choked on it then couldn't get her breath and; chest was hurting radiating to my arm down; fever; chills; exhausted/just felt very tired; her arm that was sore was the one where she had her injection; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9810), via an unspecified route of administration (on left arm) on 15Feb2021 (at the age of 70 -years-old), single dose for COVID-19 immunization. Medical history included asthma, sleep apnea, thyroid problem, prediabetes, cpap use, all from an unknown date. There were no concomitant medications. Patient reported her face is blood red. Last night her chest was hurting radiating to my arm down. It felt like someone was strangling her with water. She noticed my symptoms were what people experience after receiving the second dose. She had fever, chills, exhausted and just felt very tired after receiving the first dose. She still have trouble breathing. She had severe asthma. She was not breathing normally. When she put the mask on it's even harder to breath. She was worried. She thinks, she might have the coronavirus. Consumer says that she is still not feeling well after receiving her first dose of the Pfizer COVID-19 vaccine on February 15th. She says that the first day after getting it, she had pain in her arm, it was achy, it was not really painful enough to where she had to take Tylenol for it. She says yesterday on the second day she had fever, chills, tiredness, general malaise, and today she is not feeling well. Caller says she was having trouble breathing, and did a treatment with her nebulizer which she has because she has real bad asthma. She says her breathing is labored and she wheezes every once in a while. She says she would like to see if there is anything that she needs to do, because she works with children, and if she is coming down with the corona virus she doesn't want to be around them with it. She says that her breathing is problematic today. She says she doesn't think that she is having a severe reaction, she has no rash or those kind of symptoms. She says it seems to be just the asthma, and last night she drank some water and choked on it then couldn't get her breath and her chest hurt and she had pain down her arm and thought oh gosh she was having a heart attack.Caller says she has done no treatments other than the nebulizer treatment. No further details provided about the nebulizer treatment. Caller says the provider said no Tylenol right away, so she didn't take any yesterday with her fever, and she didn't have a thermometer to take her temperature, but her face was really hot and she was having chills, which usually means she has a fever. She says that her arm that was sore was the one where she had her injection. She says that never really was that bad, everyone said their arm had ached, and she has a high pain threshold so it never bothered her. Her wheezing and little trouble breathing was better, after she did some breathing treatments with the nebulizer, she is not breathing well but she is breathing better. She says she is also shaky and doesn't know if that is just nerves, or if this is also something going on. Caller says that it has been a while since she had blood work, which was the last time she went to see physician, but she doesn't know the results for what they found out. The outcome of the events Breathing difficult,wheeze was recovering, other events was unknown.
70 2021-03-03 runny nose, nasal congestion suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; congestion; running nose; This i... Read more
suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; congestion; running nose; This is a spontaneous report from a contactable consumer reporting for his/her mother. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Jan2021 (when 70 years old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, congestion, running nose, chills, cough, covid 19 symptoms on 02Feb2021 with outcome of unknown. The reporter wanted to know what kind of the covid test should she get done and if the patient could take the second dose on 08Feb2021 or should she wait. Information on the lot/batch number has been requested.
70 2021-03-04 fever, headache 2nd dose at 1615 on March 4, HA started morning of the 5th, pt called and spoke with triage RN at 14... Read more
2nd dose at 1615 on March 4, HA started morning of the 5th, pt called and spoke with triage RN at 1400, triaged per protocol and pt directed to ED for "worst HA of life". Pt also endorsing fever, nausea, "sparkles" in vision of 1 eye. Pt took tylenol and advil w/o relief (doses unknown).
70 2021-03-04 fatigue, headache, sweating, chills Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by swea... Read more
Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by sweating hands/palms followed by feeling very cold and then cycling back to hot flash, more sweaty palms, & back to chills. Minor nausea. Lasted from 8:15am til 11:30am. I called my care team at clinic they suggested that I call "911", but I did not call "911". My daughter who is a nurse came over to my house & stayed with me until 11:30am. On 03/05/2021 I woke up at 8:00am with a mild headache, minor muscle aches, tired, a little brain fog, & minor nausea which is continuing as of 10:35am as I am completing this form.
70 2021-03-04 fever, chills, malaise From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches.... Read more
From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches. General ill feeling. Couldn?t go to sleep. Began to feel horrible. Cold feet. Took an Advil and within 15 minutes all symptoms went away.
70 2021-03-04 headache My last injection was on 1/28/21. That day and few days after I had no site pain. I did have aches... Read more
My last injection was on 1/28/21. That day and few days after I had no site pain. I did have aches and pains and bad headache and chest pressure for hours during the night which I reported and which disappeared next day. However, the site pain in my right arm continues and is pretty bad temporarily and also periodically. Not a big deal but decided to report it. Seems very odd since it's been so long.
70 2021-03-04 cough, headache, fatigue, respiratory tract congestion Significant COVID symptoms short of hospitalization including aches severe headaches congestion ling... Read more
Significant COVID symptoms short of hospitalization including aches severe headaches congestion lingering cough fatigue diarrhea
70 2021-03-04 chills Swelling to lips (angioedema), soreness, chills
70 2021-03-04 fatigue, chills, fever, sweating chills, fever, sweats, tiredness
70 2021-03-07 headache, fatigue Aches, stiff joints, headache, very tired & very, very sore arm
70 2021-03-07 dehydration, headache, chills Patient received first Pfizer COVID-19 vaccine on 1/20/2021 and second dose on 2/12/2021. Patient ha... Read more
Patient received first Pfizer COVID-19 vaccine on 1/20/2021 and second dose on 2/12/2021. Patient had minor symptoms such as body aches with both vaccine doses which resolved. Patient then stated she started to experience headache, nausea, and body aches, decreased oral intake, and chill starting on 2/18/2021. On 2/20/2021 patient had several loss of consciousness episodes. Patient presented to the Emergency Department on 2/21/2021 with a chief complaint of syncope, nausea, and vomiting and subsequently admitted to the hospital for potential sepsis, syncope, hyponatremia, dehydration, lactic acidosis. (Continued on second page)
70 2021-03-07 chills, fatigue, sweating began to pass out; because every time I tried to lift my head, I would start blacking out again; diz... Read more
began to pass out; because every time I tried to lift my head, I would start blacking out again; dizzy; diaphoresis; fell against the wall; violent high abdominal pain; n having multiple, large formed bowel movements; shaking; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer. This 70-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EM9809) , via an unspecified route of administration on 12Feb2021 at 09:45 (at the age of 70years old) at single dose for covid-19 immunisation. Medical history included hypersensitive to latex, allergies to levaquin, ddavp, CT scan dye, codeine, fentanyl, primary immune deficiency, myasthenia gravis, Sjogren's, autonomic neuropathy, myelodysplastic syndrome, von Willebrand's, Barrett's esophagus on unknown date and unknown if ongoing and received Pfizer Covid vaccine (dose 1, Lot: EL9261) on 22Jan2021 at 2:45am on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant concomitant medication was not provided. At approximately 9:50 AM on 12Feb2021, the patient received second Pfizer Covid-19 vaccine in left arm at Administration facility. The patient waited the 15 minutes post injection. At approximately 10:19AM, the patient left site & drove to her home without issues. At home approximately at 11:20am, she had violent high abdominal pain like she never had before. she proceeded to the commode and began having multiple, large formed bowel movements then began to pass out. She began to have diaphoresis and violent shaking and chills. She had passed out on commode and fell against the wall. She later managed to pull pants up and crawl with head hanging down stated that because every time she tried to lift her head, she would start blacking out again. This continued until after approximately 20 minutes. She managed to pull herself up to the couch and raise legs high above heart and head and let head hang off couch to restore blood pressure. The patient mentioned that shot triggered something with her autonomic nervous system. On 22Feb2021, she was still with nausea, fatigue and dizziness. The outcome of events was not recovered. No treatment was received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
70 2021-03-10 headache Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mo... Read more
Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mouth, neck, shoulder; Muscle type convulsions in neck, shoulder, arms and upper chest; This is a spontaneous report from a contactable consumer reported for self. This 70-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via intramuscular on 24Feb2021 at 10:00 AM at single dose in left arm in a pharmacy or drug store for COVID-19 immunization. The patient's medical history included high blood pressure. The patient had known allergies: anabolic steroids, many antibiotics. The patient did not have COVID prior vaccination. The patient's concomitant medications included hydrochlorothiazide, triamterene (MAXZIDE) and vitamins. At 24Feb2021 at 10:00 PM, the patient experienced muscles in neck, jaws and throat started clinching up and she could not swallow. The patient began having issues breathing. The patient was advised to go to emergency room (ER). At ER, patient started with muscle type convulsions in neck, shoulder, arms and upper chest. The patient had several episodes. Doctor administered diphenhydramine hydrochloride (BENADRYL) intravenously, did blood and urine workup. After 4 hours the shaking stopped, and the muscle contractions lessened. The patient was sent home. Next day 25Feb2021, she still had some residual muscle tightness in right jaw, mouth, neck, shoulder. On third day 26Feb2021, she had light shaking of hands and arms. The patient was still taking 25 mg diphenhydramine hydrochloride every 8 hours. She added ibuprofen (ADVIL) because she also had muscle pain and headache. The patient was recovering from the events. The patient did not test COVID post vaccination. Information on lot/batch number has been requested.
70 2021-03-11 pneumonia reveled mild pneumonia; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vacci... Read more
reveled mild pneumonia; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262; expiry date: unknown) via an unspecified route of administration in the left arm, on 28Jan2021 at 15:00, at a single dose, for COVID-19 immunisation. Medical history included known allergies to penicillins. Concomitant medication included acyclovir (ACICLOVIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) in the left arm, on 06Jan2021 at 13:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccination. The patient had dry cough and difficulty getting deep satisfying breath about 12Feb2021 (2 weeks + 2 days) after 2nd dose of Pfizer vaccine. The patient tested positive for COVID-19 nasal swab on 19Feb2021 (3 weeks +2days) after 2nd dose of vaccine. On 24Feb2021, patient was seen in a physician office for symptoms of cough and shortness of breath (SOB). On the same day (24Feb2021), chest X-ray revealed mild pneumonia. Patient was now on prednisone, azithromycin and albuterol inhaler. Patient was a little better and was now on 3rd day of taking 3 medications. Outcome of the events was recovering.
70 2021-03-14 fever, headache, fatigue, chills Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spont... Read more
Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot#: EN6202, expiration date unknown) on 23Feb2021 at 12:15 AM at the age of 70-year-old at single dose via an unspecified route of administration at left arm for COVID-19 immunization. Patient was not pregnant at time of event and at the time of vaccination. Medical history included allergy to sulfa. Patient previously received 1st dose of BNT162B2 (Lot#: EL9264) on 02Feb2021 at 02:00 PM at the age of 70-year-old at left arm for COVID-19 immunization. Concomitant medications included raloxifene, fish oil, ergocalciferol (VIT D) and calcium. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced chills, fever, extreme fatigue, muscle achiness, headache, swollen arm, rash on arm; all on 23Feb2021 at 15:00. Outcome of the events was recovering. No treatment was received for the events. Events were reported as non-serious. Events didn't result in emergency room visit or physician office visit. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.
70 2021-03-14 headache syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; sor... Read more
syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
70 2021-03-15 malaise, fatigue few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionall... Read more
few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason; Vomiting; exhausted all day from being sick; exhausted all day from being sick; feeling slightly queasy/queasiness; diarrhea actually started before 1 AM/but was mild and escalated and by 1 AM it was extremely bad; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9264; Expiration Date: May2021), intramuscular, administered in Arm Left (left upper arm) on 25Feb2021 11:00 (at 70-year-old) at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Vaccination Facility Type was clinic. The patient previously took flu shot (she took the flu shot every fall and she has never had a reaction like this). It was reported that the patient started feeling queasy within 1 hour of the dose the same day. She confirmed by 1 AM 26Feb2021 she had diarrhea and vomiting which was about 14 hours after shot. She says the diarrhea actually started before 1 AM, so could have been 25Feb2021, but was mild and escalated and by 1 AM it was extremely bad. She confirmed the diarrhea was mild the same day as the vaccine and then got worse. She has also had a few heart quivers since this happened nothing constant but occasionally she feels like her heart is trembling. She thinks it was Saturday which would have 27Feb2021 because Friday, the day after the vaccine she was exhausted all day from being sick and maybe from the vaccine also but she thinks it was the next day, Saturday when she started occasionally feeling her heart jumping around a bit. She says occasionally her heart is still quivering for no rhyme or reason, just every once in a while she notices it. She says hopefully if she does take the second shot she will do better. The outcome of the event " few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason" was not recovered, "exhausted all day from being sick" was unknown, while for other events was recovered.
70 2021-03-15 chills, headache, fatigue, sleepiness, fever she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; c... Read more
she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; chills but no temperature; fever; fatigue/exhausted; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN9810, expiry: unknown), intramuscular in the muscle of her right shoulder on 05Feb2021 11:00 at a single dose for covid-19 immunization at a public health department. The patient has no medical history and concomitant medications. The patient is experiencing chills but no temperature on Feb2021, fever on Feb2021, fatigue on Feb2021, nausea, and no energy. She had her first shot last Friday (05Feb2021) and was fine. She stated that yesterday afternoon (11Feb2021), she felt really bad. She called the clinic to see if it was symptoms of Covid. She stated that she was freezing cold, but no temperature registered on 12Feb2021 at 13:00. Her head hurt on 11Feb2021 13:00 and she took Ibuprofen but it never let up, so she took Tylenol. She was sleepy on 11Feb2021 14:00 and was napping so she laid on the couch. The patient was also nauseous on 11Feb2021 14:00 but never threw up. She called the clinic to see if she should get tested for Covid. She stated that since she got up that she is exhausted, felt like she had no energy on 11Feb2021 14:00. The patient wanted to know if she needed to be concerned or if this is something that will run its course. She had to go get blood work at the hospital on Wednesday and that everyone had on masks and she did not think that she was exposed. The patient has no prior vaccinations (within 4 weeks). The outcome of the events feeling cold and feeling of total lack of energy was recovering, head pain and nausea recovered on 11Feb2021 while event sleepy was not recovered. The outcome of the other events was unknown.
70 2021-03-16 body temperature increased 103 temperature, loss of consciousness, low BP. Dizziness.
70 2021-03-16 chills, fever I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chi... Read more
I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chills; nausea; I would throw it up; arm was so bad, it had it's own pulse, a pulse of it's own, I couldn't lift it at all plus the pain was like a tooth ache pain; checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90; my chest was shortness of breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored program. A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 24Feb2021 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included viruses, flus (I have had viruses, flus my whole life), five surgeries, gallbladder removed, and asthma, all from unspecified dates and unspecified if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) on an unspecified date, at the age of 70-years-old and experienced a very sore arm. On an unspecified date in Feb2021 the patient experienced, "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath". The clinical course was reported as follows: "I wanted to call today because I got the Pfizer COVID Vaccine 3 weeks ago, 03Feb2021 it was. After the first dose I had a very sore arm and that was it. It was more sore than normal vaccine, but it was that was all I had. After the second dose I was not aware that I would get sick to the extreme that I did. I found out afterwards that other people have said this, I did not know at the time. I thought I was going to die. I am a 70-year-old woman, I am not young, and I have had viruses, flus my whole life and I got so sick. First, I had over a 103 temperature, it came on suddenly, 12 hours to the minute after I got the vaccine. On top of that I had such bad chills I never saw anything like that in my life, 5 blankets on top of me, sweaters, sweatshirts and the fever was so high. I could not keep the Tylenol down because I had nausea and I would throw it up. So, I could not even get rid of it. Then on top of that my arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all, plus the pain was like a tooth ache pain, it was excruciating. I have had 5 surgeries, my arm hurt worse than all 5 surgeries put together. And I had my gall bladder removed and everything, nothing hurt to this extent. Now also I have asthma, nothing severe but I do have asthma, so I have one of those little oximeters and you put it on your finger and it checks your oxygen level and normally its 98-99, it went down to 91, all night it was 91, my chest was shortness of breath. I was ready to go to the hospital. And I did not know it was going to be that bad." When clarified about the treatment the patient stated that "yes, the Tylenol helped once I could hold it down. The doctor gave me something to stop the vomiting and the nausea. And then I could take the Tylenol and then the Tylenol worked great. But at first, I was so sick I could not hold the Tylenol down in my stomach I would throw it up, that was the problem." When asked about lab work the patient stated that she had not had lab work done since the first vaccine. She stated that she had stayed in the house because she had other health issues and was afraid to come out for 11 months. So she had not gone out to get anything done. The patient stated that she called because if a third dose was needed, she suggested that a smaller dose be given to small people. She stated that she took childrens medicine most of the time because she was tiny. She wanted to know if Pfizer in the future would be making doses for small people and doses for bigger people. Her suggestion was to have a separate booster to go by weight or by gender, men usually did not experience the same. The clinical outcomes of the events "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath" were all recovered/resolved on unspecified dates. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
70 2021-03-16 cough, chills, headache She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/p... Read more
She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume. A 70-years-old female patient received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation . Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections. The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting, swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.
70 2021-03-20 headache, fatigue fatigue; headache; muscle & joint aches; muscle & joint aches; This is a spontaneous report from a c... Read more
fatigue; headache; muscle & joint aches; muscle & joint aches; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (BNT162B2, product: COVID 19, Pfizer- BIONTECH, Solution for injection, Lot number: 9269) via an unspecified route of administration, administered in Arm Left on 06Feb2021 10:30 as single dose for covid-19 immunisation. Medical history included hypertension (controlled) and irritable bowel syndrome. Known allergies was none. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), verapamil, spironolactone (ALDACTONE) and losartan all are via unspecified route from unspecified date at unspecified dose and frequency for unspecified indication. Facility type vaccine: Other, if other vaccine in four weeks, COVID prior vaccination and COVID tested post vaccination reported as no. historical vaccine included first dose of BNT162B2 product: COVID 19, Pfizer- BIONTECH, Lot number: 8982 on 16Jan2021: 02:00 PM unspecified route Left arm for COVID-19 immunization. The patient experienced fatigue, headache, muscle and joint aches on 06Feb2021 14:30. Patient received treatment for AE reported as no. The outcome of the events was resolved on an unspecified date in Feb2021.
70 2021-03-20 fever, chills nausea; low grade fever; chills; 4hrs after shot: redness at injection site; red rash about 3" in di... Read more
nausea; low grade fever; chills; 4hrs after shot: redness at injection site; red rash about 3" in diameter on non vaccinated arm. Rash is not itchy or raised; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unknown route of administration on 11Feb2021 at 16:00 (04:00 PM) in Left arm at single dose for COVID-19 immunisation at Pharmacy or Drug Store. Age at vaccination was 70 years. The patient wasn't pregnant at the time of vaccination. Patient had allergies to medications, food, or other products. Other medical history included asthma. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included fluticasone propionate, salmeterol xinafoate (ADVAIR) at 250/50; lisinopril (LISINOPRIL) at 40 mg dose; salbutamol sulfate (VENTOLIN) Inhaler. The patient experienced redness at injection site 4hrs (at 20:00) after shot on 11Feb2021. On 12Feb2021 at 18:00 (06:00 PM), she experienced nausea, low grade fever, chills 24hrs after shot; on Feb2021 experienced red rash about 3" in diameter on non vaccinated arm 40hrs after shot. Rash was not itchy or raised. Patient didn't received treatment for the adverse event. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Serious was reported as no. Outcome of all events was unknown. No follow-up attempts are possible. No further information is expected.
70 2021-03-22 dehydration, sweating 13 hours after injection while sleeping had strong urge to go to the bathroom, bowel movement, resul... Read more
13 hours after injection while sleeping had strong urge to go to the bathroom, bowel movement, resulting in massive diarrhea. During process, became very dizzy and felt nauseous and faint. Attempting to get up from toilet, and getting assistance from husband in an adjoining bedroom, made it to a second bathroom, passing out, again, complete empty of bowels severe diarrhea again while passed out on floor. Unconscious for about one minute, until revived by husband. Sweating, faint, very low BP. Taken to hospital by husband after getting composure admitted for observation due to apparent dehydration from massive diarrhea event. Results possible cardiac instability, dehydration from diarrhea, vegas nerve activity with Discharge the next day 03/22/2021 with follow up with cardiac Dr and primary, ongoing
70 2021-03-23 fever The vaccine was administered to this patient while in Skilled Nursing Care at this facility for Lumb... Read more
The vaccine was administered to this patient while in Skilled Nursing Care at this facility for Lumbar Spinal Stenosis. Following the injection the patient has experienced intermittent fever of unknown origin, severe skin pain to extremities, and paralysis to both upper and lower extremities. The symptoms are being investigated and the patient remains hospitalized.
70 2021-03-24 fatigue Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She ... Read more
Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot; Fatigue; had a low blood sugar episode she supposed; passed out/Unconsciousness; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; crashed unconscious to the floor/fell/fell backwards/caught her foot under the vanity; This is a spontaneous report from a contactable consumer (patient) reporting for herself A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 20Feb2021 11:00 (Lot Number: EN6201) as a SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation. Medical history included breast cancer from 1988 to an unknown date , ovarian cancer from 2015 to an unknown date , she has had lymph nodes removed from her right arm "30 years ago" from 1988 to an unknown date, pass out from unknown date to unknown date. Concomitant medication included olaparib (LYNPARZA) taken for ovarian cancer from Feb2020 at 150mg, 2 tablets in the morning and 1-2 tablets at night by mouth.She says she is a little person and couldn't tolerate the side effects of that, so she varies how many she takes based on her side effects. She says she is supposed to take 300mg in the morning and 300mg at night. She says how she takes it is, she takes 150mg or one pill in the morning, then one or two at night depending on how she is doing. Historical vaccine information included BNT162B2 dose 1, lot no: EL9264, route left arm for Covid-19 immunisation. Past drug history included on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out. The patient reported approximately 15 hours after the shot, on 21Feb2021 she had muscle spasms almost to seizure amount of shaking, full body muscle spasms. She clarifies that her side effects didn't kick in until 02:30AM on 21Feb2021. She says at 07:00AM on 21Feb2021 she got up and went into the bathroom and passed out, and had a low blood sugar episode she supposed. She crashed unconscious to the floor. She said that could be from the shot, but she is also a high risk patient, a cancer patient, and is on a maintenance chemo drug. She says on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out, so she doesn't know if that was related to the COVID shot or not. No testing had been done on high risk patients, so she thought maybe this could be a good heads up for something someone else may experience. Her side effects were on and off for several hours, the shaking and spasms would subside and then start again. She says that they went away, and then she got up and passed out, and her foot was all messed up, she doesn't know what she did when she fell, but she had it checked and it was not broken, it was all bruised and swollen, but it was not broken. She says this was her right foot. She says she thinks she fell backwards, and she thinks she caught her foot under the vanity. On unknown date, she experienced bruising of foot, fatigue, foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot. Outcome of the events was unknown. Information on the lot/batch number has been requested.
70 2021-03-24 fever, malaise, fatigue, chills I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It wa... Read more
I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It was so bad; that's how bad that was; I woke up with the migraine headache, I never had a migraine; I had complete chills; I had a bad fever; I had complete exhaustion; my whole body hurt; I had complete exhaustion; my whole body hurt; I started vomiting, I had repeated vomiting; I just could not feel any worse; No, I just don't feel great yet, I lost 5 pounds truthfully; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 16Mar2021 (at the age of 70-years-old) as single dose for covid-19 immunization. Medical history included thyroid disorder (thyroid). Concomitant medication included thyroid (NATURE THROID) for thyroid. On 17Mar2021, the patient experienced that she had a horrible reaction to the second shot of COVID 19; she really thought she was going to die; It was so bad; that's how bad that was; the patient woke up with the migraine headache, she never had a migraine; the patient had complete chills; the patient had a bad fever; the patient had complete exhaustion; her whole body hurt; the patient started vomiting, she had repeated vomiting; she just could not feel any worse. The patient stated, "No, I just don't feel great yet, I lost 5 pounds truthfully" and with treatment, the patient stated, "No, just drink water." The patient thought maybe other people were having this, were other people calling that they got that sick and the patient was not obese or anything. The patient know they make it like if they were overweight, terribly overweight, have a worse reaction, the patient was a little overweight but hardly any. The outcome of the events was unknown. Information on the lot/batch number has been requested.
70 2021-03-24 fatigue Patient presented 2 days after injection with bilateral lateral chest pain radiating to back, interm... Read more
Patient presented 2 days after injection with bilateral lateral chest pain radiating to back, intermittent, sometimes at rest and sometimes with walking. Had previously been walking 2 miles twice daily, found extreme fatigue stopped her from walking more than 4 blocks with onset at same time. Evaluation included normal CBC w/ diff, ESR, CRP, CMP, LFTs. With pain no better, further eval 3/12 included RUQ U/S ddimer, NT-ProBNP. US showed dilated IVC and hepatic veins, EKG showed only bradycardia at HR 47. Patient eventually agreed to admission, workup for ACS negative with normal echo, clear coronary angiogram. Continuous monitoring showed severe bradycardia with episodes in 20s, pain improved with nitroglycerine. Pa
70 2021-03-28 sweating RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began havin... Read more
RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began having chest pain radiating down her arm, chest heaviness, right arm numbness, and some shortness of breath. Vitals BP:146/78, O2 94% on room air. Patient also pale and diaphoretic. Taken by ambulance to emergency room. Patient has extensive cardia history per EMT report: has pacemaker, had stress test and scheduled for a cardiac procedure. 3/29/21 Phoned patients daughter to follow up with patient's status. Patient does not have cell phone and speaks Bosnian. During hospital stay, she reports her O2 sats were low, had a heart cath. procedure,
70 2021-04-06 headache, chills 4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, des... Read more
4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, described as unusual pain; thought a migraine was coming on. 5-7:00pm headache continues to worsen; chills; research on line side effects of Pfizer vaccine and they coincide with symptoms; 7:05 gets up to urinate (no assistance needed); screams out in pain 3 times while on toilet; starts to vomit; right side of face (eye and cheek and mouth droop like a stroke; left hand starts to curl. Loses consciousness immediately thereafter. 911 call; paramedics on the way; airway was swept and clear; gurgled breathing. Rushed to Hospital and assessed as having massive brain bleed. Pronounced dead at 10:22pm. Acute Hemorrhagic Stroke on Death Certificate.
70 2021-04-06 dehydration, fever, fatigue, chills, malaise, headache Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, h... Read more
Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, her eyes are weak; Difficulty breathing; thought she was having a heart attack; dehydrated; fast heart beat that felt like her chest was full; fast heart beat that felt like her chest was full; Injection Site Pain; blood pressure fluctuated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (lot number: EN6202; expiration date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure and stroke from 2012 to an unknown date. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for stroke from 2012 and ongoing; clopidogrel bisulfate (CLOPIDA) and simvastatin both taken for high blood pressure from 2012 and ongoing; ongoing amlodipine, lisinopril, and metoprolol all taken for high blood pressure. On 27Feb2021, she took the first vaccine. From that day, for 2 days, she had injection site pain. On 07Mar2021, she started having tiredness, headaches, chills, fever, felt nauseated, had a fast heart beat that felt like her chest was full and thought she was having a heart attack, dizziness, weakness, felt sick, and difficulty breathing. The patient added that she can't see as good, her eyes are weak. She was going to make an appointment to get her eyes checked. For dizziness event, she has to sit on the side of her bed for 10 minutes and she was still dizzy. She has to hold on to something because she feels like she is going to fall. She was given meclizine three times a day for this event. For tiredness event, she stated that it fluctuates during day. After she takes a paracetamol (EXTRA STRENGTH TYLENOL) and lays down for a while, she feels ok and then she feels tired again. For fast heart beat that felt like her chest was full and thought she was having a heart attack event, it comes and goes, she had it yesterday (21Mar2021) but hasn't had it today (22Mar2021) but she doesn't know if it is gone. Her symptoms were usually in the morning when she first gets up. She has been to the emergency room (ER) on 07Mar2021 and on 13Mar2021 and they say that nothing is wrong. On 07Mar2021, they gave her an IV because they thought she was dehydrated. On 13Mar2021, she went back to another hospital ER. She felt worse and her son came and got her and took her to the ER. They did a whole workup MRI of her head, x rays, blood work and everything. They didn't know what was causing it because it had it been over a week since her vaccine and they sent her home. She has been laying down and staying hydrated. She couldn't hardly get up and they asked her what has she done different and the only thing different was the vaccine. Everything listed on the risk factors [side effects] is how she is feeling. She was not hospitalized, they gave her medicine and told her to stay hydrated and sent her home and was told to follow up with her physician. She finally got an appointment for tomorrow (23Mar2021) with her physician. She can't drive because of the dizziness. All of her tests came back normal. They said her blood pressure fluctuated on 2021 but that is normal. Outcome of the injection site pain was recovered on 01Mar2021, of the difficulty breathing was recovering, of the headache, chills, fever, dizziness, weakness, and felt sick was not recovered, while of the remaining events was unknown.
70 2021-04-06 fever excess vomiting about 10 times in 5 hours; Very high fever; This is a spontaneous report from a cont... Read more
excess vomiting about 10 times in 5 hours; Very high fever; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Mar2021 10:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization at a clinic. Medical history included asthma, high blood pressure and allergy with Sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA) and apple cider vinegar. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 at 10:00 in the left arm for covid-19 immunisation. The patient experienced very high fever and excess vomiting about 10 times in 5 hours on 19Mar2021 at 22:00. No treatment was given for the events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
70 2021-04-06 fatigue, runny nose, sneezing, chills fatigue; mild diarrhea; abdominal pain; gas; runny nose; diarrhea with blood; Sneezing; watery eyes;... Read more
fatigue; mild diarrhea; abdominal pain; gas; runny nose; diarrhea with blood; Sneezing; watery eyes; orange bowel movement; near syncope; lightheaded/lightheadness; chills; body aches; decreased appetite/poor appetite; This is a spontaneous report from a contactable Other-HCP (healthcare professional) in response to HCP letter sent in cross reference case. A 70-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EN6201) intramuscularly on 05Mar2021 (at the age of 70-years-old) as a single dose in the deltoid left for COVID-19 immunisation. Medical history included ongoing HTN (hypertension; onset date: years ago; pertinent details: well controlled) from an unspecified date and menopause from an unspecified date and unspecified if ongoing. Concomitant medications included ongoing hydrochlorothiazide orally taken for HTN from an unspecified date, ongoing estradiol benzoate (ESTRADIOL) vaginal taken for menopause from an unspecified date and ongoing multivitamin orally taken for health maintenance from an unspecified date. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EL9261) intramuscularly on 12Feb2021 as a single dose in the deltoid left for COVID-19 immunisation and experienced sore arms and should injury. Prior vaccinations were reported as none. On 07Mar2021 the patient experienced diarrhea with blood (medically significant), sneezing, watery eyes, orange bowel movement, on 06Mar2021 the patient experienced near syncope, lightheaded/lightheadness, chills, body aches and decreased appetite/poor appetite, on 08Mar2021 the patient experienced fatigue, mild diarrhea, abdominal pain, gas and runny nose. It was reported that the event near syncope was non-serious, did not require treatment. It was also reported that the events near syncope and diarrhea with blood required a visit to the emergency room. The clinical course was reported as follows: "05Mar2021 Vax. 06Mar2021- Lightheadedness onset day after COVID vax #2. Lightheaded, chills, body aches, decreased appetite. 07Mar2021- Sneezing, watery eyes, orange bowel movement, poor appetite, diarrhea with blood. To ER. 08Mar2021- Fatigue, poor appetite, mild diarrhea, abdominal pain and gas, sneezing, runny nose. 09Mar2021- Improved." The patient underwent lab tests and procedures on 07Mar2021 that included: EKG, CBC and comprehensive metabolic panel which were all normal. The clinical outcome of the event near syncope was recovered/resolved on an unspecified date while the clinical outcomes of the events diarrhea with blood, lightheaded/lightheadness, chills, body aches, decreased appetite/poor appetite, sneezing, watery eyes, orange bowel movement, fatigue, mild diarrhea, abdominal pain, gas and runny nose were all unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Diarrhea bloody cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
70 2021-04-07 fever fever following vaccination requiring admit to hospital for fever, discharged
70 2021-04-09 headache, chills, fatigue, fever Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had dia... Read more
Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had diarrhea and vomiting (several times in a row).; simultaneously had diarrhea and vomiting (several times in a row).; headache; Slept all day; sore arm; chills; very tired; Fever about 100.5/temp now almost 101; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via unspecified route of administration in left arm on 23Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included prone to bronchitis with bad cold. Known allergies included strong reactions to oxycodone hydrochloride;paracetamol (PERCOCET), zolpidem tartrate (AMBIEN) and some anesthesias. Patient did not have COVID prior vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin, loratadine, ergocalciferol (VIT D) and multi-vitamin. The patient previously received first dose of BNT162B2 (lot number: EN6205) in left arm on 01Mar2021 09:30 AM for COVID-19 immunization. Evening of the shot on 23Mar2021 07:30 PM, patient experienced sore arm, chills, later and very tired. Fever about 100.5. Middle of night, about 16-17 hrs after shot (24Mar2021) awoke with nausea. Rose to go to bathroom and simultaneously had diarrhea and vomiting (several times in a row). Extreme tiredness and nausea. About 4:30 took 2 paracetamol (TYLENOL) and anti-nausea med. Passed out in bed on 24Mar2021. Woke about 11:30 AM. temp now almost 101, headache, paracetamol and more anti-nausea med. Slept all day until 10:45 PM 24Mar2021 fever normal, nausea gone, quite tired still. On 25Mar2021, patient was able to get up, still tired but so much better, stomach still queasy. Ate bit of toast, later, rice and applesauce. Bit of headache took paracetamol. Very difficult to fall asleep that evening (25Mar2021), awoke 26Mar2021 and fell so much better although stomach still a bit queasy. Treatment was received for all events. Patient had not tested COVID post vaccination. The outcome of events was recovering.
70 2021-04-09 sleepiness, headache loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach ... Read more
loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach cramps; slept 15 hours; lump; pimple; infection on the abdomen; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 24Feb2021 (Lot Number: EN6202) as SINGLE DOSE for COVID-19 immunization. Medical history included a lot of allergies from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for high blood pressure, start and stop date were not reported; formoterol fumarate, mometasone furoate (DULERA) taken for bronchial hyperreactivity, start and stop date were not reported; fluticasone to help her breathe, start and stop date were not reported; fexofenadine a decongestant for allergies, start and stop date were not reported; tolnaftate antifungal solution for toenail, start and stop date were not reported; and fluorometholone taken for plugged up tear duct, start and stop date were not reported. The patient previously had flu shot once about 15 years ago and it was terrible. With the first dose, the patient started to have loss of appetite, pretty bad headache, body aches, tightness in her chest, ringing in her ears, and stomach cramps. She slept 15 hours the first night. She got up to go the bathroom and then went right back to bed. That happened after first dose and she wasn't too anxious to get the second dose. These were pretty strong. For 24 hours after onset they were pretty severe. Then she experienced variation of these and lessening of severity over seven days. By the next Wednesday she felt her normal self. She got both shots on Wednesday. She didn't have fever or any other problems that COVID people get. The patient had an infection on the abdomen. She took Cephalexin for 10 days. The infection on the abdomen started in early Mar2021. It was like a lump in Mar2021. She went to the dermatologist because there is cancer in her family. The dermatologist told her not to worry. Then it erupted like a big pimple in Mar2021. The outcome of the events was unknown. Follow-up attempts are needed. Information on lot/batch number is available.
70 2021-04-12 nasal congestion distance vision loss began happening four days after being vaccinated; salivatory glands in mouth dr... Read more
distance vision loss began happening four days after being vaccinated; salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was with in about ten minutes after vaccination was given.; salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was with in about ten minutes after vaccination was given.; The initial spontaneous report information received from a contactable consumer (patient) on 23Mar2021 safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 28Mar2021, this case now contains serious adverse reactions. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EP7534) via an unspecified route of administration to right arm on 22Mar2021 15:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure, lymes disease, dengue fever, artheritis, known allergies: bees, known allergies: mold, botox and known allergies: some meds. Concomitant medications included lisinopril, vitamins nos and ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX). On 22Mar2021 patient reported with salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was within about ten minutes after vaccination was given. Patient took benadryl and was observed for 30 min for the events. On 26Mar2021 20:00 patient experienced with distance vision loss began happening four days after being vaccinated patient did not received any treatment for this event. Outcome of event Vision loss was not recovered and Recovered with sequel for other events. No further information is expected.
70 2021-04-15 fatigue Date and time of vaccination: (list both if they received both shots): 02/02/21 1100, 02/23/21 1200... Read more
Date and time of vaccination: (list both if they received both shots): 02/02/21 1100, 02/23/21 1200 Date and time adverse event started: 02/05/21 1100 SOB AFTER FIRST SHOT ,FATIGUE , WAS ADMITTED TO HOSPITAL FOR 7 DAYS , RELEASED AND THEN RETURNED TO THE HOSPITAL , SENT BACK TO , SAW THE DOCTOR 24TH OF MARCH , DOCTOR ADVISED WATER REDUCTION AND THE PATIENT HAD DEVELOPED CHF , PATIENT PAST ON THE 29TH
70 2021-04-15 fatigue Day of shot #2 (3/31/21) I experienced nausea in the first 15 minutes and felt confused while drivin... Read more
Day of shot #2 (3/31/21) I experienced nausea in the first 15 minutes and felt confused while driving. Nausea passed in 2-3 hours and I felt fine. The next day I felt tired, foggy brain, and dizzy. Assumed it was from the shot. Side effects continued/worsened. 4/6/21 I saw my Dr. She checked me over, labs. found nothing wrong with me. Likely side effects from Pfizer. Unlikely that they would last two weeks. Rx Meclizine for dizziness, which didn't really help. Now it's Day 15. Tired and brain fog are gone. I don't feel as dizzy. BUT, when I try to drive, I feel QUITE dizzy with blurred vision. This side effect persists and clearly effects my quality of life.
70 2021-04-17 fatigue, sweating, headache Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both... Read more
Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both upper and lower parts collapsed); Lower chest partial atelectasis or scarring in the lung bases bilateral; Beneath this area was a red circle where blood clotted or something; Wheezing; Shortness of breath; Swelling of the face; underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red; underneath the arm where the injection site was, a big red circle was noted and it was swollen; I would get hot and cold; I was sweating; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Fatigue; Pain in left elbow; goes to bathroom and bowel was not emptying the way it should; rib cage is going on the side of body noticed this thumping; Her lips were red; Throat was red; Been sick and just laying around; Her eyes were red; Cramp in left arm where site of injection; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; This is a spontaneous report received from contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 15Mar2021 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included lung issues and allergic asthma. Family history included brothers and sisters who died of lung issues and third sibling sister died many years ago due to allergic asthma. The patient previously took flu vaccine for immunization and experienced severe pain throughout her whole body. On 15Mar2021, patient received the first dose of Pfizer COVID-19 vaccine. Later on, that day when she got home after receiving the vaccine, underneath the arm where the injection site was, a big red circle was noted and it was swollen, beneath this area was a red circle where blood clotted or something, she would get hot and cold and take her clothes off because she was sweating but did not have fever, there was pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow. She goes to bathroom and bowel was not emptying the way it should. She also noted that her rib cage is going on the side of body noticed this thumping, lips and throat were red. She's been sick and just laying around, her eyes, under her nose and left elbow were red, had cramp in left arm where site of injection, and sharp pains were hitting her in her eye, thigh, chest, head, and the arm. Patient clarified that these symptoms began on 15Mar2021, the same day she received the Pfizer COVID-19 vaccine. On 23Mar2021, patient went to the ER and the findings were lower chest partial atelectasis or scarring in the lung bases bilateral and partial lung collapse (both upper and lower parts collapsed). At the hospital her temperature was 98.9 F on 23Mar2021, but 97.1F - 97.7F is her normal temperature. She went to the Pulmonary doctor also, but was getting a second opinion because she knew it could be life threatening. The pulmonary doctor made light of it saying they were just creases, like creases in pants. Patient said crease was a far cry from partial lung collapse on both bases and the Pulmonary doctor also said that it is in the upper part of the lung also. This scared her and made her think nobody cared. She did not know if she should provide the information because the doctor did not seem to believe that that her symptoms were coming from receiving the Pfizer COVID-19 vaccine. She guessed she should provide the information because Pfizer does research. She wanted to know how long do the side effects last and if she should take the second dose. The outcome of the events underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red, pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow, goes to bathroom and bowel was not emptying the way it should, rib cage is going on the side of body noticed this thumping, lips were red, throat was red, been sick and just laying around, eyes were red was not recovered; while unknown for the other events. Information on the lot/batch number has been requested.
70 2021-04-17 malaise she ended up in the hospital her blood pressure was way up, it was at 188; pain in chest; feeling si... Read more
she ended up in the hospital her blood pressure was way up, it was at 188; pain in chest; feeling sick and stuff; on her right arm she has a hidden rash between her hand and her elbow; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EP6955), via an unspecified route of administration, administered in the left arm on 22Mar2021 at 16:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EN6198) on 25Feb2021 at 15:00 on the left arm for COVID-19 immunization and reported that her blood pressure went sky high and it continued to be high and her heart rate was up and caused her to go to urgent care. The patient also previously received a flu vaccine on an unspecified date and her arm was sore for 3 weeks and she felt like she had the flu for 3 days. The patient reported that after she got her second vaccine she had the normal, what people call normal reaction, of feeling sick and stuff on 27Mar2021 then she ended up in the hospital her blood pressure was way up, it was at 188 and she forgets what the bottom number was. She went in because she felt like she was having a heart attack there was a pain in chest like right where the middle of a bra would be. It lasted about 15 or 20 minutes. That is her experience with the vaccine, it is raised blood pressure and she is still dealing with it her blood pressure is still high. She tries not to be scared but the doctors at the hospital made her a little nervous that is why she spent the night but that is a definite side effect. The patient was admitted to the hospital on 27Mar2021 and was discharged on 28Mar2021. They wanted to keep her for 2 nights and do a stress test and she said no way she is not staying for 3 nights in that hospital, the nurses were outstanding they were the most efficient nurses but the hospital food sucked and she got no sleep. Also, on her right arm she has a hidden rash between her hand and her elbow under the skin there is a rash that popped up with the vaccine on an unspecified date in Mar2021. The patient also stated that her blood type is O negative and she does not know she heard that O neg people weren't going to get COVID and she has never got COVID before. The patient also reported that they drew blood 6 times in the hospital to see if she had a heart attack and everything came back negative. it just so happens she had a echocardiogram the day after the first dose was given and her blood pressure was elevated that day but everything was fine. She says it is not relevant but she tested for that out of precaution, her doctor asked her to do that every 2 years and just so happened to fall on the day after the first dose. The patient received treatment for the events she ended up in the hospital her blood pressure was way up, it was at 188, felt like she was having a heart attack and pain in chest. The outcome of the event she ended up in the hospital her blood pressure was way up, it was at 188 was not recovered while the outcome of the other events was unknown.
70 2021-04-20 fever, chills lungs feel congested; Chest tightness; chills; fever; inflammation; This is a spontaneous report fro... Read more
lungs feel congested; Chest tightness; chills; fever; inflammation; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Right arm on 03Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Asthma, hypertension, covid prior vaccination. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); montelukast sodium (SINGULAIR); losartan; HCTZ; unspecified product "D". The patient previously took erythromycin and experienced allergy. The patient received the first dose of bnt162b2, at the age of 70-year-old, via an unspecified route of administration, administered in right arm on 13Mar2021 11:00 as single dose for covid-19 immunization and experienced fatigue and sore arm. The patient experienced lungs feel congested, chest tightness on 04Apr2021 03:00; chills, fever and inflammation on 03Apr2021. Chills and fever Sat. night into Sunday, fever lasted until Monday 05Apr. Chest tightness, lungs feel congested. Went to doctor, he thought inflammation from vaccine. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The patient was not pregnant. The outcome of the events Fever was recovered on 05Apr2021, other events was recovering. Information on lot/batch number has been requested.
70 2021-04-24 fatigue My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; V... Read more
My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; Very weak and tired; This is a spontaneous report from a contactable consumer (reporting for herself). This 70-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration on left arm at a single dose on 04Feb2021 09:45 AM, for Covid-19 immunization. She Received second dose BNT162B2 (Pfizer Covid 19 vaccination, lot number EN6200) via an unspecified route of administration, on left arm at an single dose on 25Mar2021 for Covid-19 immunization. She was not pregnant at the time of vaccination. She had not received any other vaccine in four weeks. Medical history included type II diabetes, high blood pressure and pneumoconiosis. She was allergic to Chlorol Hydrate and Thimerasol. Concomitant medications included Metformin, Losartan HCTZ, Amlodipine, Zyrtec. On 09Mar2021 07:00 AM, the patient experienced a rash above her right knee, up my thigh, and knee pit, felt very weak and tired, her entire body experienced extremely severe body pain from upper neck down to feet. It got so bad that she could not walk, only took baby steps. It was stated that she would cry with hand on the wall with each baby step. On 12Mar2021, the patient went to the hospital emergency room and the patient was tested for Covid-19, blood test came out to be negative, results of SARS CoV-2, diagnostic radiologic EC EKG were unknown. She was treated with intravenous and pain medication. The outcome of the events of rash, felt very weak and tired, extremely severe body pain and could not walk was recovering. No follow-up attempts are needed. No further information is expected.
70 2021-04-28 headache Having headaches every day since this has happened; Had TIA (memory loss); Have no memory of 24 hour... Read more
Having headaches every day since this has happened; Had TIA (memory loss); Have no memory of 24 hours, could not answer any questions had lost memory; This is a spontaneous report from a contactable consumer (patent). A 70-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 04Mar2021 09:45; at the age of 70-years-old, (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient received the first dose of bnt162b2 on 02Feb2021. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. No Covid tested post vaccination performed. The patient experienced Transient ischaemic attack (TIA) on 13Mar2021 and was admitted to hospital, she could not answer to any questions and had lost memory. The patient had no memory of 24 hours, could not answer any questions had lost memory. She also complained headaches every day since this has happened (as reported). The reported events were headache (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae, Transient ischaemic attack (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae, Amnesia (have no memory of 24 hours), (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae. Information on the lot/batch number has been requested.
71 2021-01-05 chills Abdominal pain, chills, n/v, dark urine, elevated LFT's, Bilirubin in urine. Patient currently admit... Read more
Abdominal pain, chills, n/v, dark urine, elevated LFT's, Bilirubin in urine. Patient currently admitted to hospital
71 2021-01-06 headache Headache began morning after vaccine was received. Improves with tylenol. Still having intermitten... Read more
Headache began morning after vaccine was received. Improves with tylenol. Still having intermittent headaches. Has followed up with her PCP.
71 2021-01-07 headache Mild headache Mild body aches
71 2021-01-09 headache Three itchy vesicular lesions on upper left three days after vaccine lasting three days thus far. H... Read more
Three itchy vesicular lesions on upper left three days after vaccine lasting three days thus far. Headache first twenty four hours. Tylenol, Neosporin ointment, Cortisone cream, Anti-itch cream
71 2021-01-10 fatigue Chest tightness, body aches, fatigue
71 2021-01-12 cough Bad cough and explosive diahrea
71 2021-01-13 chills, sweating, fever I woke in the middle of the night feeling achy and took a Tylenol. Felt feverish all day and took t... Read more
I woke in the middle of the night feeling achy and took a Tylenol. Felt feverish all day and took two more doses of Tylenol. Feverish enough that I stayed in bed all day. No headache next day still a feverish with chills but seem to sweat little and t goes away. Much better the third day.
71 2021-01-13 fatigue Patient presented to the COVID clinic today January 14, 2020 for her first COVID-19 vaccine. She wa... Read more
Patient presented to the COVID clinic today January 14, 2020 for her first COVID-19 vaccine. She was given 0.3 mls of the vaccine IM in the left deltoid.at 2:40 pm. She pulled around to the observation area and at 2:45 she reported that she was experiencing her lips tingling along with chest pressure and SOB. Spo2 was 96% on RA. Oxygen applied via face mask at 4 L.. Sp02 then went up to 99%. At 2:50 BP was 122/80. At this time she reports that the chest pressure has subsided but that she was still experiencing some fuzziness in her eyes. She denies any itching. At 2:53 she reports that her lips are not as numb but that she still has some fizziness. At 2:58 she reports that she feels "real tired" and that she is not as "fuzzy headed". Patient continued to improve. At 3:09 oxygen was removed. Sp02 stayed at 98%. After observing patient for several minutes she was found to be in stable condition to leave the observation unit. She was agreeable to this plan. She will notify her PCP with any further symptoms.
71 2021-01-14 chills, headache Headache, vomiting, chills, dizziness 24 hour bed rest and Tylenol 1/15/2021, still light headed and... Read more
Headache, vomiting, chills, dizziness 24 hour bed rest and Tylenol 1/15/2021, still light headed and slightly dizzy
71 2021-01-14 fatigue Sore arm, fatigue
71 2021-01-14 throat pain Sore throat swollen lymph nodes on neck
71 2021-01-14 chills chills; stomach cramps; watery diarrhea all day and through the evening; This is a spontaneous repor... Read more
chills; stomach cramps; watery diarrhea all day and through the evening; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EK9231 and expiry date unknown) via an unspecified route of administration in the left arm on 07Jan2021, 12:15PM at a single dose for COVID-19 immunization. The patient's medical history included allergy to scallops. Concomitant medications included metoprolol, omeprazole, simvastatin, magnesium chloride (SLOW MAG), and colecalciferol (VITAMIN D); patient also receive these medications within 2 weeks of vaccination. The patient had previous allergies with Erythromycin. The patient was not pregnant; did not receive any other vaccines within 4 weeks prior to BNT162B2; and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On Sunday, 10Jan2021, 1200AM, reported as three days after vaccine, the patient developed chills, stomach cramps, and watery diarrhea all day and through the evening. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
71 2021-01-15 malaise 1/15/2021, 8:15 AM Approx. 10 minutes after arising, experienced dizziness, nausea, unwell feeling,... Read more
1/15/2021, 8:15 AM Approx. 10 minutes after arising, experienced dizziness, nausea, unwell feeling, cold sweat. Lasted approx. 20 minutes. Resolved after lying down..
71 2021-01-16 chills, headache injection site redness and soreness, severe migraine headache, severe myalgia (even the tendons in m... Read more
injection site redness and soreness, severe migraine headache, severe myalgia (even the tendons in my hands and feet hurt), arthralgia, chills, rigors, swollen lymph nodes lasted two and a half days, mostly spent in bed
71 2021-01-17 fever Patient received vaccination at 6:30PM and honked horn from parking lot at 6:45 PM. Patient appeared... Read more
Patient received vaccination at 6:30PM and honked horn from parking lot at 6:45 PM. Patient appeared to be short of breath, 911 called at 6:46 PM and EMS on scene at 6:48 PM. At this time, patient was short of breath and "lightheaded." Respirations, oxygen saturation, and heart rate were WNL. BP was elevated (200/110). After evaluation by EMS, patient was encouraged to go to hospital (though patient was not in acute distress per EMS team). Patient declined but said she would wait in parking lot for longer. At 7:15PM, patient honked horn again and said she still felt lightheaded and like she "had a fever." Patient agreed to be transferred to hospital for further evaluation, though she did not seem to be in respiratory distress at this time. Pt transferred to hospital by EMS team at 7:25 PM.
71 2021-01-17 fatigue, malaise, sleepiness, influenza like illness Qualifier: I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm ... Read more
Qualifier: I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm on 1/12/21. When I woke up on 1/13/21, I was very sick. I felt like I had a severe, very bad, horrible flu. I didn't get out of bed until 5pm that evening. No fever. No body or joint aches. Just extreme, overwhelming fatigue and feeling flu-y. This phase lasted about 24 hours. (my right am also hurt, but that was minor) I have a severe case of Sjogrens, a systemic autoimmune disorder. My most debilitating Sjogrens symptom is overwhelming fatigue. If I weren't retired, I would be qualified as disabled. Handicapped tag, etc. Since the vaccination, my Sjogrens has "flared." I feel terrible, exhausted, can't do anything. I have cancelled everything. All I can do is sleep, and feed the cat. I am directly connecting this Sjogrens flare to the vaccine. When I'm in a flare this bad, I usually take a course of prednisone. I have not done this because I don't want to modulate my immune system while it is building covid antibodies. I can't wait for the 2nd vaccine on 2/2/21!
71 2021-01-19 fever NECK AND BACK ACHE IN THE MORNING (1/19). FEVER 98.9. TOOK TYLENOL
71 2021-01-19 fatigue Vomiting , diareeah, nauaea. lots of sinus drainage. overall tiredness. lasted a day . feeling bet... Read more
Vomiting , diareeah, nauaea. lots of sinus drainage. overall tiredness. lasted a day . feeling better but not 100%.
71 2021-01-20 fever, fatigue, headache, fever, chills, chills, fatigue, headache 1/20/21 HA, fever, chills, fatigue, pain and swelling at site, nausea and diarrhea
71 2021-01-20 fatigue Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day a... Read more
Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day after vaccine; fatigue and weakness on day 2 after.
71 2021-01-20 body temperature increased, fever, headache, fatigue, chills REC'D VACCINE ON 1-19-20. ON 1-20-21, STARTED WITH FEVER AND CHILLS. TEMP 101.1. TOOK TYLENOL. HAD S... Read more
REC'D VACCINE ON 1-19-20. ON 1-20-21, STARTED WITH FEVER AND CHILLS. TEMP 101.1. TOOK TYLENOL. HAD SORENESS AT IJECTION SIT, ALL OVER BODY ACHES AND JOINT DISCOMFORT. HEADACHE, SHIVERING, FATIGUE. ON 1-21-21, PATIENT STATES SHE HAS BEGUN TO FEEL BETTER. TEMP 98.8. STILL ACHY
71 2021-01-20 chills, headache couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a ... Read more
couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 10Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving her Covid19 vaccine on Sunday 10Jan2021, reports feeling "heavy", chills, and a headache on Sunday 10Jan2021. On 11Jan2021 Monday afternoon she reports that she "couldn't remember the 4-digit passcode to my phone" or her address, but that her memory came back "in a second". The event couldn't remember passcode for the phone or her address was reported as recovered and unknown for the other events. Information on the Lot/Batch number has been requested
71 2021-01-21 headache, fatigue Headache Shortness of breath achiness tired
71 2021-01-21 fatigue, lethargy, headache Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. ... Read more
Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. Stomach was queasy. Unable to drink coffee. Tried to push fluids and tried to just eat bland foods. Would wake up sporadically but was unable to awaken enough to watch an entire TV show. Pretty lethargic and brain fog. Was able to wake up a little more on Wed 1/20 but still had the queasy stomach. Started getting Headache and Eye pain and severe upper leg and lower back burning & cramping, I tried taking tylenol which helped a little. By Thursday the pain was worse. I was still tired only walking helped the pain. It got worse if I sat down and extremely bad if I laid down to try to sleep. It's Friday morning & I am planning to go to med check this AM. Symptoms still ongoing
71 2021-01-23 headache, fever Headache, Body aches, low grade temp.
71 2021-01-24 headache After receiving the first shot on Monday, I developed a headache and double vision on Tuesday night... Read more
After receiving the first shot on Monday, I developed a headache and double vision on Tuesday night. I consulted an ophthalmologist and I am awaiting the scheduling of an MRI. He could find no physical problem with either eye. The double vision persists. I realize this may be purely coincidental and unrelated to the vaccine, but I felt I should report it.
71 2021-01-24 malaise, fatigue, chills Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: fa... Read more
Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: face swollen, blotchy, numb eyes swollen, sore sockets, upper lip puffed out, burning face feel, asthma
71 2021-01-24 fever, fatigue, headache Extremely unusual pain at injection site, (compared to any other past injections) generally achey, ... Read more
Extremely unusual pain at injection site, (compared to any other past injections) generally achey, headache, occasional waves of nausea, fever 100.4, fatigue (stayed in bed most of the day). There was one occasion where my left hand had a strange involuntary "twitch". I only mention that because on Saturday (1/23/21) i had a few episodes of speech difficulty (words "not coming out right")
71 2021-01-24 chills, fatigue, headache, body temperature increased Muscle in lower area of throat started to feel slightly tight. Could still breath and swallow. Sever... Read more
Muscle in lower area of throat started to feel slightly tight. Could still breath and swallow. Several staff members checked on me. Blood pressure top number was 175, ten minutes later it dropped to 155. Staff member stated my pulse was elevated. Although, I only felt the slight tightness in my throat. My oxygen level stayed at 98. They had me stay for an hour and then I went home. By then the tightness started to lessen. After an hour or two the feeling was total gone. My blood pressure had gone back to normal when I checked it at home. The next day at 2 pm [13 hours later] I had a temperature of 99.1, had the chills yet felt warm, started a slight headache and became very tired. At 2 am in the morning everything was over. I woke at my normal time and felt great. Have been doing well ever since.
71 2021-01-25 headache, fatigue I am experiencing symptoms similar to that when I had Covid in October,2020. My head is aching, sin... Read more
I am experiencing symptoms similar to that when I had Covid in October,2020. My head is aching, sinuses aching and ears aching. I?m extremely tired but the pain keeps me from sleeping much.
71 2021-01-25 fever Nausea, low grade fever, oxygen fluctuating- dropping in 60s. She normally takes oxygen only at ni... Read more
Nausea, low grade fever, oxygen fluctuating- dropping in 60s. She normally takes oxygen only at night at 1L/hour. She went home from work today and placed her oxygen on at 1 L/hour, increased her prednisone to 20 mg daily from 10 mg daily and performed ipatroprium nebs three times daily.
71 2021-01-25 headache persistent headache; even touching her head hurts/hurts to the touch; with this shot her arm really ... Read more
persistent headache; even touching her head hurts/hurts to the touch; with this shot her arm really hurt when getting it/pain in the arm the shot was given/uncomfortable pain/in their arm after receiving the injection; insist on giving the next dose in 4 weeks; insist on giving the next dose in 4 weeks; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1283) via an unspecified route of administration in the left upper arm on 06Jan2021 09:40 at a single dose as COVID vaccine. The patient had no medical history. Concomitant medications noted as on other medications but nothing new. She previously got the shingle shot for immunization then her arm hurt a few days. She had no other reaction to vaccines in the past. She received no vaccine on the day of or in the prior 4 weeks. Last Wednesday on 06Jan2021, the patient took the vaccine and has had a headache since; even touching her head hurts. She had a persistent headache that started the day after the vaccine and has continued since. The next day on 07Jan2021 was when the headache started. She took regular Motrin (lot OFE3249A, expiry: May2022) and Tylenol extra strength (lot: LMA051, expiry: Jul2019, perhaps not working anymore) sometimes but they didn't really seem to help. She felt the best when she was standing up or laying down, and she would rather be laying down. She asked "Is this a normal side effect, am I dying? I am not a headache kind of person, I take a Motrin, it goes away and I do not have one for months. It actually hurts to the touch." Should she be worried? She did call the clinic about the headache and was told if it got serious to go to the emergency room, she didn't think it was that serious. It was just persistent. She could leave with the pain if it kept her from getting COVID but the fact it was persistent worried her. It was also reported that on 06Jan2021 with this shot her arm really hurt when getting it and that day but that was all (pain in the arm the shot was given), the next night there was no pain. Her and her husband both oooo'd and ahhhh'd with the pain in the arm but that was it (a very uncomfortable pain they experienced in their arm after receiving the injection). She asked how long a side effect lasts after the vaccine? She also stated that on Jan2021, they insist on giving the next dose in 4 weeks. Asked if the vaccine was given a week later would the efficacy be lower? The outcome of persistent headache was not recovered; of vaccination site pain was recovered on 07Jan2021; and of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021036651 same reporter and drug, different patient and AE
71 2021-01-26 fatigue, nasal congestion, throat pain, fever Mild fever, nausea headache, extreme fatigue, muscle ache, stuffy nose, sore throat, sore arm
71 2021-01-26 chills, sweating, malaise Nausea; Chills; Sweating; General unwell feeling; This is a spontaneous report from a contactable co... Read more
Nausea; Chills; Sweating; General unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at the right arm on 11Jan2021 13:45 at a single dose for covid-19 immunization. Medical history included allergic to shellfish and allergic reaction to bee sting 50 years ago. Concomitant medication included losartan potassium (strength: 100 mg) and atorvastatin calcium (ATORVA). The patient experienced nausea, chills, sweating and general unwell feeling on 13Jan2021 12:15. The patient took two paracetamol (TYLENOL) as treatment for the events. The patient was not pregnant at the time of administration. Outcome of events was recovering.
71 2021-01-27 malaise, body temperature increased, chills Chills began at 11:15p, by morning 1/27/2021 I had a fever of 101.1. Stiffness in joints, couldn't w... Read more
Chills began at 11:15p, by morning 1/27/2021 I had a fever of 101.1. Stiffness in joints, couldn't walk without losing balance in early a.m. No appetite. Vomited in early afternoon. Just a very sick feeling. Began feeling better during evening. Was just able to tolerate drinking water. Today (1/28)temp is 98.1. Feeling better, just a little weak.
71 2021-01-27 fever FEVER AND BODY ACHES = 1 DAY
71 2021-01-27 influenza like illness Flu like symptoms; feeling achy; Left arm sore after second dose injection administered initially de... Read more
Flu like symptoms; feeling achy; Left arm sore after second dose injection administered initially described as at the injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second single dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, lot number: EK9231, exp date: Apr2021), via an unspecified route of administration (Injection to left upper arm ) on 13Jan2021 09:00 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first single dose of BNT162B2 (lot number: EK5730) on 23Dec2020 for COVID-19 immunization wherein she reported left arm sore after first dose injection administered which she recovered completely from after about 4 days (from 23Dec2020 to 27Dec2020). The patient called to ask if it was ok to take something like Ibuprofen or paracetamol (TYLENOL) after having been administered Pfizer COVID-19 Vaccine. She reported left arm sore after second dose injection administered on 13Jan2021 and flu like symptoms on an unspecified date. The left arm sore after first dose injection administered was same reaction she had following the second dose: Left arm sore after second dose injection administered initially described as at the injection site; very sore; her arm being much better since she slept all last night with ice pack on her left arm; but then specified that outcome of that event and flu like symptoms have remained persistent with on and off pattern; The flu like symptoms include feeling achy which started on 14Jan2021 (day of reporting). The outcome of events was not recovered.
71 2021-01-27 fever, headache Headache - still continuing; Felt fever - like - for 3 days; This is a spontaneous report from a con... Read more
Headache - still continuing; Felt fever - like - for 3 days; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (lot number: EL3246) via an unspecified route of administration on 11Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included controlled diabetes. The patient was allergic to Penicillin. Concomitant medication included metformin, atorvastatin (LIPITOR), lisinopril, and Multivitamin. On 11Jan2021, the patient experienced headache - still continuing, this is the 5th day after the vaccination. On 11Jan2021, the patient also had felt fever - like - for 3 days. The patient received Advil as treatment. The patient is not pregnant. Events outcome was not recovered.
71 2021-01-27 headache Right arm killing her through the night; Little Achy; Headache; This is a spontaneous report from a ... Read more
Right arm killing her through the night; Little Achy; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (BNT162B2 also reported as Pfizer COVID Vaccine, lot EL3247), intramuscular in the right arm on 13Jan2021 18:00 at SINGLE DOSE for Covid-19 immunisation (reported as prevention for age group). She received the vaccine in a hospital. Medical history included a Covid-19 patient on Mar2020, hypothyroidism and normally had headaches. No other vaccines taken prior to vaccination. There were no concomitant medications. On 13Jan2021 03:00, she had arm pain that was killing her through the night. She was a little achy, had a headache, but no fever. The outcome of events was recovering.
71 2021-01-27 headache tenderness on the left arm where she received the vaccine dose.; severe pain in right shoulder joint... Read more
tenderness on the left arm where she received the vaccine dose.; severe pain in right shoulder joint and right hip joint/It was so severe she could hardly get out of bed; Headache; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686, expiration date unspecified), via an unspecified route of administration on 31Dec2020 11:00 at single dose (left arm) for COVID-19 immunization. Medical history included arm soreness from flu shot 2-3 months ago. There were no concomitant medications. It was reported that she received her 1st dose of the vaccine on her left arm on 31Dec2020 as she works with elderly at nursing home and she was of age. Two days after her shot, on 02Jan2021, she experienced little headache which lasted all day but was gone by the following day. On 12Jan2021, 2 days ago, when she woke up and got of bed with severe pain in right shoulder joint and right hip joint which lasted for maybe 10 minutes. It was so severe she could hardly get out of bed. Currently, she had no joint pain. The right shoulder and right hip pain were so odd she thought, but it has also improved since. It's been 2 weeks and she never had this happen before. This lasted a little while, but thought it was from the cold weather since it's been 2 weeks since having the vaccine. She still has a bit of tenderness on the left arm where she received the vaccine dose on an unspecified date. She mentioned this to her supervisor and was encouraged to call and she wants to know if this could be a side effect. The patient had no vaccines the same day or 4 weeks prior. She had the flu shot before in past and the area would be sore for a few days, but now with this Covid vaccine this arm was still tender. Also, she had gotten the shingles shot the same day as the flu shot but that was about 2-3 months ago, at least 2 months ago. The patient had no additional vaccines administered on same date of the Covid vaccine. The patient had no prior vaccinations within 4 weeks prior to the first administration. Outcome of event headache was recovered on 03Jan2021; severe pain in right shoulder joint and right hip joint/it was so severe she could hardly get out of bed was recovered in Jan2021; and outcome of tenderness on the left arm where she received the vaccine dose was not recovered.
71 2021-01-28 fever, headache, fatigue, chills fever, chills, headache, muscle spasms, difficulty walking across the room, dizziness, fatigue, bra... Read more
fever, chills, headache, muscle spasms, difficulty walking across the room, dizziness, fatigue, brain fog
71 2021-01-28 headache severe headache, rash on arms, face,neckline, throat, and hands
71 2021-01-28 throat pain sore throat ear ache
71 2021-01-29 chills, fatigue, fever 11 hours after injection SHAKING CHILLS, teeth chattering to the extreme. 101.5 fever throughout the... Read more
11 hours after injection SHAKING CHILLS, teeth chattering to the extreme. 101.5 fever throughout the night. Fatigue
71 2021-01-29 fever, fatigue FEVER, FATIGUE AND DIARHEA I TOOK TYLENOL AND RESTED FOR 36 HOURS FEVER AND FATIGUE BOTH WENT AWAY ... Read more
FEVER, FATIGUE AND DIARHEA I TOOK TYLENOL AND RESTED FOR 36 HOURS FEVER AND FATIGUE BOTH WENT AWAY STILL HAVE MINOR DIARHEA OCCASIONALLY
71 2021-01-29 fever, fatigue The day after vaccination, I was extremely tired and had a low-grade fever (99.1 F). My muscles ach... Read more
The day after vaccination, I was extremely tired and had a low-grade fever (99.1 F). My muscles ached all over. I could not get out of bed until 5:00 pm. After that, I was able to do my chores (laundry and washing dishes). I was fine the following day.
71 2021-01-30 fatigue, lethargy, chills This was my second dose. After the first dose, I only had a sore arm. This time, about 12 hours afte... Read more
This was my second dose. After the first dose, I only had a sore arm. This time, about 12 hours after receiving the shot, I began to feel aches and pains (like a cold was coming on). During the night I had some chills and the next day I was very achy and very tired. I napped about 4 hours during the day and was asleep by 8p.m. and slept for 12 hours. The next day (second day after the shot), the aches receded but I was still very lethargic for about another 8 hours. I began to feel 'normal' by evening and am felling OK today (third day after the shot). I did drink a lot of water during the whole time as I felt very thirsty (and I am normally a big water drinker!) I also had no appetite until this morning.
71 2021-01-30 fatigue, headache Very fluish- aches, pains, very bad headache, couldn't get out of bed for 36 hours. After 48 hours ... Read more
Very fluish- aches, pains, very bad headache, couldn't get out of bed for 36 hours. After 48 hours I am just very tired and having sporadic shooting pains in my head.
71 2021-01-31 sleepiness Client stated, "I feel very sleepy." Spouse reported hat client was lightheaded and dizzy. Fire Re... Read more
Client stated, "I feel very sleepy." Spouse reported hat client was lightheaded and dizzy. Fire Rescue attended to client on site. Released home with her spouse awake, alert and verbally responsive.
71 2021-01-31 malaise, fatigue, sneezing dizzyish or light headed; didn't feel good/she felt crappy; Sneezing; a little tired/she felt more t... Read more
dizzyish or light headed; didn't feel good/she felt crappy; Sneezing; a little tired/she felt more tired/very, very tired; This is a spontaneous report from a contactable Nurse (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EL0142) via an unspecified route of administration on to left deltoid on 12Jan2021 at a single dose for covid-19 immunization. The patient said her asthma was very mild, she rarely got sick, she did not know if it would flare if she had COVID, it was diagnosed in childhood. She said she hardly ever had to use her inhaler. Besides, she took a blood pressure medication, but her blood pressure was not high, it was very well controlled, it was not horribly high, she took the medication to keep it down. She said this was diagnosed 5-7 years ago. She did not have diabetes or any ongoing issues. She said she had no other recent vaccinations and has started no new medications. The patient said her side effects that started Thursday and she didn't feel good, she was sneezing, she didn't feel herself, and felt off. She said that there was nothing bad, she was a little tired. She said Friday was worse, she felt more tired, and dizzyish or light headed. She said she was very, very tired, but she never had arm soreness, never horribly sore, not much, she never had any other aches or pains, no fever. She said Friday she didn't feel good at all, she felt crappy, and she took care of her father who is 104, so she can't take a day off. She said that on Saturday she felt ok, she didn't feel great, but nothing ever got to the point she was incapacitated. She said on Sunday she felt better, not 100%, her nose was not as stuffy. She said today she felt pretty good or close to normal, she was still dizzy, but not like the room spins. She said she felt mostly better, and had a lot more energy today, she was not as exhausted. She said that she felt so much better than she was feeling, she was getting better, she was worried when she took second shot. She initially said she did not do treatment for her side effects, then said she took some things since she knew about herself, and when she felt run down, and she didn't think she has had a cold in 2-3 years, she didn't get sick often. She said for her body she knows when she felt run down with aches and pains to certain parts of her body that she didn't feel well, then she might be getting sick/rundown. The patient took Tylenol or Advil for it when she felt more uncomfortable. For Advil (LOT: R77223, EXP: Sep2022), she said she took 200mg, two by mouth as needed, she only took 4 in a 24-hour period. She said if she took it or anytime she took anything, if she took Advil it would be 8-10 hours later, and if she took Tylenol the same day, she never took anything every four hours. For Tylenol (LOT SEA054, EXP Mar2024), she said the Tylenol are 325mg each tablet, so she 650mg when she took this because she took two of them. She said she let 8 hours go between doses, if she felt she needed something again, like if she was not comfortable. She said she didn't feel this where the achy places she aches, she also took when she went to bed at night if she needed to, but she was completely functional and not laying around in bed. She said she got her first dose on 12Jan, and she was supposed to get her second dose on the 02Feb. The patient said she felt it was not serious, but she was concerned about getting the second dose. The patient said her labs are normal, she was scheduled for some the same day as the next time she got the shot, when she was supposed to get labs. The patient said that she called because the side effects usually are supposed to be closer to injection date, it was 72 hours post, and the first couple of days there was nothing. She said she would like an opinion of whether someone thought it was ok to get a second shot. The outcome of the events recovering.
71 2021-01-31 fever, headache, malaise nauseous; threw up all day; heart races a little bit in the middle of the night/her heart also went ... Read more
nauseous; threw up all day; heart races a little bit in the middle of the night/her heart also went racing a few times in the night; sinus pain; dizziness/like she was not dizzy today like she was yesterday, but today she was just more like lightheaded; Low grade fever; feeling sick/doesn't feel good; head hurts really bad/terrible headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EH9899, expiration date Mar2021) via an unspecified route of administration on 09Jan2021 at a 0.3mL via injection into the left arm for covid-19 immunization. The patient stated that she had Type 2 diabetes which diagnosed about 10 years ago and high blood pressure diagnosed about 20 years ago, so her providers office sent her a text saying the doctor wanted her to have the vaccine. She confirmed that she had no other vaccines on the same day as the COVID vaccine. The patient stated that she had high cholesterol about 5 years ago and her doctor initially put her on Lipitor, but she got to a point where she could not walk, so her doctor put her on something else, but she could not tolerate that either, so then she was switched to the Pitavastatin Calcium. The patient stated that she also had a very sensitive stomach, but she cannot think of the name of what she was diagnosed with because since she had her a couple of seizures started about two years ago this upcoming Aug, she can't think straight. The patient also had GERD about 5 years ago, macular degenerative disease a couple of months ago. All medical condition was still ongoing. Current concomitant medications included levetiracetam (KEPPRA, Tablet) 500mg, once daily, by mouth started from about two years ago, this upcoming Aug for seizures; metformin 1000mg, two tablets daily, by mouth started from about 10 years ago for Type 2 diabetes; allopurinol Tablet 300mg, once daily, by mouth started from probably 2 or 3 years ago for her kidney; metoprolol tartrate (LOPRESSOR, Tablet) 50mg, once daily, by mouth started from 2 years ago for high blood pressure; empagliflozin (Jardiance, Tablet) 25mg, once daily, by mouth has been on this product about 6 months for Type 2 diabetes; lisinopril Tablet 40mg, once daily, by mouth started from probably about 10 years ago for high blood pressure; diltiazem hydrochloride (CARDIZEM CD, 24 hour Capsule) 180mg, once daily, by mouth started from a couple years ago; omeprazole magnesium (Prilosec, Capsule) 20mg, once daily, by mouth started from probably about 4 years ago for GERD; hydrochlorothiazide Tablet 25mg, once daily, by mouth started probably about 10 years ago for high blood pressure; Vitamin D 125mcg or 5000unit Tablet, once daily, by mouth as Vitamin supplementation started taking this about a year ago. The patient had a blood test where her Vitamin D was a little low. Vitamin C was got it over the counter; PreserVision OTC medication, with Vitamin A, E, C, zinc and copper Two capsules by mouth daily started from about two months ago for macular degenerative disease; pitavastatin calcium Tablet 2mg, once nightly, by mouth for High cholesterol; it was on it before, but started back on it a couple months ago. The patient reported she doesn't feel good and got headache on 11Jan2021, had dizziness and low grade fever on 15Jan2021, had nausea and threw up, sinus pain and heart races a little bit on 17Jan2021. She did not want to go through this again. The patient stated that she had the first shot of the Pfizer COVID Vaccine on 09Jan2021. She felt for a day and a half by Monday, 11Jan2021, she has been sick ever since, she did not feel good at all. She had a terrible headache, and for probably one or two days, she ran a low-grade fever. Her headache was still ongoing, but it had eased up because she was taking Tylenol. The patient stated that the dizziness she had, caused her to be nauseous and she threw up all day yesterday. She tried to eat something today and she was just having bad problems with feeling sick all the time. She asked if there are recommendations for getting the second shot after having symptoms like this. Today is the third day that she had been feeling the dizziness and it had improved a little, like she was not dizzy today like she was yesterday, but today she was just more like lightheaded. The patient reported that the nausea was ongoing, she felt like she was going to get like today like she did yesterday. She did not think she still has a low grade fever, she probably had the low grade fever on 15 and 16Jan2021. She just can't seem to shake not feeling good. At first that it was her sinuses because that was where her head was hurting, but then the sinus pain went away but she still had a headache. The patient stated that her heart also went racing a few times in the night. Yesterday was a bad day, but today she was a little bit lightheaded. She tried to eat some toast today, so she will see if she can keep that down. The outcome of the events headache, dizziness, heart rate increased and sinus pain was recovering and the low grade fever was recovered on 17Jan2021 and other events was not recovered.
71 2021-02-02 headache, fever The next day I woke up with severe muscular pain and joint pain, fever of 100 degrees, dizziness, he... Read more
The next day I woke up with severe muscular pain and joint pain, fever of 100 degrees, dizziness, headache, appetite loss. Took 2 Tylenol and it improved. 6 hours later I took another 2 Tylenol because the headache came back strong. I sleep a couple of times during the day, and also slept well during the night. The next day felt a little bit better but still in bed, but was able to eat better. The next day went to the Dr. and he prescribed me Meloxicam and 6 hour later Tylenol, after that is getting better.
71 2021-02-03 fever, chills Fever 103.6F with chills; Fever 103.6F with chills; Vomiting; This is a spontaneous report from a co... Read more
Fever 103.6F with chills; Fever 103.6F with chills; Vomiting; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on 19Jan2021 at 11:15 (at the age of 71 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included hypertension, seizures, hypothyroid, and attention deficit disorder all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication names were not reported, but it was reported that she used other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination, The vaccine was given at a Nursing Home/Senior Living Facility. On 20Jan2021 at 12:00AM, the patient experienced fever 103.6F with chills, and vomiting. The patient received treatment of Tylenol 1gm once only for fever and chills. The clinical outcome of fever 103.6F with chills, and vomiting was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
71 2021-02-03 fatigue, cough, headache, respiratory tract congestion, fever Fever from 99 to 101.2 the 2nd 24 hrs. Headache neck ache severe fatigue and increased coughing and ... Read more
Fever from 99 to 101.2 the 2nd 24 hrs. Headache neck ache severe fatigue and increased coughing and congestion
71 2021-02-03 fatigue I am kind of tired; Redness and little bit of swelling, a patch that is getting bigger just below th... Read more
I am kind of tired; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: GL1283, on 15Jan2021 at 10 AM at single dose for COVID-19 immunization. The patient had some medical history, but not reported. Concomitant medications were not reported. Patient stated, she received her second dose of the COVID Pfizer vaccine (COVID 19 Vaccine) on Friday at 10 AM and usual it pained next day (16Jan2021) but they went away by the end of the day. However, she noticed that yesterday (17Jan2021) and today (18Jan2021) there was redness and little bit of swelling, a patch that was getting bigger just below the site where the injection was made. Yesterday it was smaller. Today the part was larger and little bit swollen So she thought she better see what's going on. Patient stated she was kind of tired. She was old. For treatment, the patient went to the drug store today and got some Benadryl. So, she took two Benadryl tablets at about three hours prior to the report and it hadn't effected it one way or the other. The patient didn't have any lab test. Patient's height was 5'5 and three quarters. The outcome of the events "Pain" and "Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was" was not recovered at the time of report. The outcome of tired was unknown.
71 2021-02-03 headache, chills, fever In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then... Read more
In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then noticed I had chills. Probably after 8AM I took my temp and I had a fever (102F) for about 10 hours. Started aching all over, joint and muscle aches, I also had headache (took Motrin and headache went away), no pain at the injection site. Almost like I had flu symptoms. I felt miserable all day but next day when I woke up I was fine. Went to work as normal the next day. I forgot to state I had COVID in March 2020 and the symptoms I had felt very much like it.
71 2021-02-03 fatigue, headache, chills My first dose I woke up in the morning really tired, chills, muscle aches and a headache, that laste... Read more
My first dose I woke up in the morning really tired, chills, muscle aches and a headache, that lasted all day and next day was a fine. No medication needed. I also noticed knee pain in both knees mainly when I am moving around. I was not having that problem before the vaccine.
71 2021-02-03 chills, fever Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps,... Read more
Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps, severe weakness.
71 2021-02-03 influenza like illness, chills, fever, malaise Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaki... Read more
Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner. On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.
71 2021-02-03 headache Within 15-minutes of vaccination, the patient reported a headache and feeling nauseous. EMS managed ... Read more
Within 15-minutes of vaccination, the patient reported a headache and feeling nauseous. EMS managed the patient's condition on-site.
71 2021-02-04 fatigue, chills Chills, muscle and joint pain, and fatigue from 11:00am. Till 5:00pm the day following the injectio... Read more
Chills, muscle and joint pain, and fatigue from 11:00am. Till 5:00pm the day following the injection
71 2021-02-04 fatigue Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on ... Read more
Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on right side (like a canker sore)
71 2021-02-04 headache, fever Fever 99.8-100.8, headache.
71 2021-02-04 fatigue, chills, headache Headache, tiredness, muscle pain, chills, joint pain, soreness at injection site and nausea caused ... Read more
Headache, tiredness, muscle pain, chills, joint pain, soreness at injection site and nausea caused from the really bad headache.
71 2021-02-04 chills, fever, fatigue Nausea, vomiting, fever, chills, fatigue, body ache, stomache upset
71 2021-02-04 chills, headache, fatigue about 14 hrs after receiving the second vaccine I had extreme chills, severe body aches and headach... Read more
about 14 hrs after receiving the second vaccine I had extreme chills, severe body aches and headache, pain in my eyes, moderate arm pain and fatigue. I began feeling better about 10 hrs later but continued to feel fatigued the rest of the day and had body and head ache a couple more days. I had had covid in Sept 2020 and felt worse those 10 hrs than when I had covid.
71 2021-02-04 nasopharyngitis, fever, chills, cough, headache cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea;... Read more
cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea; feeling freezing cold; chills; ache; cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration at left arm on 19Jan2021 08:15 at a single dose for COVID-19 immunization. She was sick (COVID symptoms) all Dec2020 when she was with her sister who had COVID-19. She does not know for sure that she had COVID 19 because she was never tested. She recovered from that illness about two weeks before getting the Pfizer COVID 19 vaccine first dose. The cough was all gone before she had the Pfizer COVID 19 vaccine. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient had the vaccine on 19Jan2021, two days ago and had not had a problem. She left there and went to the gym for 1 hour afterwards. Then yesterday morning she woke up and has been sick ever since with a cough and chills. She never tested positive for COVID but she was with her sister who had it during Dec2020. She had a cough similar to the one she had in Dec2020 when she was quarantined for COVID symptoms. She was not expecting anything, but it says you can have side effects if you have had COVID-19 so she was calling in about that. On 20Jan2021 she woke up at 02:00 in the morning with a cough; injection site pain which was not sore before; headache; muscle pains, chills; joint pain; fever, but not a high fever; feeling freezing cold; and nausea. She reported 'cold, chills, fever, ache'. She felt a little bit better today on 21Jan2021. She was scheduled to receive the second dose on 15Feb2021 at 08:15. The patient would like to know whether her history of COVID symptoms from Dec2020 may have aggravated her post-vaccination symptoms. The patient would like to know whether there have been other reports of similar post-vaccination as hers. The outcome of the events cough, injection site pain, headache, fever and feeling freezing cold was recovering; event muscle pain, joint pain and nausea was not recovered; event chills was recovered on 21Jan2021; and unknown for the other events.
71 2021-02-05 fatigue Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light head... Read more
Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light headed, extremely tired, sore arm, joint aches Spent the morning in bed and the afternoon on the couch. Temp 99.8 Took tylenol several times during the day and that night. By the following morning most of the symptoms had disappeared with a moderately sore left arm still present.
71 2021-02-05 malaise Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red ... Read more
Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red flushing to the skin on the face and left neck, shoulder & hip pain. BP initially was 182/98 which is elevated for me. Felt disoriented & very unwell. Over the next few days, low BP was noted @90/62, pulse 58. This occurred intermittently.
71 2021-02-07 headache APRN was notified of possible reaction to COVID-19 vaccine (lot # EN9581, exp. 5/31/21) at 2:18 pm. ... Read more
APRN was notified of possible reaction to COVID-19 vaccine (lot # EN9581, exp. 5/31/21) at 2:18 pm. Patient initially complained of tongue pain and a headache; she then began to develop throat tightness and her voice began to change and she began to clear her throat and developed a "tingling" sensation. EMS was called at 2:25pm. First dose of epinephrine 0.5mg was administered IM right anterolateral thigh at 2:25pm, the sensation of her throat closing persisted at 2:30pm and another dose was administered of epinephrine 0.5mg was administered IM left anterolateral thigh at 2:30pm. EMS arrived and patient left in ambulance at 2:35pm. Vitals: 2:20 pm BP 110/64 HR 85 O2 sat 97% 2:25 pm BP 102/64 HR 93 O2 sat 95% 2:30 pm BP 112/60 HR 87 O2 sat 95% 2:32 pm BP 120/82 HR 90 O2 sat 98%
71 2021-02-08 headache, chills She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both ar... Read more
She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both arms, the crown of her head, and on her scalp; Pfizer covid vaccine: nausea; Pfizer covid vaccine: chills; Pfizer covid vaccine: hurting at the injection site; Pfizer covid vaccine: headaches/on and off headaches; She cannot speak this morning; Pfizer covid vaccine: vomiting; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL8982, expiry date: 31May2021) intramuscular injection in right upper arm on 19Jan2021 10:00 at single dose for COVID-19 immunisation. Her second dose is scheduled on 10Feb2021. Medical history included stage 4 metastatic breast cancer. There were no concomitant medications. The patient previously took Ibrance for stage 4 metastatic breast cancer and experienced broken out in terrible rash. She is taking Ibrance for cancer, she has been taking it for a while. The past few weeks she has broken out in terrible rash. She went to a dermatologist that stated the rash was from Ibrance. She cannot speak this morning (Jan2021). Her doctors are speaking to each other and she is being told not take Ibrance by the dermatologist and to continue taking from her oncologist. Reports she had a pathology report and it showed her skin eruptions she is having is from Ibrance. She clarifies that her terrible rash is up and down both arms, the crown of her head, and on her scalp. She took the first dose of the COVID-19 vaccine a couple of weeks ago. She is having quite a bunch of side effects from the injection. The side effects she is experiencing after the COVID vaccine are nausea, vomiting, chills, hurting at the injection site which is not terrible, and on and off headaches. Events did not require a visit to emergency room or physician office. Nausea started 3 days after the receiving the vaccine on 22Jan2021. Vomiting is still ongoing on and off and started about a week and half after receiving the vaccine (Jan2021). Chills started right away and she still has the chills. It has not changed. The chills started maybe a day after receiving the vaccine (20Jan2021). Hurting at the injection site started the day after (20Jan2021) and lasted for two or three days and is still ongoing, reports it goes on and off. Reports the hurting at the injection site is not terrible. Headaches started a day or so after receiving the vaccine (20Jan2021) and is still ongoing, on and off. Reporter seriousness for events nausea, vomiting, chills, hurting at the injection site, headaches were reported as medically significant. She is currently taking Ibrance since her oncologist told her not to stop taking Ibrance. The dermatologist said her rash is related to Ibrance. When querying causality she reported that she is not sure because she has been taking Ibrance for a while. She confirms the rash started after receiving the COVID vaccine. Events outcome of nausea, vomiting, chills, hurting at the injection site, headaches was not recovered (nausea and vomiting was reported as worsened), while for others was unknown. Relatedness of drug Pfizer COVID vaccine to events for nausea, vomiting, chills, hurting at the injection site, headaches were reported as related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
71 2021-02-09 fatigue, headache I had a mild headache for 2 days; sore arm.; Had some fatigue for 2 days.; This is a spontaneous rep... Read more
I had a mild headache for 2 days; sore arm.; Had some fatigue for 2 days.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EL3248, Expiry date: unknown) via an unspecified route of administration on right arm on 23Jan2021 at 08:45 AM at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, Sjogren's syndrome, fibromyalgia and hypothyroidism. The patient has no Allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included methotrexate, atorvastatin and levothyroxine. The patient stated she had a mild headache for 2 days, sore arm and had some fatigue for 2 days on 23Jan2021 at 18:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and also since the vaccination, the patient was not been tested for COVID-19. Therapeutic measures were taken as a result of the events had a mild headache for 2 days, sore arm and had some fatigue for 2 days which was Tylenol and rest. The outcome of the events headache and fatigue was resolved on 25Jan2021 while outcome for sore arm was resolved on an unspecified date in Jan2021.
71 2021-02-09 headache following the vaccination shot on same day 2/6/21 complaints of injection site pain and headache she... Read more
following the vaccination shot on same day 2/6/21 complaints of injection site pain and headache she was found deceased in her residence 2/8/21 8:00 am
71 2021-02-09 headache, chills, fever soreness and redness where given the injection; soreness and redness where given the injection; Feve... Read more
soreness and redness where given the injection; soreness and redness where given the injection; Fever; Headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date not reported), via an unspecified route of administration at the left arm on 20Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, thyroid disorder and COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications (unspecified) in two weeks were given. On 21Jan2021 15:00, the patient experienced soreness and redness where given the injection, fever, headache, and chills. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
71 2021-02-09 headache wave of neurological effects app 5-6 inches wide in a swath starting at back of neck and proceeding ... Read more
wave of neurological effects app 5-6 inches wide in a swath starting at back of neck and proceeding up over top of head & down my face to my chin; tingling lips; minor headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiry date: unknown), via an unspecified route of administration, in the right arm, on 24Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included occipital neuralgia, migraines, and known allergies: chlorine, latex. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergy. The patient is not pregnant. The patient has not had any vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 24Jan2021 15:00, the patient experienced "a wave of neurological effects app 5-6 inches wide in a swath starting at back of neck and proceeding up over top of head and down my face to my chin. It included tingling lips and minor headache." The patient had no change in blood pressure (BP), heart rate or respirations. No flush or sensation of heat-almost a sensation of numbness. The patient did not receive any treatment for all the events. Outcome of all the events was recovering.
71 2021-02-10 headache, fatigue dental pain; fatigue; headache; loss of taste; loss of smell; body aches; This is a spontaneous repo... Read more
dental pain; fatigue; headache; loss of taste; loss of smell; body aches; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (BNT162B2), via intramuscularly on 13Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing ankylosing spondylitis and potentially being exposed to COVID. The patient's concomitant medications was not reported. Patient began to have symptoms of COVID on 16Jan2021. The symptoms include Body aches, headache, loss of taste, loss of smell, dental pain, and fatigue. Hence on 22Jan2021 the patient hospitalized and same day had discharge, the patient had, blood sampling, X-ray, oxygen, and intravenous fluid. The patient underwent lab tests and procedures which included blood test: unknown result on 22Jan2021, x-ray: unknown result on 22Jan2021. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
71 2021-02-14 headache, chills The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and bet... Read more
The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; next day she felt fine, cold but it's cold; chills; headache; First dose was on 05Jan2021/ Received the second dose on 22Jan2021; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration in left arm (by injection) on 22Jan2021 17:00 (also reported as 16:30) at a single dose for COVID-19 immunization. Medical history included allergic to yellowjacket (anaphylaxis) and bee venom. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient experienced chills and headache on 23Jan2021, next day she felt fine, cold but it's cold on 24Jan2021, itching and a rash on his right arm up to her shoulder and between her legs and small bumps on 25Jan2021, the rash now is getting little bumps on an unspecified date. Patient received Pfizer-BioNtech Covid-19 vaccine on Friday 22Jan2021 around 4:30PM (as reported). On Saturday she experienced chills and headache, next day she felt fine, cold but it's cold in the city, she didn't take anything (Tylenol). Last night she started to get itching and a rash on his right arm up to her shoulder and between her legs and small bumps. She would like to know if this side effects have been reported for the vaccine. The patient reported she is getting a little concerned. She had her 2nd dose of the Pfizer COVID vaccine on Friday, 22Jan2021. She had the side effects that Pfizer submitted in the brochure. She had them starting on Saturday. She had chills and a headache. The headache left her by Sunday morning. She now she has a rash that started last night in her thighs between her legs. Then this morning it is on her arms in the folds. She does not know if that is normal. She is wondering if this is a normal side effect and what to do about it. She has had anaphylaxis from yellow jackets before. She hopes she does not go that direction. Received the second dose on 22Jan2021 at 5 pm. The chills is hard to tell if she still has it as it is cold in the city. She took Tylenol for her headache. She used anti itch cream after she showered. The rash now is getting little bumps. First dose was on 05Jan2021 (LOT: EL0142). No expiration date or NDC for first or second dose is written on her vaccination card. She thought maybe it was her detergent, or bleach, but that is not it. Therapeutic measures were taken as a result of headache which included Tylenol and itching which included anti itch cream. The outcome of the event headache was recovered on 24Jan2021, of event itching and a rash on his right arm up to her shoulder and between her legs and small bumps was not recovered, while for the other events was unknown.
71 2021-02-17 nasal congestion, runny nose, throat pain, headache, fatigue, cough, chills, body temperature increased Extreme fatigue; Stuffy nose; Runny nose; Coughing; Sore throat at night; Slight headache; Temperatu... Read more
Extreme fatigue; Stuffy nose; Runny nose; Coughing; Sore throat at night; Slight headache; Temperature up only one degree; Chills; Unable to sleep; Body ache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9263), via an unspecified route of administration in left arm, on 22Jan2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history included slightly high blood pressure and depression. The patient was taking unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 at 12:15 PM, the patient experienced extreme fatigue, stuffy nose followed by runny nose, coughing and sore throat at night, slight headache, temperature up only one degree but chills, and unable to sleep due to body ache. These events ended quite abruptly on 29Jan2021. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 29Jan2021.
71 2021-02-17 chills, fever This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (no... Read more
This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (not pregnant) received first dose bnt162b2 (BNT162B2 also reported as product COVID 19 brand Pfizer, lot/batch number expiry date not reported), via an unspecified route of administration in left arm on 05Feb2021 00:45 at SINGLE DOSE for Covid-19 immunisation. Medical history included blood pressure abnormal and chronic kidney disease. She did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram, diltiazem, amlodipine, calcitriol and iron. The patient experienced cold sweat, slight fever and chills (all non-serious) on 06Feb2021 03:00, no treatment. The outcome of events was unknown. Information on the lot/batch number has been requested.
71 2021-02-17 chills, headache, dehydration, sweating passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chil... Read more
passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chills-shivers; Bad headache; Dizziness; Couldn't sleep; Neuropathy pain in hip/groin; This is a spontaneous report from a contactable consumer reporting for herself. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809 and expiry date unknown) on 05Feb2021 08:30 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included known allergies to statins. The patient had received first dose of BNT162B2 (lot number EL3248) on 15Jan2021 16:00 for COVID-19 immunization (vaccine location=Left arm). The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included gabapentin (GABAPENTIN), fish oil (FISH OIL), zinc (ZINC), cyanocobalamin (VITAMIN B 12), iron (IRON). No other vaccine received in four weeks. The patient experienced adverse events from 05Feb2021 at 20:30. She experienced chills-shivers, had bad head ache, dizziness, couldn't sleep, intense neuropathy pain in hip/groin when got out of bed and then passed out when went into bathroom at 5 am (06Feb2021), cut chin when fell. She felt dehydrated. Cold marble floor felt good as she had sweats, so she just layed there awhile. Her husband came to her rescue with water and cold compress for her head. She received lots of liquids and rest. She had good night's sleep on 06Feb2021. The outcome of the events was reported on 07Feb2021 as recovered.
71 2021-02-18 malaise, fatigue Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; re... Read more
Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
71 2021-02-21 chills, headache Chills, shivering, nausea, headache
71 2021-02-21 fever, chills, fatigue, headache Fever, chills, shaking,body aches, headache, dizziness, fatigue
71 2021-02-21 cough Patient began coughing immediately after sitting down for her observation. Patient had a dry cough. ... Read more
Patient began coughing immediately after sitting down for her observation. Patient had a dry cough. Vitals every 5 minutes. No acute distress, lungs were clear.
71 2021-02-21 chills, body temperature increased Temp 101, Aches, Shivering and Chills
71 2021-02-21 headache, fever severe muscle and joint pain; severe muscle and joint pain; fever 100°F; dizziness; severe headache... Read more
severe muscle and joint pain; severe muscle and joint pain; fever 100°F; dizziness; severe headache; no Appetite; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EI9262), via an unspecified route of administration on 24Jan2021 at 14:00 on the left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination and had no known allergies. The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 03Jan2021 on the left arm for COVID-19 immunization. It was reported that on 25Jan2021, the next day after the vaccination, the patient woke up with severe muscle and joint pain, fever 100°F, dizziness, severe headache and no appetite. The patient took 2 Tylenol and it got better. Six hours later she took another 2 Tylenol because the headache came back; slept a couple of times a day and had a good night's sleep. Next day, she was a little better but still in bed, she fed myself better. The next day she went to the doctor (prior appointment) and was prescribed Meloxicam and Tylenol 6 hours after and was getting better. The outcome of the events was recovered. Post vaccination, the patient has not been tested for COVID.
71 2021-02-22 fever, throat pain, headache, fatigue, chills, runny nose, sneezing, cough 4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, he... Read more
4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, headache, cold feet/hands & back, light headness -feeling might pass out, sneezing, coughing, extreme fatigue,nasal discharge, loss of taste, nausea, stomach ache, knots in throat (very painful) & swelling.
71 2021-02-22 chills Chills
71 2021-02-22 fever, chills Patient reports experiencing fever and chills that began about 7-8 hours after receiving the 2nd dos... Read more
Patient reports experiencing fever and chills that began about 7-8 hours after receiving the 2nd dose. This lasted for about 36 hours. Patient also reports having nausea and vomiting that began about 12 hours after receiving the vaccine. This also lasted for about 36 hours total after receiving the vaccine. Patient also reports increased local pain, redness, erythema 36 hours after receiving the vaccine and states that this lasted for about 96 hours. The skin redness started locally to the injection site and then spread to covering the entire upper arm.
71 2021-02-22 headache Per patient: " I received my 2nd vaccine on Friday, February 12, 2021 and started breaking out on S... Read more
Per patient: " I received my 2nd vaccine on Friday, February 12, 2021 and started breaking out on Saturday, February 13, 2021 around my forehead and into my eyebrow. I developed body aches as well as a headache and arm soreness. I went to the dermatologist on Wednesday, February 17, 2021 and they cultured the lesions and results came back positive for shingles on February 22, 2021. I called the health department to let you know. "
71 2021-02-22 fever, headache, runny nose, lethargy Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating h... Read more
Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating head ache and facial pain not relieved by #2 50mg Ultram every 4 to 5 hrs, lethargy, chapped lips and cold sore. February 23rd most symptoms gone except lethargy and cold sore.
71 2021-02-22 sneezing, runny nose This is odd and probably not vaccine related, but I thought I would report on off chance someone els... Read more
This is odd and probably not vaccine related, but I thought I would report on off chance someone else experiences this. After receiving the second vaccine, I sneezed and had a constantly runny/blocked nasal passages for almost 24 hours. It was a long night. I must have sneezed more than 100 times. Never had anything like this before in my life. about 10 AM the following day it simply stopped as fast as it started and has not reoccurred. I received the Pfizer vaccine. Had muscle/joint aches but nothing that happened was a big deal
71 2021-02-23 chills, headache, sweating Chills with violent shivering starting second night after vaccine and continued for 3 nights. Dren... Read more
Chills with violent shivering starting second night after vaccine and continued for 3 nights. Drenching night sweats overnight began the 3rd night and is continuing now but lessening slightly in degree. Headaches. Muscles ache and stiffness particularly in legs. Slight loss of balance from time to time. Loss of appetite. Rash on chest possibly caused by sweating at night. Increased severity when bruised.
71 2021-02-23 cough, fatigue, headache, influenza like illness, throat pain Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have... Read more
Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events "have been sick ever since", "flu like symptoms", headache, nausea, extreme fatigue and "hoarse" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients
71 2021-02-23 fever, cough, fatigue, chills, headache Initially on Friday onset of diarrhea, followed by fever to 101 if I remember correctly maybe slight... Read more
Initially on Friday onset of diarrhea, followed by fever to 101 if I remember correctly maybe slightly above that, cough, debilitating fatique and bone aches and chills and headaches lasting until almost 5 January. Second shot administered 01-18/2021 Pfizer Lot #EL3249 - again, significant fever, terrible chills and bone aches lasting approx 4-5 days.
71 2021-02-23 chills Very severe chills, flushing, hives, nausea
71 2021-02-24 headache - erythema diffuse body, hot flashes, headache and ecchymotic areas
71 2021-02-24 fever, lethargy 1/14/21 - Resident complained of SOB. SPO2 66% on RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% ... Read more
1/14/21 - Resident complained of SOB. SPO2 66% on RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% Binax test revealed (+) COVID results. Resident transferred to COVID wing. Family (HCP) updated and declined transfer to hospital Resident continued with fever, hypoxia and lethargy. Family elected CMO and Hospice notified. Resident died on 1/16/2021 @ 930AM.
71 2021-02-24 headache 1st dose - sore arm, foggy first couple days, moderate vertigo day 3. 2nd dose - sore arm, mild head... Read more
1st dose - sore arm, foggy first couple days, moderate vertigo day 3. 2nd dose - sore arm, mild headache first couple days, severe vertigo day 5.
71 2021-02-24 fever, chills 8:00 p.m. day of injection - Fever & Severe Chills. Chills eased about 3:00 a.m. 02/10/21 7:00 a.m.... Read more
8:00 p.m. day of injection - Fever & Severe Chills. Chills eased about 3:00 a.m. 02/10/21 7:00 a.m. 02/10/21 - abdominal muscles and unable to function extremities very weak loss of bladder control improved very, very slowly until 02/11/21 - 3:00p.m. 02/11/21 return to normal 02/11/21. No lasting consequences
71 2021-02-24 chills, runny nose Blood pressure roller coaster over 3 days: highest 148/84 down to lowest 105/85; chills, pain in upp... Read more
Blood pressure roller coaster over 3 days: highest 148/84 down to lowest 105/85; chills, pain in upper left quadrant chest on 3rd day, vision issue and pressure behind left eye after 5 minutes--pressure lasted for 3 days with different levels of pressure; chills, dripping nose on day 1, and itchiness on both arms especially around elbows--has continued
71 2021-02-24 fever, chills Chills, fever, body aches, pain at injection site
71 2021-02-24 body temperature increased Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD, hypertension and an... Read more
Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD, hypertension and anxiety and depression who presented on 2/6/2021 for evaluation of shortness of breath. Patient presented to our emergency room yesterday morning from local nursing facility rehab nursing staff reported that she had had a increased shortness of breath for the last 3 days she has been diagnosed with COVID-19 on 2-2-2021. Patient has also received both COVID-19 vaccines. Patient presented to the emergency room with labored respirations conscious awake and was on a non-rebreather at 15 L. upon arrival to our emergency room patient's temperature 101.6°, pulse 169, respirations 40 to blood pressure 142/91 and oxygen saturation 100% on 15 L non-rebreather. Patient received a chest x-ray that showed chronic emphysema and fibrotic changes in the lung no acute processes identified. Patient's white count 12.8, glucose 197, creatinine 1.2, lactic acid 4.6, cardiac enzymes negative, D-dimer 1180, patient has urine culture pending. Patient has received about 3 L normal saline boluses patient was having hypotension 86/52. Patient also received IV acetaminophen a 1000 mg IV in the emergency room along with Decadron 10 mg IV piggyback. Patient was admitted acute care for the need of IV fluids and IV antibiotics for COVID-19 and sepsis 2/12 admit Brief history and initial physical exam: Patient is a 71 year old long-term resident of Rehab and Healthcare. Unfortunately, she contracted coronavirus (COVID-19) at the nursing home. Her respiratory status started to decompensate and so she was brought into the hospital. Initial workup showed significant bilateral pleural effusions and ground-glass opacity of both lungs. She had a significant supplemental oxygen requirement. She was admitted for further evaluation and treatment. Hospital course: The patient was admitted and started on IV Remdesivir. She was given IV Decadron. She was given immune support vitamins. Despite this, her sepsis worsened. When it became apparent that the patient was not going to recover, her daughter did make her comfort care only and hospice was consulted. The patient was found to be appropriate for general inpatient hospice and was made comfort care. Her requirement for morphine and Ativan did slowly rise. Eventually, the patient did succumb to her respiratory failure. Time of death was called at 10:00 p.m. on February 15, 2021 Discharge Condition: expired. Presume cause of death with cardiopulmonary arrest secondary to acute respiratory failure secondary to coronavirus (COVID-19) pneumonia Disposition: Deceased
71 2021-02-24 headache, fatigue It is probably just a coincidence, since this would be a DELAYED reaction. On the 8th day after fir... Read more
It is probably just a coincidence, since this would be a DELAYED reaction. On the 8th day after first vaccine, I woke up with moderate muscle soreness all over, but especially in back and trunk area. Also had a moderate headache. No fever. Very uncomfortable all day, movements slow. Much fatigue. I took two naps, which is very unusual. Next day, today, still with symptoms, but improved.
71 2021-02-24 fever, headache, chills Side effects, not anaphylactic adverse reaction. Chills, fever, muscle aches, bad headache, joint pa... Read more
Side effects, not anaphylactic adverse reaction. Chills, fever, muscle aches, bad headache, joint pain, injection site pain.
71 2021-02-24 fatigue Woke up extremely hot, nauseaus. At 0410 I felt like I had to have a bowel movement, sat on toilet f... Read more
Woke up extremely hot, nauseaus. At 0410 I felt like I had to have a bowel movement, sat on toilet for awhile, projectile diarrhea began. Then vomiting. Same symptoms I had with Covid in June. extremely tired for about a week. Called my son who works for Pfizer the next day (the 4th of February). I want to reschedule my second vaccine for later in March because my Endocrinologist has put in a referral to have my antibodies tested. Unfortunately I just had a tooth extracted and am on antibiotics, not sure if that will affect the antibody test or the second vaccine.
71 2021-02-25 fatigue My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel we... Read more
My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel well; Nauseous; I got cold; Sick; was very hot and so hot; was round up/she was feeling she would faint; waves of feeling like i would pass out; it was just being very hot, then being cold; Blood drained from my head, I just knew I was going to pass out; I took 0.2 rather than the 0.3ml of the first dose; very fast heart rate intermediately for many day; squeezing of chest; muscle hurting/Pain in my body in every muscles, my fingers, my hands, my calves, my feet, my back, neck, everything; digestive disorders; feeling gassy, uneasy; stomach abdomen was just tight; abdominal issue; feeling gassy, uneasy; stomach abdomen was just tight; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: E18982), on 21Jan2021 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient reported that based on her history of reactions to medications, the nurses giving injections "decided 0.2ml instead of 0.3ml", which is what they gave, so she got 0.2 that is two-third of the shot. The 2nd shot was for 8'oclock on 11Feb2021. She is very sensitive to shots, vaccines, and to all medications and injections and things like that. She has sensitives thanks to two concussions she had in her life. She never was before that she had two concussions. Second one had a crazy man hit her after that just noticed that just have reactions not adverse or dying but definitely take rest of everything. So she take less of a shot, like a dental shot or cortisone shot, which she had taken in the past. If she has dental shot she cannot take Novocain, had to take Carbocaine or Marcaine and they give her half. Also she had been taking cortisone shot for shoulder for rotator cuff injury. They also have to give her less. Or flu shot: she takes half one week and come back for the other half the next week. Just have reactions. She told to when arrive for medication and did have one anaphylactic reaction but that was to cat skin dye, was told to this two nurses who was administering the vaccine and said to them she was really afraid to take. It is just too much for her. She knows her body. She is sure have reaction but is really afraid and don't know what is the first one will do to her. They just did two nurses and she decided that she will be taking 0.2 instead of 0.3ml which is what they gave. She got 0.2 so that two third of the shot and waited the half an hour, a nurse watched her card and 7 other cards. She did not have the anaphylactic reaction. She went home. Her arm hurt and started to get little tired. The events started the day that she got the shot. Like about 3 or 4 hours later. It is just few hours later she couldn't watch TV so went to laid down and an hour later she woke-up. She walked to her kitchen and blood drained from her head, she just knew she was going to pass out. Her stomach suddenly did not feel well. She tried to get back her bed but she was round up and as far as the bathroom. She got very nauseous, she laid down on bathroom floor. She thought she was sick but didn't round up having to use toilet of few times. Although while she was feeling she would faint. She was very hot and so hot. While lie down, she couldn't even pulling off her pajamas. So when she got cold so she was pulling a towel down and stop and she laid to for two hours, she finally got to her bed. It was a terrible experience. Next day she drank water and had potatoes prepared and went up eating back to later baked potatoes. Next day luckily she did not have repeat of the nausea. She didn't have that anymore of. She did have abdominal issue just not diarrhea or anything but just not feeling well, feeling gassy, so uneasy. This all lasted, that part lasted for 7 days. What concerned her was especially beside first day it was few days she got off again. She was just feel blood drain but not this first time she laid on floor. She couldn't sit on chair to watch TV for about 3 days. She mostly laid on bed but she would get very hot and then very cold during the day. She would get very fast heart beat not continue but really fast like heart was pounding her chest. She felt like someone has their hand inside her body squeezing her chest. She got afraid but didn't want to go hospital. She didn't think she was sick enough. She was concerned. So that was happened and this last was for about 7 days. Then the squeezing of chest part went away. She doesn't want to wind-up on the floor feeling that sick again, she felt so sick it felt like food poisoning. After that, it was just being very hot, then being cold, the fast heart rate, every muscle hurting. Those were the main things that continued for a week. And digestive disorders. It all lasted for about 13 days. She was concerned she had a very fast heart rate intermediately for many days, for about a week. And that's considered an adverse reaction and also she was getting waves of feeling like she would pass out, everything would drain from her head. She experienced stomach ache, feeling hot then cold. She wants to do precautions before taking the second dose on 11Feb2021. She did take may be 3 days later two Tylenol but didn't take anything (clarification requested). She didn't even take vitamins during that time. She was afraid to take anything so she did not. At the same time also there was pain in her body in every muscles, fingers, hands, calves, feet, back, neck, everything. Her stomach abdomen was just tight. She was concerned that last for few days. In last few days she started feel herself and now she is going again tomorrow. So that how she reacted. She doesn't know how much of this shot she told them she could tolerate because everybody is saying second shot will give you more reactions. All she can take this more than that because that was lot. She wants to be herself, don't want laying on floor, don't want to have 105 temperature or anything. The patient was asking if she should take another 0.2ml another two-third of the shot. She just asked them for half that is 0.15 would that be a big difference. She needed to know by 8 o'clock tomorrow. I might be in a queue to get it. She stated: 'So, that's my concern. I'm all alone, I'm a senior, I have no family. I lost my mother to covid. I know I need this vaccine, but I just, I cant get that sick and I'm so afraid I'll wind up with a 105 something, fainting away and no one knowing'. She was asking if reactions after the 2nd dose are worse than the 1st dose, if she didn't have anaphylaxis after 1st one, she shouldn't have it a 2nd time, right. She said, "1st half of flu shot, I get sick, then the 2nd half nothing". She also asked if she can take medications after the vaccine, like Tylenol, or irritable bowel syndrome (IBS) medication she takes as needed. The events resolved, but the patient reported it took her like 13 days before she felt better.
71 2021-02-25 fatigue, chills Severe vomiting, chills, fatigue, body aches and shakes lasting 7 days
71 2021-02-25 headache Shortly after receiving the vaccine the patient complained of a headache and nausea
71 2021-02-25 headache Within 24 hrs, experienced severe dizziness, resulting in 2 falls while attempting to stand up. Al... Read more
Within 24 hrs, experienced severe dizziness, resulting in 2 falls while attempting to stand up. Also had headache, loss of appetite, and nausea, but the alarming side effect was the dizziness. Dizziness also subsided after less than 12 hrs.
71 2021-02-26 fatigue, headache, chills I received the first Pfizer vaccine t 2:45 PM on Thursday, 2/25/21. That night when I went to bed I ... Read more
I received the first Pfizer vaccine t 2:45 PM on Thursday, 2/25/21. That night when I went to bed I felt chilled and woke up several times feeling chilled. In the morning I felt sick with similar symptoms as when I had COVID-19 in March2020. I had head pains, inner ear pains, naseau, sore muscles, and extreme fatigue. I slept the whole day, waking up and going back to sleep. I dranka little, but just didn't feel like it. I ate a piece of toast with butter that evening and then felt naseauated. I slept through the night and woke up feeling a little better the next day, but still feel tired and have some pains in my head.
71 2021-02-26 headache, malaise, fatigue Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the n... Read more
Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the next day; general malaise feeling; loss of appetite; headache; slight swelling of sinuses and rash on face. Took Benadryl the first and second nights, used hydrocortisone cream on rash, took Tylenol. End of day three feeling better, almost normal.
71 2021-02-26 sweating Systemic: Flushed / Sweating-Mild, Additional Details: pt felt flused after 10 minutes. Refused bena... Read more
Systemic: Flushed / Sweating-Mild, Additional Details: pt felt flused after 10 minutes. Refused benadryl due to previous reaction. Took asa 81 mg and zyrtec 10 mg. Symptoms resolved.
71 2021-02-27 lethargy, fever, headache, fatigue, chills 12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted... Read more
12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted 2-3 days, but the following symptoms are still present (10 Days post 2nd dose): HA, lethargy, fogginess and tiredness
71 2021-02-27 fever extreme nausea for 24 hrs., low grade fever for 48 hrs.
71 2021-02-28 chills, headache, fever, sweating Extreme Diarrhea for 5 days ( soiled pj?s, underwear, and clothes because it came on so fast and was... Read more
Extreme Diarrhea for 5 days ( soiled pj?s, underwear, and clothes because it came on so fast and was so painful that I couldn?t run to the bathroom quickly enough) Fever and chills for 5 days ( would wake up 1-2 times each night drenched in sweat) Severe headache for 4 days
71 2021-02-28 malaise I felt achy and sick as if i were getting the flu. It was difficult to walk up the stairs to go to ... Read more
I felt achy and sick as if i were getting the flu. It was difficult to walk up the stairs to go to bed, but i went to bed immediately. I was asleep by 9 pm and didn't wake up until 7 a.m. After being up for 30 minutes, i felt like myself ago and no additional effects.
71 2021-02-28 chills, headache, malaise I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in... Read more
I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in my stomach; Lot of pain in my whole body; Chills especially at night; Tinnitus; I can't hear you very well because it's so bad. I have a lot of noise in my ear and I can't listen you very well. I couldn't hear; Little side effect of the vaccine, but it continued till now and I feel so sick now; scared because she was falling; scared because she was falling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: unknown), via an unspecified route of administration on 21Jan2021 (also reported as on Wednesday) at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure high and diabetes. Concomitant medication included glimepiride (GLIMEPIRIDE) for diabetes and olmesartan (OLMESARTAN) for blood pressure high. It was reported that the patient was experiencing for over a week a lot of side effect of the vaccines. She was scared because she got dizzy which she was almost falling (also reported as scared because she was falling) in Jan2021. The patient also had headaches (a lot of headaches) and every day she had to take pills. She also felt like nauseous and pinch in her stomach. She had a lot of pain in her whole body and have chills especially at night after she had the COVID-19 Vaccine. The patient also had got a lot of tinnitus (lot of noise in her ear and can't listen very well) she can't hear very well because it's so bad. She also felt so sick now that she doesn't feel like doing nothing just to be in bed. The patient events were not recovered (continued till now). Information on the Lot/Batch number has been requested.
71 2021-02-28 fatigue Overly tired Thursday night, Friday and Saturday after injection
71 2021-02-28 malaise Severe abdominal pain. Started as diffuse cramps, surged to the most severe pain I have ever experie... Read more
Severe abdominal pain. Started as diffuse cramps, surged to the most severe pain I have ever experienced. The pain extended below my left rib through the area above my hip to my navel and then to my entire abdominal area. As noted, it ranged from severe cramps (maybe only a 4 on a NPRS) to searing pain that I would mark as a 10 on a NPRS. This subsided and then surged about 5 times in the space of 30 minutes. At one point, I got very hot, but I didn't have a fever. The pain was so bad and I felt so horribly sick that I was about to ask my husband to take me to the ER. I had a Cesarean section in 1978 followed by two natural, unmedicated VBAC births in 1981 and 1985, and, although I know we "can't remember pain," the pain I experienced last night was far, far worse than the pain of childbirth. After it went away, everything immediately went back to normal, as if it hadn't happened.
71 2021-02-28 headache, malaise, fatigue She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a ... Read more
She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: E13247) via an unspecified route of administration on 19Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included A-fib. Concomitant medication included apixaban (ELIQUIS). Had COVID-19 Vaccine on 19Jan2021 and everything was fine. Had a headache and a little bit of malaise on 20Jan2021. After two days was ok. On 21Jan2021, broke out in what she thinks was shingles. Not 100% sure if it was a major rash or shingles. Wanted to know if that was a possible side effect. Patient was taking Valaciclovir (VALTREX) for Shingles. Doctor suspected it was shingles, but it was possible she had shingles brewing before the COVID-19 Vaccine or the COVID-19 Vaccine brought the shingles out. Second COVID-19 Vaccine is scheduled for 09Feb2021, patient was scared and afraid of it. Doesn't know what to do. On 20Jan2021 she was very tired and had a headache. Next day was ok. On 21Jan2021 thought she had bug bites. Started itching. Then it began traveling and she realized it was not bug bites. She started experiencing burning. Went to two Urgent Care and her Internist. Was told it was basically shingles. Her internist was on the fence because she just had the COVID-19 Vaccine and wasn't certain. Caller stated it was ironic that she broke out after the vaccine. Caller's internist stated for any rash it would be treated the same with Valtrex. Internist stated chances were the rash was viral so if it's not shingles, would be treated with Valtrex. Rash and Itching: Wasn't very bad on Saturday, 23Jan2021, which was the first time she had someone look at it. On Sunday, 24Jan2021 it was full blown and really blossomed. Was initially treating rash as if it was bug bites. Was applying Benadryl tropical. On Sunday, 24Jan2021, started taking Valtrex. Outcome of the events headache, malaise, fatigue was recovered on n unspecified date, while unknown for the other events.
71 2021-02-28 fatigue, fever Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fev... Read more
Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fever (did not exceed 100 degrees). Underarm pain, enlarged lymph node began within 2 days post 2nd vaccine. ( Friday-Sat. Feb. 26-27) Within four days (Sunday Feb. 28) redness, swelling, pain and itching began in upper arm. ....neck pain reduced. By Monday, March 1, I contacted my family practice clinic and received a video consult with Dr.
71 2021-02-28 fatigue, headache headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a conta... Read more
headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318, expiration date was unknown), via an unspecified route of administration in the left arm on 24Jan2021 at 12:15 at a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hyperactive thyroid; known allergies to penicillin, eggs, and cashews; and severe allergy to all dairy products; all from an unknown date and unknown if ongoing. Concomitant medications included fluvastatin, ezetimibe (ZETIA), acetylsalicylic acid (BABY ASPIRIN), and unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She had not tested for COVID post vaccination. On 24Jan2021, after 2-3 hours of receiving the vaccine, the patient became very nauseous, which lasted for three days. It had eased at the time of the report. On 24Jan2021, the patient also had soreness at the site, extreme fatigue, and headache. The patient had headache for about one day; however, she managed to deal with it without pain killer. The patient drank a lot of warm water with fresh ginger and lemon (with peel) to control the nausea. The patient was very fatigued for three days following the vaccine. Therapeutic measures were taken as a result of nauseous. The patient did not receive treatment for the events "soreness at the site, extreme fatigue, and headache." The patient was recovering from the events "nauseous, soreness at the site, extreme fatigue, and headache."
71 2021-02-28 fatigue strength difficulty, tiredness, leg weakness,
71 2021-03-02 chills, headache Chills, body aches, headaches, slight nausea, sore arm
71 2021-03-02 headache Headache, upset stomach, light headed
71 2021-03-02 malaise, fatigue, headache Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a co... Read more
Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.
71 2021-03-02 headache Patient received first dose of Pfizer COVID Vaccine and reported headache and lip tingling per obser... Read more
Patient received first dose of Pfizer COVID Vaccine and reported headache and lip tingling per observation. Given benadryl 25mg x 1.
71 2021-03-03 fever, chills 2 hrs after shot Roof of mouth and tongue became rough the next morning fever up to 102 Chills down... Read more
2 hrs after shot Roof of mouth and tongue became rough the next morning fever up to 102 Chills down for the count day 3 I woke up thought I had a swollen gland on left neck and developed blisters or sensitive bumps along left side of tongue. Today 3/4 gland back to normal bumps or blisters still there moving towards tip of tongue on left side
71 2021-03-03 headache, fever Fever; nausea; headache; achy. Fever lasted several hours starting around 11:00 pm. Nausea lasted 36... Read more
Fever; nausea; headache; achy. Fever lasted several hours starting around 11:00 pm. Nausea lasted 36 hours (about), aches and pain lasted about 48 hours. Tylenol for fever.
71 2021-03-03 throat pain Left side of throat feels swollen, dry, then later notes right tonsil and right side of throat sore.... Read more
Left side of throat feels swollen, dry, then later notes right tonsil and right side of throat sore. did get oral Benedryl 50 mg. Medical Emergency called - patient transported to ED
71 2021-03-03 headache, fever, chills Received shot on 2/27 2/28 & 2/29 fever , chills, joint aches, headaches, took Tylenol for fever 2/3... Read more
Received shot on 2/27 2/28 & 2/29 fever , chills, joint aches, headaches, took Tylenol for fever 2/30 rash started at injection site. I took Benadryl but rash spread and got worse 3/4 went Emergency center for worsening rash, sever itching, and unable to sleep. I was given a Benadryl 25mg injection and a steroid shot. I was to continue taking Benadryl and set up an appointment with my PCP.
71 2021-03-03 headache, fatigue Severe Headaches Severe joint aches Severe back pain Fatigue Symptoms lasted 7 days
71 2021-03-03 headache, chills Very bad headache that started around 2 am on 3/2, lasting about 6 hours, with nausea and chills
71 2021-03-03 fatigue, malaise, chills states that she received her second Covid vaccine on Monday 03/01/21, and that yesterday she had sid... Read more
states that she received her second Covid vaccine on Monday 03/01/21, and that yesterday she had side effects of body aches, and just feeling yucky. 3/3/21, she woke up with Hives covering her body. No difficulty breathing, or swelling of Face at this time, per NP, pt to take Benadryl OTC and if Sxs worsen or do not improve she will need to come into to be seen, and if any difficulty breathing, swelling of face/tongue/throat patient is to call 911. 3/4/2021 11:52 AM 71 yo female seen today with c/o hive like rash,, first onset noted on both forearms yesterday 3/3/21 associated with severe itching, she took some benadryl last night, this may have helped for a while, however notes spreading of hive like rash to the entire body including the face starting this morning, bodyaches and chills with extreme fatigue Pt had her 2nd pfizer covid shot 48 hours ago, she denies any other new medications or products.
71 2021-03-04 headache, chills Blood pressure at 4 pm on 3 March was 150. By 8 pm that evening it was 197. Had slight head ache and... Read more
Blood pressure at 4 pm on 3 March was 150. By 8 pm that evening it was 197. Had slight head ache and face was red. Went to the ER. That night I experienced moderate chills.
71 2021-03-04 chills, headache, fever Fever, headaches, chills, sore arm. Loss of taste that started on day 3 and lasted 24 hours.
71 2021-03-04 chills, headache Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started aroun... Read more
Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started around 7am on March 3rd, when she woke up. The symptoms lasted almost all day, and he started to feel better around 6:30pm on the same day, March 3rd. He was able to eat and drink at this time without feeling nauseous. On March 4th, he experienced mild headache and was feeling a little dizzy, but much better. She is able to eat and drink, and move around the house now.
71 2021-03-04 headache, body temperature increased Temp 101.4, body aches, headache
71 2021-03-04 headache, chills, sweating had chills, sweat, body aches, joint pain, headache. by Sunday I was fine and then Tuesday I develop... Read more
had chills, sweat, body aches, joint pain, headache. by Sunday I was fine and then Tuesday I developed the worst headache of my life and my face swelled up and my eyes got puffy and I was really sick. I had joint pain and sweats and chills again.
71 2021-03-08 headache, lethargy, chills Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my ... Read more
Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my torso; feeling of muscle heaviness that I almost felt paralyzed; extreme body ache; chills; I had a bad headache; stinging on both sides of my head and on hands and feet; was very lethargic; arm became real sore and was painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiry date not reported), via an unspecified route of administration on the left arm on 27Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included mild lupus, post concussion syndrome (PPCs) and allergies: sulfur (very sensitive to large doses) from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole magnesium (NEXIUM), tramadol, alprazolam and acetylsalicylic acid (ALKA SELTZER). The patient reported that after just a few hours on 27Jan2021, their arm became real sore and was painful to use until next morning, was sore for 2 days. Hurt after much normal use. Woke up on the morning of 28Jan2021 (3 am) with chills, extreme body ache and feeling of muscle heaviness that they almost felt paralyzed. They could still move. They had a bad headache and stinging on both sides of their head and on hands and feet. They took aspirin and went back to sleep. When they got up they felt some better, but did not feel well and was very lethargic. That night they took another aspirin before bed. On the morning of 29Jan2021 (second day ) they again woke up at 3 AM to extreme body ache, the same heavy paralyzing feeling, but this time their lower back felt really heavy and there was a pounding sensation up and down their torso. They repeated the aspirin dose and went back to bed but did not sleep anymore that day. They did feel some better but still very lethargic. Next day better, but took 5 days to feel some normal w/o fatigue. The patient is very sensitive now to regular meds. Therapeutic measures were taken which included aspirin. The patient was recovering from feeling of muscle heaviness that I almost felt paralyzed, extreme body ache, chills, headache, stinging on both sides of my head and on hands and feet, lethargy recovered from arm became real sore and was painful on an unspecified date, while the outcome of the other events was unknown. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since vaccination.
71 2021-03-09 chills, headache, fatigue After COVID vaccine #2- headache started same evening around 5 pm, tiredness, painful charlie horses... Read more
After COVID vaccine #2- headache started same evening around 5 pm, tiredness, painful charlie horses. 2nd night- chills, tiredness, sore legs, difficulty walking. 3/7/21- woke up with painful legs, heaviness, unable to walk, continued mild headache. treatment include: Tylenol, Gabapentin and lidocaine cream, avoiding narcotics rehab therapies
71 2021-03-10 sleepiness, headache, fatigue beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; fa... Read more
beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; face lips; felt paralyzed/Felt like I couldn't move it like paralyzed a little bit; whole left side of body started going numb/Left side was numb around 7 or 8 that night/all left side was numb; pains in all of her face; pain and soreness in arm/arm was painful; tachycard, high heart rate; very tired, sleepy; very tired, sleepy; headache, heavy in her head; pain in both ears; This is a spontaneous report from a contactable consumer (patient). This 71-years-Old female patient received the first dose of (Pfizer Biontech Covid 19 Vaccine, Lot No. EN6198) intramuscularly at single dose on 23Feb2021 for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. Past dug included flu vaccine in Sep2020. The patient received her first dose of Covid 19 vaccine on 23Feb2021 at 3:30 in the afternoon. She came home and felt, not bad at any time but more or less towards 6:00 or 7:00 at night she started feeling bad. Her whole left side of body started going numb around 7 or 8 that night. Her arm was painful, face lips and all left side was numb. Felt like she couldn't move it like paralyzed a little bit. Clarified as whole left side, even her leg, her feet everything on that left side. She started feeling pains in bones of head, especially her face, clarified all of her face and her left side was numb even her lips on the left side were numb. Her tongue was a little numb. She had muscle and joint pain. The pain, of course, in the arm, but that was normal. Clarified pain in the arm as the injection site. She didn't feel any swell there. She did not take medication for anything. She used a lotion. The lotion was trividol aloe vera arnica caleudula and helped to relive the pain. The arm was still a little painful but it's not bad but that feeling made her tachycard, clarified as high heart rate, feeling like boom boom boom, but she did not have any shortness of breath. The high heart rate was gone the same day. She had no fever or chills. She felt very tired and slept for about 10 hours but during the sleepy she started feeling a headache she couldn't get up because she was so tired and she felt pain in both ears. She had not been to the doctor in a while. She was still old fashioned so she carries everything in a little telephone book. While trying to read information caller states she had to change her eyes. She still felt numbness in left side of left leg but she thought it might be because she had not been exercising. When she was waking up around 9am in the morning, it was yesterday that she felt better in regards to the paralyzed feeling. When pains in her face came she felt and she thought what is this? It only lasted for a little while. It was during the night. The pain and soreness in arm at injection site is still there, she did not feel any swelling, or hot at that site. She confirmed she still felt a little tired, sleepy. It's getting better. She may feel a little heavy in her head and would like to go to sleep, but she was not sleeping. She had many things to do and knew she had to be up. The headache went away and was gone on 24Feb2021. It was persisting for a while, not too hard or heavy, but it resolved by 2 or 3 in the afternoon on the 24th. In regarding to pain in ears she mentioned she no longer had. She had beeps, noise in her ears even at the time she went to bed it was better. The outcome of events paralyzed, pain in arm, tired, sleepy, was recovering, the outcome of events tachycard, pains in all of her face, pain in both ears was resovled, the outcome of other events was unknown.
71 2021-03-11 headache Afib episode; rapid heart beat; pain in jaw; diarrhea; headache; nausea; dizziness; This is a sponta... Read more
Afib episode; rapid heart beat; pain in jaw; diarrhea; headache; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number El266) via an unspecified route of administration in the left arm on 05Mar2021 at 09:00 (at the age of 71-year-old) at single dose for COVID-19 immunisation. Relevant medical history included atrial fibrillation, asthma, chronic obstructive pulmonary disease, high cholesterol, acid reflux disease, depression and anxiety. Concomitant medications included clonazepam, apixaban (ELIQUIS), fluoxetine, metoprolol and simvastatin. On 07Mar2021 at 14:00, the patient experienced Afib episode, rapid heart beat, pain in jaw, diarrhea, headache, nausea and dizziness; the events Afib episode and rapid heart beat were considered serious as life-threatening. The patient received corrective treatment for the reported events, which included 2 tablets of metoprolol. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. The patient recovered from the events on an unspecified date. No follow-up attempts are possible. No further information is expected.
71 2021-03-11 fever, chills, dehydration led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (... Read more
led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); Nausea; shivers; fever; dehydration; This is a spontaneous report from a non-contactable consumer (patient) 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry date not reported) via an unspecified route of administration, on 22Feb2021 (in the age of 71-years-old) at single dose for covid-19 immunization. Medical history included chronic headaches, high cholesterol, high blood pressure and minor heart condition. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included candesartan, rosuvastatin, gabapentin, topiramate, amitriptyline and erenumab aooe (AIMOVIG), all from an unspecified date for an unspecified indication. It was reported that 2 days after second dose (reported as 24Feb2021), the patient experienced nausea, shivers, fever and dehydration which led to a fall (possible faint) that caused a head injury (bone chip above her eye). As a result, the patient had an ER visit and they provided her with fluids and stitches. The outcome of events was reported as 'recovering'. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
71 2021-03-15 headache, fatigue, cough Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to conce... Read more
Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to concentrate , extreme weakness & fatigue, extreme focused joint pain, headache, coughing and difficulty breathing requiring multiple nebulizer uses every 2 hours over 2 weeks, headache. Face & body rash, . Persistent exhaustion continues requiring 2-3 hour daily naps & non Fibro brain fog continues at 3 weeks.
71 2021-03-21 headache Patient presented with frequent falls and left sided weakness with severe headaches for greater then... Read more
Patient presented with frequent falls and left sided weakness with severe headaches for greater then 24 hours.
71 2021-03-21 fever, headache, fatigue extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid ... Read more
extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid heart beat; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6205, via an unspecified route of administration, administered in left arm on 04Mar2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure, pre-diabetic, penicillin allergies, allergies to sulfa drugs and bee stings. Concomitant medication included calcium. Historical vaccine included BNT162B2 on 11Feb2021 (lot number: EM9810) for COVID-19 immunization. On 04Mar2021, after 1 hour, the patient experienced shortness of breath and rapid heartbeat. At 12 hours, severe headache, fever (100 degrees) nausea, faintness, extreme fatigue 24 hours later, started to feel normal again 6 hours later. No treatment information was reported. The outcome of the events shortness of breath and rapid heartbeat was recovered on 04Mar2021, For events faintness, severe headache, fever (100 degrees), nausea and extreme fatigue was recovered on 05Mar2021. No follow-up attempts are possible. No further information is expected.
71 2021-03-23 fatigue, throat irritation, headache, malaise, sleepiness 15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat ... Read more
15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat tightness, sensation of difficulty swallowing. Then abdominal pain, nausea, then feeling of something really wrong, I didn?t feel well, then got weaker and weaker, couldn?t lift arms, and felt extremely fatigued, trouble staying awake. Taken by ambulance to medical center. On route, ambulance stopped and another team came in. I was given epinephrine, zofran, Benadryl, and maybe a steroid? Not sure. When I arrived at hospital, t think I was given dexamethasone and famotidine. I was barely awake but could speak. Could not hold anything. After several hours, they woke me up, I felt myself again, and I was discharged. Following days I felt exhausted and dizzy, and had a headache. Took prednisone for five days.
71 2021-03-23 headache, fever, malaise, dehydration The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias... Read more
The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias, malaise. Patient related she was in her normal state of health and only started to feel poorly after she received her second COVID-19 vaccination three days earlier. She interestingly related that after her first Pfizer COVID-19 vaccination she had significant burning in her stomach that she noted but no other major symptoms and notably did not experience this severe burning in her stomach after the second dose. She denied any chest pain, current dyspnea, productive cough, sore throat, urinary symptoms, sick contacts. She has no history of C. difficile, no recent antibiotics, no recent spoiled foods, no recent travel, no history of radiation. She does have a history of GERD and has had gastritis with mild gastrointestinal bleeding in the past and undergone EGD negative for H. pylori infection. She also has undergone colonoscopies with polyps that have been removed and reported as tubular adenomas. As her hospitalization progressed, she was diagnosed with Severe Sepsis due to E. Coli bacteremia in setting of liver abscess, Cholelithiasis without acute cholecystitis, Atrial Fibrillation with rapid ventricular response, Transaminitis (which resolved). Patient was appropriately treated for these conditions. Also, her known uncontrolled diabetes was treated. Per an Infection Disease note on 3/9/21: The patient has had hx of biliary colic (self diagnosis) now with discovery of non-obstructive cholelithiasis on RUQ US it is plausible that the abscess originated from self limiting cholecystitis/cholangitis which would be consistent with recent abdominal pain exacerbated with oral intake. Difficult to state definitively any relation to COVID-19 vaccination, though may have resulted from associated dehydration. Additional COVID vaccine info (both Pfizer): first dose: 2/7/21 lot# EN 5318 second dose: 2/28/21 lot# EN6202
71 2021-03-24 headache Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk o... Read more
Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk or get out of a chair); Severe weakness (could not walk or get out of a chair); Nausea; Diarrhea; Mild headache; Blurred vision; Significant swelling at injection site which spread to full upper arm; Significant swelling at injection site which spread to full upper arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 08:00 (lot number: EN6199) as single dose for COVID-19 immunisation. Medical history included osteoporosis (not bothersome), known allergies to some antibiotics, and felt dehydrated. The patient was not pregnant at the time of vaccination. The patient was taking other medications like grapefruit juice. The patient previously received first dose of bnt162b2 on 12Feb2021 (dose number 1, lot number: EL9267, administration time: 08:00 AM, vaccine location: left arm). No other vaccines received four weeks prior to COVID vaccination. On 05Mar2021 12:30, the patient experienced severe weakness (could not walk or get out of a chair), delirium (was convinced that (name) had taken over her body and was the cause of her illness), nausea, diarrhea, mild headache, blurred vision, significant swelling at injection site which spread to full upper arm over next three days and remains troublesome. Other symptoms (unspecified) lessened within two to three days and are no longer of concern. The AEs resulted in doctor or other healthcare professional office/clinic visit. Event 'significant swelling at injection site which spread to full upper arm' were treated with application of steroid cream (for arm only). Outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination.
71 2021-03-24 chills, headache, sleepiness, fatigue chills; hives; headache; extreme fatigue/became very tired/exhausted; Couldn't stay awake; cannot fu... Read more
chills; hives; headache; extreme fatigue/became very tired/exhausted; Couldn't stay awake; cannot function; This is a spontaneous report from contactable nurse (patient) via medical information team. A 71-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unknown route of administration on 12Mar2021 at 11:30 at single dose for COVID-19 immunization in airfield where they build airplanes. Medical history included spleen removed many years ago due to enlargement from the blood disorder. Also had ongoing spherocytosis (States takes B12 and Folic Acid for this condition), ongoing sleep disorder, ongoing narcolepsy, chronic fatigue syndrome. She got pneumonia and respiratory failure after pneumonia vaccine and was hospitalized for 6 weeks. This happened years ago. She was almost died. So she avoids vaccines. Concomitant medications included ongoing methylphenidate hydrochloride (RITALIN) for sleep disorder and narcolepsy (20 years), folic acid for spherocytosis, cyanocobalamin (B12-VITAMIIN) for spherocytosis. No prior vaccinations (within 4 weeks). Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 12Mar2021 at 11:30 (Friday as reported). In the evening she started experiencing some reactions (caller states she got the paper with the side effects and it mentions that they are usually worse after the second dose of the vaccine); chills, hives, headache and extreme fatigue on 12Mar2021. She is still very tired (crippling fatigue) and her headache is not so bad. She felt fine until around 1700 of the same day, when she experienced chills, hives, headache, became very tired, couldn't stay awake and went to bed. The next day she still had a headache, was still tired, hives were gone. At this time, just the extreme fatigue is continuing. States that today she is so tired she cannot function. Also mentions that she did not get a vaccine card from the facility that administered the vaccination. States that she is sorry that she got the product because she has a history of chronic fatigue syndrome and wondered if this would trigger it; but that her doctor said it would not. Caller feels that it has, because she can't function and this is terrible. She was afraid to get the second dose if she felt this crappy after the first one. She had no soreness or anything from the injection. With this amount of fatigue, she is just exhausted. States she has not been seen by her doctor, did not expect her doctor to do anything. A visit to emergency room or physician office was not required for events. Events were reported as medically significant. Specific causality was not provided for each event by the reporter. The outcome of event hives recovered on 13Mar2021; for events headache and fatigue was not recovered; for other events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the events,chills, hives, headache, extreme fatigue ,somnolence and cannot function cannot be completely ruled out.
71 2021-03-25 lethargy The first injection was uneventful. 30 hours after the second injection, respectively, patient sudde... Read more
The first injection was uneventful. 30 hours after the second injection, respectively, patient suddenly became dizzy. VS assessed. BP 90s/40s, which is abnormal for her, HR 30's which is abnormal, and temperature 95.1 orally. She became lethargic. EMS called and confirmed the same VS. Atropine give three times according to protocol without change in HR. Epinephrine dose given with some improvement in HR, but unable to sustain. Pt transported via EMS to Hospital where she was warmed mechanically, started on an IV epinephrine drip and transported to the cardiac ICU where she was monitored for 2 days. Clinically the patient improved after her body temperature normalized.
71 2021-03-25 fatigue heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day... Read more
heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day after the vaccination; 6th day after the shot she had hot flashes and swelling; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Feb2021 as SINGLE DOSE for COVID-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. Medical history included allergies to penicillin and some other things. There were no concomitant medications. The patient experienced heart fluttering and dizziness 2nd day after the vaccination; repeated 3rd day after the shot; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness. All events started in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was given for the events. The outcome of all events was unknown. Information on the lot/ batch number has been requested.
71 2021-03-27 malaise On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eat... Read more
On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eaten that morning: mashed potatoes, milk, cream of wheat - Throughout the day, patient notes she was not feeling well. At 6 PM, she developed rashes on her hip, groin, and abdomen. At 7 PM, she took diphenhydramine 25 mg. By then, her mouth was swollen. Her tongue also started to swell. At 9:30 PM, she had increase itching, burning sensation, and hives worsened. Developed a large rash on her butt. At 10 pm, took a second diphenhydramine; notes she had tongue swelling voice changes (gravel-like quality), and bilateral facial swelling. She was also breathing rapidly. Went into the ER, was checked in after ~3 minutes. She was administered epinephrine IM, IV diphenhydramine, solumedrol 125 mg, and IV famotidine. Patient was also intubated for respiratory distress and airway swelling, and admitted to the ICU. Was intubated until the afternoon of the following day.
71 2021-03-28 sweating, malaise Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swel... Read more
Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
71 2021-03-30 fatigue Right lower extremity DVT; Bilateral PE; Severe fatigue; This is a spontaneous report from a contact... Read more
Right lower extremity DVT; Bilateral PE; Severe fatigue; This is a spontaneous report from a contactable physician. A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9269) via an unspecified route of administration on 25Feb2021 at a single dose for COVID-19 immunization. Medical history included Allergies: adhesive, CT scan dye & flu shot. Concomitant medication included rosuvastatin. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient also previously took Demerol, guaifenesin;phenylephrine hydrochloride (ENTEX), epinephrine, amoxicillin;clavulanic acid (AUGMENTIN) and experienced allergies. On 03Mar2021 17:15 the patient experienced severe fatigue, right lower extremity DVT, Bilateral PE. Events were considered serious, due to hospitalization for 1 day and life threatening. Treatment was received for the adverse event which included apixaban (ELIQUIS). The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 with unknown result on an unknown date. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. Outcome of the events was recovering. Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
71 2021-03-30 pneumonia, sweating, headache, fatigue, cough, chills, nasal congestion lung infection; horrible cough; headache; chills; nasal congestion; Exhaustion; sweats; This is a sp... Read more
lung infection; horrible cough; headache; chills; nasal congestion; Exhaustion; sweats; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on Feb2021 (reported as 27Jan2021; pending clarification) (lot number: EN62co) as single dose at the age of 71 years old for COVID-19 immunisation. Medical history included known allergies (unspecified). The patient was not pregnant at the time of vaccination. Concomitant medication included omeprazole (OMEPRAZEN), taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 27Jan2021 05:30 PM (lot number: ELX47) for COVID-19 immunization. The patient developed a severe lung infection two weeks and two days after her second vaccine (06Mar2021 05:00). She had a horrible cough, headache, chills, sweats, nasal congestion and exhaustion. She has been in bed for 13 days. The AEs resulted in doctor or other healthcare professional office/clinic visit. The patient was given steroid shot and brea (unspecified) as treatment for the adverse events. The patient was not diagnosed with COVID prior to vaccination. The patient underwent lab tests and procedures which included two chest x-rays with unknown results, both on unspecified dates; and COVID-19 nasal swab: negative on 06Mar2021 and also negative on 08Mar2021. The patient has not recovered from all the events at the time of this report.
71 2021-04-01 fever, headache Fever; Headache; Redness; Stiffness; Bruising; Neck pain; pain Swelling/Throbbing; pain Swelling; Th... Read more
Fever; Headache; Redness; Stiffness; Bruising; Neck pain; pain Swelling/Throbbing; pain Swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL3302, COVID 19) administered in left arm via an unspecified route of administration on 25Feb2021 at 11:30 AM at single dose for COVID-19 immunization. Medical history included Sarcoma cancer (amputated hand), heart failure, patient was allergic to Morphine, nitroglycerin, pertussis, walnuts, corn and bees. Concomitant medications were not reported. On 04Feb2021 at 12:30 PM, patient received first dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL0142) administered in left arm for covid-19 immunization. No other vaccine was given in four weeks. It was reported that patient was given other medications in two weeks: 15 meds too many to list. On 25Feb2021 at 22:00, patient experienced fever, headache, redness, stiffness, bruising, neck pain, pain swelling and throbbing which resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient received treatment with Meloxicam for 10 days for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.
71 2021-04-02 fatigue, respiratory tract congestion, cough Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and tur... Read more
Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
71 2021-04-03 fatigue Six days after receiving the vaccine I woke up on Friday, March 12, with a complete feeling of exhau... Read more
Six days after receiving the vaccine I woke up on Friday, March 12, with a complete feeling of exhaustion. Weakness was extreme in my whole left side and could barely put weight on the left side. I thought this would pass so tried to get along. The next day, Saturday, March 13, the complete exhaustion was even worse. Trying to get out of bed was very hard. I called a friend and went to hospital here . I was admitted, tested, and kept for several days. The report came back that I had a series of "mini" strokes on the right side of my brain, affecting the left side of my body. I could no longer walk at all without aide of person or a walker, After that I was taken to rebab, . I was given pt, OT, etc, and discharged several days later. No doctor or staff could tell me whether this was caused by the vaccine but the close days of administering the vaccine and the sudden onset of symptoms make me very concerned. How can I take a 2nd vaccine without knowing if that will have a worse effect or kill me? Can I take a different vaccine for the 2nd round, without a risk of something worse happening? Can you report to me if there is any correlation at all between this vaccine and my mini strokes?
71 2021-04-09 fever, influenza like illness, headache Headache; Low grade temperature; Flu like symptoms achy; Flu like symptoms achy; This is a spontaneo... Read more
Headache; Low grade temperature; Flu like symptoms achy; Flu like symptoms achy; This is a spontaneous report from a contactable Nurse (Patient herself). A 71-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6207, Expiration Date: Unknown) via intramuscular route of administration in the left arm (Left deltoid) on 18Mar2021 at 15:00 as SINGLE DOSE for COVID-19 Immunization. The patients medical history included ongoing Psoriasis and Psoriatic arthritis from 2008. She had an MI and told her she needed to be on it for a year because of the stent. She has environmental allergies diagnosed 1998. Concomitant medication included Brilinta from 19Oct2021 at 90 mg twice daily as blood thinner. The patient had no family history. The patient had not tested for COVID-19 prior to vaccination and not tested after receiving vaccination. The patient experienced Low grade temperature, Flu like symptoms achy on 24Mar2021 01:00 and Headache on 25Mar2021:07:00 week after receiving the injection. The patient was on a blood thinner because she had a heart attack in Oct 2020. She had first dose a week ago today. She felt fine and had no flu like symptoms. She just had a little soreness. Last night, she had a low grade temperature and feels flu like today and is achy. She checked her temperature this morning. She is normally 97.8 degrees and it was 98.9 degrees. She has psoriatic arthritis and is achy anyway because of that. She has a slight headache when she woke up this morning. She did fine for a week, and through the night, developed these symptoms. No ER or physician's office required. The reporter assessed the events as serious. The outcome of the event headache was not recovered and outcome of all other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
71 2021-04-09 fatigue Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan... Read more
Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan. All came back normal. March 26, MRI done. That showed a stroke. Then on March 31st, saw Drs. (neurologist). Confirmed the stroke and suggested Speech Therapy. Starting on April 19, Sppech Therapy begins. Since Stroke, I have to sleep 12-15 hours a day.
71 2021-04-11 headache About 30 minutes after 2nd vaccine, I felt abrupt pain, shocks and tightening in 3 fingers on my rig... Read more
About 30 minutes after 2nd vaccine, I felt abrupt pain, shocks and tightening in 3 fingers on my right hand, starting at the knuckles down to finger tips. Pain occurred with or without movement. Knuckles are swollen on that On day 4, pain moved from knuckle to the joint between knuckle and finger tip. Pain occurs mostly with movement but not always, and is from mild to moderate pain. It is day 16 post vaccine, and I still have intermittent pain in the 3 fingers where I hadn?t previously had any prior to vaccine. 30 hrs after 2nd vaccine, I also had a severe headache lasting about 1 1/2 hrs.
71 2021-04-14 cough Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 -... Read more
Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 - Hypotension M25.551 - Right hip pain Z79.01 - On apixaban therapy
71 2021-04-20 malaise, headache, fatigue 4/14-Resident c/o not feeling well and declined scheduled dialysis. c/o bilateral shoulder pain and... Read more
4/14-Resident c/o not feeling well and declined scheduled dialysis. c/o bilateral shoulder pain and fatigue. AP- 44, BP- 80/45, c/o headache, no chest pain and no SOB. Sent to CMC ER- patient deceased on 4/14/2021.
71 2021-04-22 headache Humira sent her into AFIB; Headache/She had headaches for 2 weeks after receiving her Covid-19 vacci... Read more
Humira sent her into AFIB; Headache/She had headaches for 2 weeks after receiving her Covid-19 vaccine; Pain in eyes; She awoke and realized her tongue was swelling; throat felt like it was closing; This is a spontaneous report from a contactable consumer based on information received by Pfizer (manufacturer control number:-BMS-2021-036694) license party for apixaban (ELIQUIS). This case was received via Pfizer (Reference number: 2021402995) on 09-Apr-2021 and was forwarded to a company on 13-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Humira sent her into AFIB) in 71-year-old female patient who received apixaban (Eliquis) for an unknown indication. The occurrence of additional non-serious events is detailed below CO-SUSPECT PRODUCTS included Covid-19 Vaccine for an unknown indication and adalimumab (Humira) for an unknown indication. Concurrent medical conditions included Pityriasis rubra pilaris (Pityriasis rubra pilaris.) in October 2012. On an unknown date, the patient started Eliquis (unknown route). On 08-Mar-2021, the patient started Covid-19 Vaccine (unknown route) Arm, Left - Administered at 3:00PM on 08-Mar-2021. In January 2014, the patient started Humira (unknown route). On the same day, the patient experienced HEADACHE (Headache/She had headaches for 2 weeks after receiving her Covid-19 vaccine), EYE PAIN (Pain in eyes) and SWOLLEN TONGUE (She awoke and realized her tongue was swelling). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seriousness criterion medically significant). The action taken with Eliquis (Unknown) was unknown. In March 2021, HEADACHE and EYE PAIN resolved. On 08-Apr-2021, SWOLLEN TONGUE resolved. At the time of the report, ATRIAL FIBRILLATION outcome was unknown. She had an immediate reaction to the COVID-19 Vaccine. She said she had pain go through to the top of her head, and she thought her head was going to explode. She said the pain in her head hurt so bad: from 8-Mar-2021 to Mar-2021). She had an immediate reaction to the COVID-19 Vaccine. She said she had pain go through to the top of her head, and she thought her head was going to explode. She said the pain in her head hurt so bad: In an unspecified Dates for she closed her eyes because the light was giving her severe pain in her eyes: (From:08-Mar 2021 to Mar-2021). She closed her eyes because the light was giving her severe pain in her eyes in an unspecified Dates for She awoke and realized her tongue was swelling: (From: 8-Mar-2021 to: 8-Mar-2021). She awoke and realized her tongue was swelling. She awoke and realized her throat felt like it was closing: (From: 08-Mar-2021 to 8-Mar-2021). She awoke and realized her throat felt like it was closing: unspecified Dates for She had headaches for 2 weeks after receiving her COVID-19 Vaccine. She said the headache happened between every afternoon at the top of her head: (From: Mar-2021 To: Mar-2021). She had headaches for 2 weeks after receiving her COVID-19 vaccine. She said the headache happened between every afternoon at the top of her head: (From: Mar-2021 to Mar-2021). She had headaches for 2 weeks after receiving her COVID-19 Vaccine. She said the headache happened between every afternoon at the top of her head. Humira sent her into AFIB. Unspecified Dates for COVID-19 Vaccine: (From 8-Mar-2021 Stop: Unspecified) Humira (From: Jan-2014 to Sep-2015). she no longer had the product information because it had taken the Humira so long ago. Patient Medical History: Pityriasis rubra pilaris (From: Oct-2012 To: Ongoing). She stated Pityriasis Rubra Pilaris (PRP) was a rare dermatological autoimmune disease and she was in remission since Sep-2015 & it would not ever go away fully. She took Methotrexate, steroids and Humira. She said it took 3 doctors before she found a dermatologist who saved her life. She said the "PRP" covered 99% of her body at the time she was diagnosed. She said she was on Humira from Jan-2014 until she went into remission in Sep-2015. She got the first COVID-19 vaccine, and they will not let her have the second COVID-19 Vaccine because she had such an adverse reaction to the first COVID-19 Vaccine. She said no one would giver her any information about the COVID-19 Vaccine or answer any of her questions. She said her problem with the COVID-19 Vaccine was she had an underlying condition. She said she was 71 years old, and had been through it all. She would be transferred to have her COVID-19 Vaccine questions addressed. Patient Height: probably 55"-56". Patient Weight: probably 210 lbs., as provided by caller, who said she never weighed this much before Reported she was in remission for her autoimmune disease. She said she was put on Humira for her autoimmune disease, and the Humira sent her into AFIB. She said she had to have an ablation of all 4 heart chambers, and then was put on apixaban. She said she then had back surgery, and now had no feeling in her right leg from the right knee down. She said her heart had stopped 3 times in the past, and she was brought back each time. She said she was lucky to be alive, and didn't want to complain because she knows there are other that have it worse than her. She tried to get her second COVID-19 Vaccine on Monday, 29-Mar-2021. She said after she told the COVID-19 Vaccination staff what happened after her first COVID-19 Vaccine, the vaccination staff all freaked out. She said the COVID-19 Vaccination staff told her she could not get the second COVID-19 Vaccine dose. Reported she and her husband went through a drive-thru COVID-19 Vaccination facility, and she was on the passenger side of the car. She said she got her COVID-19 Vaccine in her left arm. She said because of her issue with her right leg, she had physical therapy for 3 years, and now had to use a 4-prong cane for the rest of her life. She said a male nurse at the COVID-19 Vaccination facility helped her out of the car, and administered the COVID-1 9 Vaccine in her left arm. She said she had an immediate reaction to the COVID-19 Vaccine. She said she had pain go through to the top of her head, and she thought her head was going to explode. She said the pain in her head hurt so bad. She said she closed her eyes because the light was giving her severe pain in her eyes. She said the male nurse made her husband move their car into another lane, and she had to wait for 30-45 minutes in the car. She said her headache got worse, and the male nurse made her lay down in the car while she waited. She said she did not have any further adverse reaction while she was at the vaccination facility. She said when she got home, 2 hours later, her husband made her lay down because he did not want her to go into AFIB. She clarified she had PVCs, and knew when her heart was OK, and when it was not. She said she did not want to go into AFIB. She said she took her heart medication (Atenolol 50mg). She clarified she took Atenolol 50mg 3 times a day. She clarified she arrived home at 4:00PM, when she would normally. take her second daily dose of Atenolol 50mg. She clarified after she got home she laid in bed in the dark, and put a cold wash rag over her eyes. She said she must have dozed off, and when she awoke realized her tongue was swelling and her throat felt like it was closing. She said it was about an hour later, at 5:00PM. She said her husband wanted to take her to the emergency room of a hospital that was about 40 minutes away, but she felt the emergency room was too far away. She said her husband gave her 2 doses of Benadryl (25m tablets). She clarified she took 1 Benadryl 25mg tablet, and waited about a half an hour before she took the second Benadryl 25mg tablet. She said she took another dose of Atenolol 50mg because the Atenolol brings her blood pressure right down. She said she was fine after 2 hours. She clarified her tongue swelling and throat closing resolved. She said her husband gave her that length of time to recover before deciding whether he had to take her to the hospital. Treatment: Benadryl 25mg pink tablet (Stated she took 1 Benadryl 25mg tablet twice, about a half hour between doses). She cannot take generic medication because it does not do anything. Reported because her eyes are so bad, so cannot rive anymore, and needed a magnifying glass to read the Benadryl, Atenolol 50mg tablet (State she takes 1 Atenolol 50mg tablet, three times a day, daily). Reported the Atenolol 50mg tablet was dispensed in a pharmacy bottle and had. She said the Atenolol 50mg tablet. Reported that she had headaches for 2 weeks after receiving her COVID-1 9 Vaccine. She said the headache happened between 3:00PM- 4:00PM every afternoon at the top of her head. She said the headaches would last until 11:00PM when she went to bed. She said the headaches were not bad, but a dull ache. She said she had sinus problems, and knew the difference between a sinus headache, and a headache at the top of her head. She declined any headache treatment, saying she didn't take over-the-counter medications, like Advil, because over-the- outer medications were bad for her heart. she knew she was going to be the exception with her Pityriasis Rubra Pilaris. PLM9TDQX VACCINE. Vaccination was given of Administration of Pfizer vaccine considered as suspect: Arm, Left. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None Additional Vaccines Administered on Same Date of the Pfizer Suspect. Reported She had her first COVID-19 Vaccine administered to her at a drive thru vaccine clinic on 08-Mar-2021. She said she had an immediate reaction to the COVID-19 Vaccine. She said she had pain go through to the top of her head, and she thought her head was going to explode. She said the pain in her head hurt so bad. She said she closed her eyes because the light was giving her severe pain in her eyes. She said she had to wait for 30-45 minutes in the car. She said her headache got worse while she was waiting, and the nurse made her lay down in the car. She said she did not have any further adverse reaction until she got home, 2 hours later. She said after she got home, she laid in bed in the dark, and put a cold wash rag over her eyes. She said she must have dozed off, and when she awoke, she realized her tongue was swelling and her throat felt like it was closing. She said it was about an hour later, at 5:00PM. She said her husband wanted to take her to the emergency room of a hospital that was about 40 minutes away, but she felt the emergency room was too far away. She said her husband gave her a Benadryl 25mg tablet twice, about a half an hour apart. She said she took a dose of Atenolol 50mg because the Atenolol brings her blood pressure right down. She said she was fine after 2 hours. She said her tongue swelling and throat closing resolved by 10:00PM on 08-Mar-2021. She said she had headaches for 2 weeks after receiving her COVID-19 Vaccine. She said the headache happened between every afternoon at the top of her head. She said the headaches would last until when she went to bed. She said the headaches were not bad, but a dull ache. Pityriasis Rubra Pilaris and required constant redirection. For Eliquis (Unknown), the reporter did not provide any causality assessments. Sender's Comments: BMS Medical Evaluation Comment: This 71-year-old patient had atrial fibrillation after therapy with apixaban. Elderly age can be associated with increased risk of arrhythmias and based on the absence of etiological plausibility; the reported event is considered not related to apixaban.
71 2021-04-23 fatigue, sleepiness, chills, fever, headache chills; slight temperature; body aches; headache; dizziness; extreme fatigue; no appetite; very slee... Read more
chills; slight temperature; body aches; headache; dizziness; extreme fatigue; no appetite; very sleepy; This is a spontaneous report from a contactable consumer. This consumer reported for herself that a 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 08Feb2021 13:30 (at the age of 71-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. No chronic health conditions were reported for patient. Concomitant medications included daily calcium and vitamin pill. The patient previously took ciprofloxacin and experienced drug hypersensitivity, historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on on 18Jan2021 at 02:00 pm (at the age of 71-year-old) as single dose for COVID-19 immunization. On 08Feb2021 at 11:45Pm, the patient reported that he had these symptoms for the 2 days following vaccine included chills, slight temperature, body aches, headache, dizziness, extreme fatigue, no appetite and was very sleepy. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior or post to the vaccination. Patient did not receive any treatment for the events. Events were considered non-serious as reported. Patient was recovered with sequelae form all the events. Information regarding Batch/ Lot number have been requested
71 2021-04-24 fatigue She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said th... Read more
She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said this what she has, almost like a fibromyalgia; Shingles became aggravated; she had had broken toe on the other foot that was killing her; total fatigue, no energy at all; total fatigue, no energy at all; abscess on tooth that will be pulled tomorrow; She doesn't have the strength that she had before; This is a spontaneous report received from a contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiration date: UNKNOWN), dose 2 via an unspecified route of administration on 11Mar2021 12:00 as SINGLE DOSE, dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EN620) as SINGLE DOSE for covid-19 immunisation. The patients medical history included ongoing asthma since she was 4 years old, ongoing herpes zoster (Shingles) since Nov2019, Raynaud's phenomenon for 20 years, High anxiety, gastroesophageal reflux disease from 4 years. Concomitant medications included amoxicillin at an unspecified dose taken for an unspecified indication for 7.5 days from 29Mar2021 to 05Apr2021; Advair Disc at an unspecified dose taken for an unspecified indication for maybe 30 years she is prescribed twice a day but takes it only once day, fluticasone propionate, salmeterol xinafoate (PROAIR BRONQUIAL) taken for an unspecified indication from an unspecified start date and ongoing; she had been on this for maybe 30 years, as needed, montelukast sodium (SINGULAIR) taken for asthma from an unspecified start date and ongoing for 30 years, multivitamin, sambucus nigra, sodium, zinc (MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC) taken for an unspecified indication from an unspecified start date and ongoing, she says she has been taking this forever because she never ate vegetables, magnesium sulfate (MAGNESIUM SULFATE) taken for bowels from an unspecified start date and ongoing from around 4-5 years as it helps with her bowels, felodipine (FELODIPINE ACTAVIS) taken for an unspecified indication from an unspecified start date and ongoing, for 30-40 years; rosuvastatin calcium (ROSUVASTATIN CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing; calcium, colecalciferol (CALCIUM PLUS D3) taken for bones from an unspecified start date and ongoing for 30 years once menopause started, for bones, famotidine (FAMOTIDINE) taken for an unspecified indication from an unspecified start date and ongoing, says she has been on this for maybe 4 years because she was eating a lot of Rolaids. The patient was also taking for concomitant Products Hair, nail, skin vitamin for hair, nail, and skin health and says her nails are nice and strong, she still has wrinkles, but she says that was part of being old. The patient also said flu shot in Sep2020, pneumonia shot, shingles shot on an unspecified date and had nothing. patient says the first shot was nothing, everything was fine, the second shot she was thinking this is good, everything is good, it was on 11MAR2021 but by 14Mar2021 she was in total fatigue, started to get an abscess on tooth, she doesn't think this was because of shot, she has a prostheses, fake hip, her hip was killing her where the actual bone joint was, she had had broken toe on the other foot, that was killing her, she had no energy at all. She says normally, she is 71 years old, she was very active. She says her doctor takes care of everything, in her case she is asthmatic, everything, he does all of her bloodwork. she has to get this tooth pulled, she had some cadaver teeth put in, she went to the gym, everything was great, all the sudden she has an abscess, she went to her periodontist who says it is bad, it needs to be pulled. She says she was going to get her tooth pulled tomorrow. She reports her shingles seemed to get aggravated, her doctor said she will always have this, when she gets upset, aggravated or anxious it flares up, she is now back on the gabapentin, it is like pins and needles under rib cage where the actual shingles were. She says she was asthmatic but it did not bother her lungs one bit, she did not have any lung issues. She says everything happened on 14MAR2021. She reports that she does find she gets tired, she cooked all day Saturday, she stood over the stove all day, she did nothing but that all day. She says her tooth was bright red, her whole cheek and still, she took the last antibiotics, a heavy dose, last dose this morning too. She reports her foot is not bothering her anymore, her hip is still a little sore. She says she can do 2 miles in the gym, it was hard to exercise with mask on, it is always cold, she can't walk, she's limited to what she can do right now. she said this what she has, almost like a fibromyalgia, she diagnosed herself as having this condition, she Googles it and it says its muscle pain, she doesn't have the strength that she had before, she doesn't have hand strength, stamina, to walk a mile killed her, now she can do 2 miles, she is not 100% of what she was, she's coming along though. prior Vaccinations (within 4 weeks); she got her flu shot in SEP2020; AE(s) following prior vaccinations: She says flu shot, pneumonia shot, shingles shot, and had nothing. The patient was recovering from fatigue and asthenia, not recovered from tooth abscess and shingles and rets of the events was unknown. No follow-up attempts are needed. No further information is expected.
71 2021-04-24 headache severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touc... Read more
severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touch; severe pain in her head, it hurt to touch and had shocks and her whole body would cramp up; her whole body would cramp up; Tourette's; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198, expiration date: 30Jun2021) at the age of 71-years-old, via an unspecified route of administration in right shoulder on 05Mar2021 at 10:30 at single dose for COVID-19 immunization. Medical history included neuropathy in feet caused Tamoxifen (chemotherapy), anal cancer stage IV, breast cancer, double mastectomy, chemotherapy, and lymph node in left arm. Concomitant medications included gabapentin, meloxicam, and vitamins. There were no additional vaccines administered on the same date with the COVID-19 vaccine as well as within 4 weeks. The patient previously took tamoxifen as chemotherapy and experienced neuropathy in feet. The patient received her first COVID-19 vaccine on 05Mar2021 and on 13Mar2021, she experienced severe pain across the front of her stomach. On 19Mar2021, she said she has something, and it was a rash. She went to care facility on 20Mar2021 and was told she has shingles. The patient stated that the doctor just looked at her and said she has shingles, no testing was done. They told her it was ok for her to get the second shot, but she was worried about that. She experienced shingles since 13Mar2021, she still has it. She was supposed to have the shingles vaccine 4 years ago, but it was expensive. Her son heard on the radio that the shot may cause shingles, it may or may not be related but she wanted to let Pfizer know. The rash was starting to go away, and the pain was not, but the pain was far better. She ended up going to the doctor on 24Mar2021 with severe pain in her head since Mar2021, and she didn't know why. It hurt to touch and had shocks and her whole body would cramp up. Her daughter told her she looked like she had Tourette's, it was happening every 2-5 minutes. The doctor couldn't do anything and told her what she could take. It was an additional thing and the doctor said it was probably from shingles but she did not have a rash there. It was completely gone now. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiration date: 31Jul2021), via an unspecified route of administration in right shoulder on 26Mar2021 at noon and stated that it was getting better then, and by 27Mar2021 it was gone completely. She was petrified this was going to happen while she was there to get the second vaccine and they would say she couldn't do it. The outcome of the event shingles was recovering and recovered on 27Mar2021 for all other events.
71 2021-04-27 headache, fever lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated;... Read more
lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated; weak; dizzy; nauseated; fever; headache; This is a spontaneous report from a contactable consumer (patient). This 71- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 11Mar2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was Public Health Clinic facility. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EN6200) dose 1 on 18Feb2021 04:00 PM, for covid-19 immunization, left arm. No known allergies. The medical history included: Blood pressure abnormal. Concomitant medications included: Prozac, Inderal, Atorvastatin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 09:00 am, Day after 2nd injection, she felt weak, dizzy, nauseated, fever, blood pressure elevated and had an extremely severe headache. That evening I lost partial vision in my right eye, which has been determined to be AION. Vision has not returned at one month out. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included: Blood pressure monitoring and return 13Apr2021. The clinical outcome of the events was not recovered. The patient was not tested for COVID-19 after the vaccination. No follow-up attempts are possible. No further information is expected.
71 2021-04-28 fever, malaise, fatigue, headache, runny nose muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain... Read more
muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain in left arm; pain in the joints; Red circle around injection site; Weak feeling in arms and legs; body feels heavy; dizziness; Very exhausted; Nausea; Diarrhea; Some cramping in stomach; Brain Fog; Body aches; headache; itchiness; Left arm sore at injection site; anxiety; not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Feb2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes diagnosed 15 years ago, obesity, asthma with bronchitis as a child, allergy to other medications, anaphylactic reaction to sulfas twenty years ago (also reported as 50 years ago), muscle hurt/sore arm usually when she got a flu vaccine (unspecified) once a year, allergies to makeup and clothes (diagnosed at least 50 years ago), heart beats fast, low thyroid and borderline high cholesterol. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for 30 years for low thyroid, nebivolol hydrochloride (BYSTOLIC) taken for 25 years, rosuvastatin calcium, (CRESTOR OD) taken for 2 years for borderline high cholesterol and insulin (unspecified). The patient did not receive any other vaccinations on the same day or within 4 weeks of the vaccine. The patient previously took paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as pre-medication since she had allergic reactions to some things and would get this before the flu shot; as well as salbutamol sulfate (PROAIR HFA) for runny nose and coughing. The patient had the first dose of the vaccine on 28Feb2021, and "they" wanted to give her diphenhydramine (BENADRYL) after the vaccine but could not since she was driving. After the vaccination, the patient was not feeling well for 2 days (as of an unspecified date) and thought she was getting better. On 28Feb2021, the patient experienced anxiety. She was more anxious when "that stuff" appeared on the news on day 4 and 5 after the vaccine. She took a small dose of clonazepam 0.5 mg, dividing the pill in 4 pieces as she never took the whole thing. She took it when she got extremely anxious and tried not to take it because it can be habit forming. She may take it 3 times a week or in the middle of the night. It helped a little bit, but she still felt panicky and upset. She woke up feeling anxious. She did not normally take these medications. The patient reported that she experienced headache (constantly several times a week) and left arm sore at injection site, itchiness/ itching all over body (not constant but still happening) from 28Feb2021. On Mar2021 (day 4), the patient experienced dizziness (comes and goes and was not constant like it was), was very exhausted, nausea (tapered off after 2 weeks), diarrhea, some cramping in stomach, brain fog (still struggling and forgets to take her insulin, not as bad as when she first noticed), body aches. At first, the body aches were a pain in the left knee and left elbow and then moved to various joints and muscles. The left knee and elbow pain persisted without ever going away, but also moved to different areas. The calf muscle in left leg pain is also constant. The patient experienced pain in the joints and stinging pain in left leg (below knee down to ankle) from 04Mar2021, runny nose (tapered off) from 07Mar2021, and on an unspecified date muscle pain, back pain, fever, neck pain, pain in left arm. On Mar2021 (two weeks after vaccination), the patient had a red circle around injection site not all the way filled in, but rim around where she got shot. On Mar2021 (3 weeks after vaccination), the patient experienced a weak feeling in arms and legs and other times when she stood up her body felt heavy (persistent but not every day). The patient spoke with her physician who did not believe the patient about the symptoms and recommended she seek psychiatric help. The patient had not received the second dose of the vaccine because her physician did not recommend it. She was upset because her physician told her she could not get the second shot. She was having worsening anxiety because she had not been feeling well for so long, going on 7 weeks. She visited her physician's office 6,7, or 8 times. The patient underwent lab tests and procedures on unspecified dates which included an ultrasound of the leg (did not have a blood clot), an X-Ray of the back (unknown results) and an MRI of the back (did not find anything) to determine the pain. The physician thought it might be a compression fracture, but the MRI did not show anything. The patient was tested for antibodies on 05Apr2021 and had zero antibodies. The clinical outcome of anxiety, felt panicky, neck pain was unknown; dizziness, headache, runny nose, itchiness, pain in the joints, muscle pain, back pain, fever, very exhausted, nausea, diarrhea, some cramping in stomach, brain fog, body aches, stinging pain in left leg / pain in left arm, weak feelings in arms and legs, body feels heavy, left arm sore at injection site, red circle around injection site, not feeling well, was resolving. No follow-up attempts are needed. Information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s): same patient, different vaccine dose/event
72 2021-01-04 chills arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she coul... Read more
arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she couldn't get warm at first and then she is cold; high blood pressure/blood pressure was high 190/116; big toes hurting; nausea; dizziness; feeling weakness legs/Leg feeling weak; This is a spontaneous report from a contactable other HCP reporting for herself. A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: CJ1686), via an unspecified route of administration in the right arm on 28Dec2020 15:00 at single dose for COVID-19 immunisation. Medical history included breast cancer on the left side, hypertension, hiatal hernia, glaucoma, heart disease, hypertension, lymphadenectomy (lymph nodes being taken out was about 20 years before) and headache from 27Dec2020. She was working Sunday into Monday morning and she went to the Director of Nursing, and said she has a Headache on the left side of the temple, and so she went to eye doctor, and he had a test order ESR and so she has a hemorrhage in the left eye, and show she doesn't know if this could be bringing on some of the side effects she was speaking about, like the nausea and the migraine. She has had No positive test for COVID prior to the vaccine, she must have had about 20 tests and all were negative. She has not had any Antibody tests. She had pneumonia vaccine maybe in the last 5-3 years and flu vaccine in Oct2020 and she experienced achy arm. On 28Dec2020 the patient experienced leg feeling weak (about 15 minutes after injection), nauseous at 21:00, dizziness. On 29Dec2020 the patient experienced arm hurting (in the morning), lymph nodes hurting on the left side, chills, blood pressure was high 190/116, big toes hurting. The patient was calling to ask if these side effects she was experiencing were normal. On 29Dec2020 the patient underwent ESR with unknown results. The patient reported that her arm hurting began on 29Dec2020 in the morning. The breast cancer diagnosis was prior to the vaccine as well as her lymph nodes being taken out was about 20 years ago. Her Lymph nodes hurting on the left side started on 29Dec2020 in the morning. Her Leg feeling weak started right after the injection, about 15 minutes after on 28Dec2020. The chills started on 29Dec2020 in the morning in which she couldn't get warm. Her feeling nauseous started on 28Dec2020 in the evening like 9 PM. The Temperature 98.1 was her current temperature taken right before the call, as well as her blood pressure. Her feeling dizzy started after getting vaccine on 28Dec2020, she was fine to drive home, but then again on 29Dec2020 in the morning she felt it also. Her legs felt funny like rubbery. The big toes hurting started an hour before, on 29Dec2020 it woke her up since it was jabbing. The outcome of the events was unknown.
72 2021-01-05 fever, chills, headache fever (101 highest) headache, chills
72 2021-01-07 chills, cough, fever, headache Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; E... Read more
Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; Every place I touched my head where a blood vessel ran is where the pain was; Terrible chills; Ran the temperature about a 100; Really bad headache; Slight soreness in my arm; Cough; Temporal arteritis; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. Medical history included sinus issues, allergy, hormone replacement therapy. Concomitant medication included estradiol as hormone replacement, metronidazole (METROGEL), vitamins and supplements. Patient stated, "I had the COVID injection 19Dec, the first one, afterwards there was a slight soreness in my arm to take couple of days, that was it, until this past Monday (28Dec2020) which was the 9th day afterwards, I started having chills, terrible chills, ran the temperature about a 100 and had a really bad headache. Woke up the next day (29Dec2020), I had noticed the blood vessels across my forehead were very enlarged like a big varicose vein and were very sore to the touch. I realized that my headache, every place I touched my head where a blood vessel ran is where the pain was. I've googled all my symptoms and the word that comes up when I read about is - Temporal arteritis. I didn't know if there was any possibility that was connected with that injection. Along with the chills and the fever, I had also had a cough and a headache." Patient stated, "I have been taking Ibuprofen two 200 mg tablets, once today and once last night" as treatment. The outcome of everts was not recovered.
72 2021-01-07 headache Day of injection - sore injection site Day 1 post injection - headache, nausea Day 2 post injection ... Read more
Day of injection - sore injection site Day 1 post injection - headache, nausea Day 2 post injection - nausea Day 3 post injection - increasing nausea, gas Day 4 post injection - Loose stool x 7, gas, nausea
72 2021-01-07 fever, cough, fatigue she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; ti... Read more
she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; tired; feels like she doesn't have enough energy; dry cough; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Dec2020, the patient experienced signs and symptoms of allergic reactions which was progressing. Mentioned that she had fever, fever with temperature ranging from 98.7°F-102.2°F, body ache, tired and feels like she doesn't have enough energy, dry cough. Wants to know how long does the symptoms last. The outcome of the events was unknown. Information about lot/batch number has been requested.
72 2021-01-08 chills Vomiting, Chills
72 2021-01-11 fever, chills Fever 101.9, chills, nausea, body aches, for a day (Thursday), felt better on Friday and ok on Satu... Read more
Fever 101.9, chills, nausea, body aches, for a day (Thursday), felt better on Friday and ok on Saturday.
72 2021-01-13 headache Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to... Read more
Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to her elbow; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; Nausea; total loss of appetite; stated that she gained 10lbs, but she is very physically active.; either not making blood or there was an interference; she was freezing/she woke up cold and could not get warm/ felt cold; she had a little headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021), intramuscular at left arm on 31Dec2020 at single dose for covid-19 prophylaxis. Medical history included low sodium, Covid-19 in Nov2020 (She had felt sick for a week and on 13Nov2020 she went to the ER and they did blood tests and she could not eat or drink for 3 days. She stated that she had 4 different IV fluids going and one of them was sodium and the other was for nausea), blood did not clot properly, broke her back. There were no concomitant medications.The patient had a unique reaction after receiving the Covid-19mRNA Vaccine. She clarified that she never had a reaction to a shot before. She received the vaccine on 31Dec2020 and was fine for the first 20 hours. She said that the next morning on 01Jan2021 at 0600 she woke up cold and could not get warm. She said that she spent the next 24 hours to where she kept adding clothes and blankets to keep warm. She stated that she was freezing and the she felt like the interior of her body was freezing even down to her toes felt cold. She also had injection site pain and the arm felt heavy and stated that the pain extended from her shoulder down to her elbow. She stated that the injection site pain was kind of delayed. She had aches and pains. She said that some of the pain went from the injection shoulder and spread to the middle of her spine. She had nausea and total loss of appetite and could not even eat. Her aches and pains after the vaccine were similar aches like she had with the Covid. She said that she had a terrible headache when she had Covid though. She stated that after the 24 hours of receiving the vaccine she had a little headache, but she took a migraine pill for it. She said that she was able to shed clothes, but she could not take a shower, but within 24-36 hours she was back to normal like it all never happened. She said that was when she figured out it was like her hemorrhaging with one of her childbirths. She explained that she had 3 children and hemorrhaged with each of her child births and was going into shock with one of them and felt this freezing sensation due to blood loss. She thought that her reaction to the vaccine was so bad that she was either not making blood or there was an interference. There was some kind of weird interruption. She said that her blood clots break down from minutes to hours after her child birth or with dental procedures. She had a PAI-1 deficiency or Plasminogen Activator Inhibitor-1 deficiency. She said that there was also something deeper that her doctors had not figured out yet too. She said that her blood did not clot properly. She said that she did not bruise or anything, but she was not allowed to have internal surgery without a transfusion. She said that her doctor's started to figure this all out after she broke her back before. She went to a hematologist and had her counts checked regularly. She said that she was being studied by 127 different clinics. She gained 10lbs, but she was very physically active. This was her first dose of teh vaccine. She said that her doctors told her that she needs to be under 48 hours of observation if she gets the second vaccine. Her primary care physician recommended that she did not take another mRNA vaccine. She said that she was taking their advice and canceled her second dose appointment. She said that when she had Covid-19 they did a Chest x-ray on 13Nov2020 and she had low sodium. She said that they gave her tramadol at the hospital for her headache, but she had already taken 3 migraine pills that day. She had already had her flu shot and read somewhere on a website, that mRNA vaccines might cause unstable anticoagulation. She wondered if it could be possible that Covid-19 antibodies interfered with her injection? The outcome of events was unknown.
72 2021-01-14 headache 2:15PM headache 10:30PM. Rash and itch on face trunk and under arms ... Read more
2:15PM headache 10:30PM. Rash and itch on face trunk and under arms Dry scratchy eyes , hazy vision Took Benadryl 25 mg at 10:45PM 1/15/2021. 9AM Rash subsided itch persists and eyes remain dry, scratchy and hazy vision gone 10 AM went to Dr
72 2021-01-14 headache Abdominal cramping, belly ache, nausea, diarrhea, headache in the night. Queasy in the morning. Sl... Read more
Abdominal cramping, belly ache, nausea, diarrhea, headache in the night. Queasy in the morning. Sluggish. Bland diet - rest. It seems to be resolving.
72 2021-01-14 fatigue, headache At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has con... Read more
At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has continued with occasional spreading to nose & eyes & sometimes on other side of face - it waxes & wanes Same day - headache, dizzy, exhausted - lasted 2 days Next day - nausea, intestinal discomfort - continuing mildly Mild headache continuing
72 2021-01-14 fatigue The text phone contacts to me have not worked for past two days. My symptoms now are fatigue, genera... Read more
The text phone contacts to me have not worked for past two days. My symptoms now are fatigue, general achy joints and muscles, slight swelling and pain at the injection site. I am fine but need help with the survey sent via text does not work. Unable to "Do your weekly post-vaccination check in".
72 2021-01-17 fatigue After waking in the AM of the following morning after vaccination, felt total exhaustion and weakne... Read more
After waking in the AM of the following morning after vaccination, felt total exhaustion and weakness, unable to function with morning duties, left arm sore with a notable lump approximately 2 inches wide. Able to lie down and sleep for about an hour; awoke and felt better. Took two 200mg ibuprofen and laid down again. Within an hour of rest, felt awake with no weakness or exhaustion. Arm was less sore; however placed a warm heating pad on arm throughout the day which improved the lump and soreness.
72 2021-01-18 chills, fever Low grade fever, chills, joint and muscle pain.
72 2021-01-18 lethargy, fever, chills joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (1... Read more
joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (100.6); hypotension; hypoglycemia; lethargy; the 2nd dose on 08Jan2021 /1st dose on 20Dec2020; This is a spontaneous report from a contactable Physician (patient). This 72-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 08Jan2021 05:00 PM at single dose (lot number: EK9231) for covid-19 immunisation. Medical history included diabetes, idiopathic encapsulating peritonitis and known allergies to Latex. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), tamoxifen, apixaban (ELIQUIS), simvastatin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at left arm on 20Dec2020 01:00 PM for covid-19 immunisation. The patient experienced chills began 19 hours after injection, followed by low-grade fever (100.6), hypotension, hypoglycemia, lethargy, confusion and anorexia on 09Jan2021 12: 00 PM. Illness lasted 17 hours, treated with fluids, anti- inflammatories and sleep. Some new joint pain persisted. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event joint pain persisted was unknown. Outcome of other events was recovered/resolved with sequel.
72 2021-01-19 fatigue, sweating Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heavi... Read more
Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heaviness in chest rated at 7/10 pain scale, mandibular pain, appeared diaphoretic and fatigued, skin grey/pale, though remained alert and responsive to questions appropriately. Patient also communicates she was having some chest pain prior to the immunization today, though she indicated on her forms that she was feeling well today. Vital signs assessed, P72 R16 O2 99, patient denied difficulty breathing. Rapid response protocol initiated, applied 2L O2 via NC, transferred patient to wheelchair and taken to ED for evaluation by response team. ED assessment reveals calf tenderness and patient reporting TKA x 2 weeks ago, elevated D-Dimer, CT results pending at this time.
72 2021-01-19 fatigue, malaise, runny nose, sneezing Sneezing,, stuffy, runny nose, and fatigue and malaise.
72 2021-01-20 malaise Community member receiving covid vaccine c/o abd discomfort and urge to defecate with left arm itchi... Read more
Community member receiving covid vaccine c/o abd discomfort and urge to defecate with left arm itching (vaccine receive in right arm). Escorted to bathroom without incident, no rash noted to either arm. Escorted back to monitoring area where approx 15 min later she continued to c/o abd discomfort and "crumminess." ED Charge RN contacted, ED staff transported patient via wheelchair to ED.
72 2021-01-21 chills 3PM BURNING SENSATION IN THE EYES; DRY MOUTH; CHILLS/NO FEVER
72 2021-01-21 headache Patient had an increase in chronic headache frequency and had a near-syncopal episode on 1/21/21. Sh... Read more
Patient had an increase in chronic headache frequency and had a near-syncopal episode on 1/21/21. She stated that the near-syncopal episode lasted for about 10 minutes. She has had one prior episode that was caused by hypotension and dehydration.
72 2021-01-23 fever, fatigue sore arm, slight fever, extreme fatigue. lasted most of the day and they are gone now.
72 2021-01-24 headache, cough, chills 1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after t... Read more
1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after the steroid shot, I started reactions---Severe headache, chills, nausea, cough, upper chest pain, severe weakness, blood pressure up and down. Went to family doctor 1/22 and covid shot in office showed negative. Worse on 1/24/21 and went to ED. They did a chest x-ray, CTA chest, lots of bloodwork and covid test that took 2 hours to receive results. All was negative except the D-dimer test. Thye thought it might be a result of the 2 injections within days of each other.
72 2021-01-24 chills Chills Body Aches Soreness at Injection Site
72 2021-01-24 fatigue, chills, fever Injection site pain, tiredness, muscle ache, chills, fever 100.1
72 2021-01-24 fever, headache, chills chills, low grade fever, aches, pain in arm, slight nausea, headache started about 12 hours after re... Read more
chills, low grade fever, aches, pain in arm, slight nausea, headache started about 12 hours after receiving shot lessening after about 48 hours
72 2021-01-24 malaise, chills, headache leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after inj... Read more
leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after injection & still have malaise and nausea. Had headache yesterday and day before. Also woke up at 3AM yesterday and day before in a cold sweat. Some leg ache today as well. Have been taking 2 extra strength Tylenol every 6 hrs which sometimes gives relief but not always.
72 2021-01-25 fatigue, headache At vaccine site, had numbness; tingling on lips and tongue on left side of face; tingling on left si... Read more
At vaccine site, had numbness; tingling on lips and tongue on left side of face; tingling on left side of face; headache/Mild headache; dizzy; exhausted; GI - mild naseau; intestinal discomfort; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL32216), via an unspecified route of administration on 09Jan2021 10:00 at SINGLE DOSE at arm left for covid-19 immunisation. Medical history included known allergies: yes. Concomitant medications included levothyroxine sodium (SYNTHYROID), lisinopril, fexofenadine hydrochloride (ALLEGRA), progesterone (PROMETRIUM [PROGESTERONE]), and "PULMICO". On 09Jan2021, it was reported that At vaccine site, had numbness, tingling on lips and tongue on left side of face. This has not subsided, sometimes spreading, waxing & waning. Same day - headache, dizzy, exhausted - two days. GI - mild naseau (nausea), intestinal discomfort - on going. Mild headache continuing. The patient did not receive treatment for the events. The outcome of the events was reported as recovering.
72 2021-01-25 sneezing, sneezing Experiencing vision blurriness, dry eyes, - utilizes eye drops and resolves. Feels "heavy" some sne... Read more
Experiencing vision blurriness, dry eyes, - utilizes eye drops and resolves. Feels "heavy" some sneezing too.
72 2021-01-26 headache, sleepiness Drowsiness and headache. I slept three hours after I arrived home from 2:30-5:30 and took tylenol... Read more
Drowsiness and headache. I slept three hours after I arrived home from 2:30-5:30 and took tylenol.
72 2021-01-26 headache Severe Headache - for 2 days and took Tylenol, Face Swelling - for 1 day and took Benadryl, ... Read more
Severe Headache - for 2 days and took Tylenol, Face Swelling - for 1 day and took Benadryl, Diarrhea - for 1 day, Arm swollen and hot, - for 1 day, Body muscle pain - for 3 days
72 2021-01-26 chills extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This ... Read more
extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This is a spontaneous report from a contactable consumer report self. This 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at right arm on 12Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included had COVID back in Nov2020, blood cholesterol abnormal. Concomitant medication included Pravastatin for blood cholesterol and unspecified water pill. No prior vaccinations within 4 weeks. No additional vaccines administered on same date. Patient received Pfizer covid vaccine on 12Jan2021 around 15:30. Her right arms started getting in pain about 11pm and the pain prevented her from sleeping most of the night till she took an Aleve around 6am. She took another Aleve on 13Jan2021. She can barely raise her right arm and it is ok if she does not try to use it but if she tried to use her right arm then it is inoperable. At 12Jan2021 night after she got the vaccine she experienced itching, she never got a rash, the itching never got bad and it went away. She has not taken her temperature. She was having extreme chills that started around 13Jan2021 3:00 pm and she cannot get warm, she has blankets piled on her. Her neck is aching (started 13Jan2021 afternoon) and she thought this may be from tensing up since she is cold. No emergency room or physician office visit. The outcome of "Itching" was recovered, of else events was unknown. Information on the lot/batch number has been requested.
72 2021-01-27 fatigue, headache 1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day he... Read more
1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day headache, nausea, mind fog and imbalance, 6th day ulcers on my tongue, very painful for 3 days, severe crippling muscle cramps in my toes on my right foot during the night while sleeping. hives and red blotches. I didn't feel like myself for at least 12 days after the vaccine. I'm a little nervous about today, 01/28/2021, I took my 2nd dose this morning. Hope I don't have to report anything on the 2nd.
72 2021-01-27 headache DROOPING ON RIGHT SIDE OF FACE, EYE LID, RIGHT CHECK, RIGHT SIDE OF MOUTH, HEADACHE N SOME RIGHT EAR... Read more
DROOPING ON RIGHT SIDE OF FACE, EYE LID, RIGHT CHECK, RIGHT SIDE OF MOUTH, HEADACHE N SOME RIGHT EAR DISCOMFORT, EYE IRRITATION. CAT SCAN DONE AND ALL SHOWED OK AND THE FINAL OUTCOME ITS BELLS PALSY
72 2021-01-27 fatigue Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished m... Read more
Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished meal I started to get double over pain we went home and that took 15 min. The pain was sharp and continues for a total of 30 min. I payed down with heat pad then it went away .since then I feel very tired, no energy,and my arm still feels weak and sore after the first shot .today I go for the second one.
72 2021-01-28 fatigue, sweating 12 minutes after receiving shot began to feel sweaty and light headed and like I was going to faint ... Read more
12 minutes after receiving shot began to feel sweaty and light headed and like I was going to faint - felt like something was going on with my heart.
72 2021-01-28 chills Sever shakes and chilled to the bone. Fingers went numb with being so cold.
72 2021-01-28 headache, malaise pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like he... Read more
pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like her head is big; she didn't feel good; headache; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular on 14Jan2021 12:00 at a single dose on left arm for COVID-19 immunization. Age at vaccination: 72 years old. Medical history included hypertension, infection (term highlighted by the reporter: Yes; patient was admitted to a hospital from 29Dec2020 to 30Dec2020 due to infection), dyspepsia (reported as stomach, digestion), psoriatic inflammatory arthritis (she receives infusions for her arthritis once a month), sinus infection/sinus problems a month or two months ago, had cancer back in 1996 (had lumpectomy), stomach problems, and gastric endoscopy. Ongoing concomitant medications included losartan potassium, hydrochlorothiazide, omeprazole, and methotrexate. Other concomitant medications included folic acid, and plantago ovata (METAMUCIL). The patient had a regular flu shot a month ago (Dec2020). She can't remember when. The patient experienced headache on 14Jan2021. At the beginning, she had one, but then she got home, and the headache was like in the back of her head, like in her neck. She had pain all around her neck. She was feeling dizzy. She was able to sleep, however, the pain in her head is still there. She took aspirin along with her regular medication. When providing details, the patient made the comment that she can't think straight. She also has sinus problems, so she doesn't know if she has a headache from the sinus problems or because of the shot. She doesn't have a fever. She just feels like her head is big. She sees the date of when she is supposed to return for her second vaccine, 04Feb2021. She sees the lot number and then it has (name of center). The actual dose is unknown, she knows this is her first dose. She also receives infusions for her arthritis. She receives an infusion at a facility once a month, she used to receive it less than that, but her arthritis has been really bad, so she now does it once a month. She was supposed to go today but she didn't go because she didn't feel good. She had three COVID tests done because she had the sinus situation going on. A COVID test was done yesterday (14Jan2021) and it was negative. Another one was done when she had a gastric endoscopy on 09Dec2020. This test was also negative. She doesn't remember if she had another one in Dec2020 when she was at the emergency center, but all of her COVID tests have been negative. The patient has not recovered from headache. Outcome of the rest of the events was unknown.
72 2021-01-31 headache Headache, upset stomach, nausea and diarrhea, and her face was sunburn red and started Friday the 29... Read more
Headache, upset stomach, nausea and diarrhea, and her face was sunburn red and started Friday the 29th and still sick. throwing up every 15 to 20 mins. Called Dr. on Sunday and was told to take aspirin and Tylenol
72 2021-01-31 headache Itching/itchy/back was itching like crazy; her shoulder and it was red and it looked like a hive/lik... Read more
Itching/itchy/back was itching like crazy; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; Slight, dull headache; son sprayed her back with a fragranced alcohol and and it started burning; she thought it was a mosquito bite; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), intramuscularly on 06Jan2021 at about 13:00 at single dose in Left arm for COVID-19. There were no medical history and no concomitant medications. She was not allergic to anything. The patient previously took shingles vaccine for immunization before. The patient reported that in the middle of the week (in Jan2021) she started feeling itchy. She said that she did not take anything and never took the flu shot. She was itching so bad last night (on 17Jan2021) she was going nuts. Her doctor told her get BENADRYL. She looked at her shoulder and it was red and it looked like a hive. She said that 5 minutes later and it went away without her taking her BENADRYL. She took the BENADRYL dose that she picked up from and that put her out. She stated that she took 10ml. She was a little itchy. She stated that if you look at the area on her shoulder, it was like pinpoint little dots now and you can barely see it. She said that this happened in the same shoulder where she received the vaccine. She said that she w supposed to get the next one next Wednesday. The patient asked if this was a side effect or just a coincidence. She stated that her symptoms started about a week after the shot sometime, but she did not know the exact day. It was around 13Jan2021 or 14Jan2021. It happened in a matter of seconds and she thought she was seeing things, then it went away. It was red and raised and was gone within 5 minutes at the most. It was weird. She said that she thought it was a mosquito bite. The patient stated that her back was itching like crazy. She stated that she put alcohol on it and it went away. Her son sprayed her back with a fragranced alcohol and it started burning. She also had a slight dull headache in Jan2021 and she had never had that in her life. The outcome of events her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine was recovered in Jan2021. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
72 2021-01-31 headache, fever On day following shot, I became achy all over, had a headache and slight fever. I went home from my ... Read more
On day following shot, I became achy all over, had a headache and slight fever. I went home from my shopping trip, took a 3 hour nap. I felt worse so I went to bed and slept 14 hours. I felt better Saturday morning. That evening I noticed a rash on both legs, from ankles to my knees. It is still there, though it doesn't itch or make me feel sick.
72 2021-01-31 fatigue, fever, chills chills, fever, nausea, fatigue, body aches for six days so far
72 2021-01-31 fever severe muscle cramps , muscle fatigue , low grade temp
72 2021-02-01 malaise, sleepiness, lethargy, influenza like illness, fatigue Felt like had the flu; Lethargic; Nauseated/ Nausea; overall unwell feeling, she did not feel well a... Read more
Felt like had the flu; Lethargic; Nauseated/ Nausea; overall unwell feeling, she did not feel well at all; she slept constantly/sleeping; Tiredness; did not eat; felt like throwing up; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ELI283) via an unspecified route of administration on the left arm on 15Jan2021 10:15 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She mentioned she felt nauseated on 15Jan2021. She woke on 16Jan2021 and felt like she had the flu. From Friday until Sunday like until 12:45 she slept constantly. She experienced tiredness. She did not eat. She was just sleeping and felt like throwing up (Jan2021). She started the feel the nausea the same day she got the vaccine. She blew it off thinking it was nothing. However, the next morning she felt like she had the flu. She was feeling lethargic. The nausea went away yesterday afternoon. On 19Jan2021 was the first day she felt like herself. She felt like she had the flu soon as she woke up. She had this overall unwell feeling, she did not feel well at all in Jan2021. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to the emergency room and physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. The patient recovered from the events nauseated/ nausea and felt like had the flu on 18Jan2021; lethargic on 19Jan2021. Outcome of the other events was unknown.
72 2021-02-01 runny nose, fever dizziness; aches; fever; sniffles; pain at injection site; This is a spontaneous report from a conta... Read more
dizziness; aches; fever; sniffles; pain at injection site; This is a spontaneous report from a contactable health care professional (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested) via an unspecified route of administration on 13Jan2021 at 07:00 PM on the left arm at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergies to eggs both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not have COVID-19 prior to vaccination. It was reported that on 14Jan2021 at 07:00 AM, 12 hours after the vaccine, the patient experienced dizziness, aches, fever, sniffles and pain at injection site. The outcome of the events was recovered on an unspecified date in Jan2021. The patient did not receive any treatment for the events. The patient has not been tested for COVID-19 post vaccination. Information on the lot/batch number has been requested.
72 2021-02-03 chills, fatigue, headache Fatigue, headache, chills, aches in extremities.
72 2021-02-03 sweating go to the bathroom, remember wiping and them my husband standing over me on the floor; Sweating prof... Read more
go to the bathroom, remember wiping and them my husband standing over me on the floor; Sweating profusel; Product use for unapproved combination; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) via an unspecified route of administration in the right arm on 19Jan2021 at 09:15 at single dose for COVID-19 immunisation. The patient was not pregnant. She received another vaccine (unspecified) in the left forearm on the same date of BNT162B2. Relevant medical history included allergies to tape and potential basal cell cancer. Concomitant medications included melatonin and multi vitamins. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 21Dec2020, second dose in the left arm. The patient reported that she felt great after the shot at 9:30 am on 19Jan2021 and, at 13:30, she had a potential basil cell cancer removed, and she felt great. On 20Jan2021, at 1:55 am, she got up to go to the bathroom, she remembered wiping and then her husband standing over her on the floor. On 20Jan2021 at 01:45 am, she was sweating profusely; after a minute, she got herself off the floor, back in bed, and she had no feelings of any illness. The patient did not receive corrective treatments for the reported events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered from the events on an unspecified date.
72 2021-02-03 headache, lethargy, cough positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt ... Read more
positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt lethargic and had a dull headache; Her arm hurt the night of the vaccine and the following day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient) reported similar events for two patients (patient's husband and patient). This is the first of two reports. A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot EH9899), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. Medical history included cholesterol. Concomitant medication included pravastatin sodium (PRAVACOR) for cholesterol, levothyroxine sodium (SYNTHROID), she had been taking both at least 10 years and were ongoing. The patient experienced her arm hurt the night of the vaccine and the following day since 04Jan2021. She had been tested a few times. Tested in (state) and then came to (state). Quarantined for two weeks and test were negative. She had COVID testing on 11Jan2021 and got results were 13Jan2021. She experienced positive for covid on 11Jan2021, cough and she felt lethargic and had a dull headache on 06Jan2021, she had a mild case, did not have a fever, she went to the walk in clinic, had lungs checked, her oxygen level was normal, she had been testing normal, she did not have any severe symptoms of the COVID, she got post nasal drip and She started Azithromycin on 11Jan2021. The patient was such a careful person. When she went to the supermarket, she wore a shield, mask, and gloves. She did not socialize, was home body. She had no idea how she got it. She did call her internist when she found out she had it. The patient underwent lab tests and procedures which included oxygen level: normal in Jan2021, oxygen level: good on an unknown date, COVID test: negative on an unknown date, COVID test: positive on 11Jan2021, lung checked: clear in Jan2021, testing: normal in Jan2021. The even outcome was unknown.
72 2021-02-03 fatigue tends to have low blood pressure; Dizziness; she lies down and then gets up she is dizzy; tired; she... Read more
tends to have low blood pressure; Dizziness; she lies down and then gets up she is dizzy; tired; she might have almost fainted as the room was spinning; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284, expiration date 0Apr2021), via an unspecified route of administration in the left arm on 18Jan2021 at 09:30 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history included Reflux esophagitis, COPD and a root canal on 14Jan2021. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020. Past drug history includes sore arm after COVID-19 vaccination on 28Dec2020. It was unknown if the patient has any allergies to medications, food, or other products. The patient's concomitant medications included oral famotidine (FAMOTIDINE) 20mg twice daily for reflux, (tiotropium bromide) SPIRIVA 2.5mcg, two puffs once daily by mouth for COPD, latanaprost (LATANAPROST)125mcg; one drop each eye at night for Glaucoma, (TIMOLOL) 5% one drop twice daily to each eye and (LORATADINE) 10mg; take once daily by mouth as needed for allergy. The patient did not receive any other vaccine within four (4) weeks prior to the vaccine. The vaccine was administered to the patient at the hospital. On 19Jan2021 the patient experienced dizziness and feeling tired. The patient further described that she had the vaccine on Monday and since yesterday, when she woke up, she has a lot of dizziness; and again this morning when she woke up. Also, when she lies down and then gets up she is dizzy. Mentions she didn't see dizziness on the list of side effects. She knows that is a side effect of COVID. She is asking is dizziness is a side effect of the vaccine wants to know if she should call her doctor. She continued and mentioned that she noticed when she was waking up on 19Jan2021 she was so dizzy that she couldn't get out of bed. Adds she thinks she might have almost fainted as the room was spinning. Mentions she tends to have low blood pressure but this is not typical. As far as side effects from the vaccine she mentions she is tired. The tiredness started after the second dose and has continued through today but not as bad. The clinical outcome of dizziness was reported as not recovered, the outcome of fatigue was recovering and the outcome of almost fainted and low blood pressure was unknown.
72 2021-02-04 chills Chills, severe muscle aches, injection site irritation.
72 2021-02-04 headache Headache, fuzziness, and overall weakness that kept me in bed for 1 1/2 days. No fever. Took Tylenol... Read more
Headache, fuzziness, and overall weakness that kept me in bed for 1 1/2 days. No fever. Took Tylenol and Metamizole..
72 2021-02-04 chills, fatigue body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a sponta... Read more
body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the right arm on 16Jan2021 at 18:15 at a single dose for COVID-19 immunization. The vaccination facility was a public health department. The vaccine was not administered at the Military facility. The patient had no additional vaccines administered on the same date of the Pfizer vaccine. Relevant medical history included gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. The patient had no family medical history. Concomitant medication included cimetidine for GERD, which she had been taking for years and years. The patient had no other vaccinations within four weeks prior to the first vaccination. The patient woke up on Tuesday, 19Jan2021, feeling off; she experienced body aches, joint pain, and fatigues. The symptoms (Sxs) were still ongoing. The patient had question regarding the side effects and duration: if these had been reported and was it normal to still feel the side effects and how long would it last for. The patient was also asking if these were indicative of something more serious. The patient added that her healthcare provider (hcp) told her to take 2 paracetamol (TYLENOL) every 6 hours; however, the Tylenol only lasted for 5 hours. The patient further asked that if she continued to have side effects, at what point should she be do something and wanting recommendations on management. The patient was also asking if the side effects would happen with the second shot. The patient further reported that she felt pretty good on Sunday and Monday (17Jan2021 and 18Jan2021), maybe just a little off, and stated that on Tuesday (19Jan2021), she woke up and started with the classic side effects body aches, joint pain, fatigue, and chills that had continued. She stated she was taking Tylenol 2 extra strength; it worked for about 5 hours and then the effects came back. The patient wanted to know if this was normal to last this long and had this been reported by others. She stated she had contacted her doctor and her doctor did not know. The adverse events did not require any visit to an emergency room or a physician office. Therapeutic measures were taken as a result of body aches/ body and legs aches, joint pain, fatigues, and chills. There were no relevant tests. The patient was not recovered from the events "body aches/ body and legs aches, joint pain, fatigues, and chills."
72 2021-02-04 influenza like illness muscle aches, flu-like symptoms lost taste and smell 2/1/21
72 2021-02-05 chills, sweating Awakened by terrible chills, nausea, and sweats.
72 2021-02-05 fever, fatigue, headache Extreme fatigue, headache, fever 100.2, joint pain at injection site
72 2021-02-05 headache Pfizer-BioNTech COVID-19 Vaccine EUA Laughing uncontrollably, slurring of words, headache, foggines... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Laughing uncontrollably, slurring of words, headache, fogginess. Event lasted about one hour.
72 2021-02-07 chills 14 hours after the injection I woke up and my teeth were hitting each other. I was not cold or hot. ... Read more
14 hours after the injection I woke up and my teeth were hitting each other. I was not cold or hot. Within a few minutes my body muscles began twitching uncontrolably. My arm,, legs,, jaw were all fluttering.. This lasted for one hour.
72 2021-02-09 headache, fever Fever; Headache; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient... Read more
Fever; Headache; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. This 72-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: Unknown), via an unspecified route of administration on 15Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 20Jan2021, the patient experienced fever, headache and vomiting 5 days after vaccination. No therapeutic measures were taken as a result of the events. The clinical outcomes of the fever, headache and vomiting were resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
72 2021-02-09 fever On my drive home, my face started burning. When I arrived at home the burning increased with redness... Read more
On my drive home, my face started burning. When I arrived at home the burning increased with redness I reported this information on Tuesday 1/26/21 to the provider of the vaccine. I was told to take Benadryl which I did immediately. On Wednesday, I continued to take Benadryl every 4 hours. On Thursday, my face continued to burn with redness and a rash. I then started to get a low grade fever and it appeared my face was swelling and then we decided to go to Urgent Care. The Doctor said my face was swollen and gave me a 1/2 dose of a steroid shot and a prescription for steroid pills. I saw my Primary Care Doctor 2/8/21 and he said I should not get the second dose of the vaccine.
72 2021-02-09 headache, fatigue, chills, malaise, body temperature increased Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, chills, nausea, vomit, feeling unwell, di... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, chills, nausea, vomit, feeling unwell, dizziness and weakness
72 2021-02-09 headache Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported dizziness, diplopia... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported dizziness, diplopia, headache, and difficulty with answering questions. Denies chest and abdominal pain and shortness of breath. Patient transported to the emergency department where initial vital signs within normal ranges except blood pressure 170/119 mmHg. Physical and neurlogical exam noted above symptoms with cranial nerves, sensation, and extremty strength intact/normal. Patient's symptoms rapidly resolved without intervention. Repeat vital signs within normal ranges except blood pressure 134/91 mmHg. Determined patient experienced a vasovagal episode. Patient discharged to home stable.
72 2021-02-09 pneumonia, chills, sweating, malaise, fever Started feeling unwell several days after shot. Chills fever soaked bed sheets and had to call in s... Read more
Started feeling unwell several days after shot. Chills fever soaked bed sheets and had to call in sick from work. Did telehealth visit with primary who recommended Covid test which came back negative. Primary advised going to Hospital emergency room for tests-she has been in hospital with pnemonia for 14 days and is now in ICU. Drs treating with high dose steroids, antibiotics and high dose oxygen. She is not recovering.
72 2021-02-09 nasopharyngitis allergy; cold; heart rate went up to 127, then stayed in the mid 80's; This is a spontaneous report ... Read more
allergy; cold; heart rate went up to 127, then stayed in the mid 80's; This is a spontaneous report from a contactable consumer (patient). This a 72-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date: not reported), via an unspecified route of administration, on 22Jan2021 03:45 PM at a single dose on the right arm for COVID-19 immunization. The patient was not pregnant. The patient had not received other vaccines in four weeks prior to receiving bnt162b2. Medical history included Hashimoto's, and allergy to statins and fluoroquinolones. The patient had no covid prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL). The patient also received another vaccine (unspecified), first dose on 22Jan2021 on the right arm. At about 12:30 or 1:00 pm on Saturday, 23Jan2021, the patient's heart rate went up to 127, then stayed in the mid 80's. She felt like she had an allergy or a cold all of a sudden. She had to rest for a few hours. By 4 pm she felt better. The patient was not tested for covid post vaccination. The patient did not receive any treatment. Outcome of the events was recovered on an unspecified date in Jan2021. Information on the Batch/Lot number has been requested.
72 2021-02-10 throat irritation, headache, fatigue Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue... Read more
Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated "I was completely aware though a little "foggy". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came. Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned." Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
72 2021-02-10 headache This was scary like waking up with Bells palsy/her neck froze up/when she woke up she could not look... Read more
This was scary like waking up with Bells palsy/her neck froze up/when she woke up she could not look up, down, left or right/It was like her neck was frozen or paralyzed, the muscles would not move; the muscles would not move/She was doing anything to loosen the muscles; shooting pain in her head; She was in a lot of pain in her head and neck.; her neurologist confirmed it was a muscle issue; This is a spontaneous report from a contactable consumer who reported for herself, a 72-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration in the left arm, on 21Jan2021 at the age of 72 years, at around 16:00 at a single dose for COVID-19 immunization. Medical history included her left eye had a virus that was finally taken care of back in Mar2020 but took a year and a half to heal. She had 5 surgery on that eye from an unspecified date. Also, her left lymph node got filled with fluid and was swollen but the doctors were not concerned about it. She would see an ENT for this. The patient has been seeing a neurologist who has done brain scans and MRI's due to the loss of peripheral vision do to eye problems. The patient has no allergies and is basically healthy. Concomitant medications include unspecified "natural stuff". The reporter stated she had a pretty bad reaction with the vaccine and it took 3 days to get over, her neck froze up. She woke on 22Jan2021 with the frozen neck. She got the first shot on Thursday, 21Jan2021, and on Friday morning, 22Jan2021, when she woke up she could not look up, down, left or right. It was like her neck was frozen or paralyzed, the muscles would not move. Any effort to move her neck would send shooting pain in her head. She applied a heating pad, took Aleve, she took a couple of them, a massager, biofreeze, and stayed in bed. She was doing anything to loosen the muscles. The next morning she was able to look up and down but still not left or right. She did the same thing for treatment that day. On Sunday, 24Jan2021, she was better, was able to move her head 3 of 4 directions. She continued with the treatment she had been using and by Monday, 25Jan2021, her muscles loosed up and her neck worked again. She was sure it is muscles and when she called her neurologist confirmed it was a muscle issue. She was in a lot of pain in her head and neck. The patient was under care for her neck and head and wondered if this happened because this was a weak area, she did not know if related. The patient remarked she was scared to get the second dose due to the problems she had with the first. She heard that the second dose was the one with worse side effects. She was in bed 3 days with this first one. It was reported that the events did not require a visit to Emergency Room, and required visit to physician office. Patient called the neurologist due to the pain and was told to go to acute care to evaluate but she didn't go. The patient stated that this was scary like waking up with Bells palsy and was wondering if she would ever get better. She has never had anything like this happen to her before. She has to be attributed it to the shot. The patient needed guidance on getting the second dose, and had questions about side effects. The outcome of the events was recovering. Information on the Batch/Lot number has been requested.
72 2021-02-14 fever Low grade fever; heart palpitations; This is a spontaneous report from a contactable consumer (patie... Read more
Low grade fever; heart palpitations; This is a spontaneous report from a contactable consumer (patient) A 72-years-old no pregnant female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# El9262 on 27Jan2021 (at age of 72 years old ) in the right arm 08:30 at SINGLE DOSE for covid-19 immunisation . First dose received on 06jan2021 (lot#EI3246) 10:30 in the right arm .The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered:Other. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced low grade fever and heart palpitationson 28Jan2021 07:00 .Events were reported as non serious.No treatment received .Outcome of the events was recovered.No Prior to vaccination, was the patient diagnosed with COVID-19.Since the vaccination, the patient had been tested for COVID-19.
72 2021-02-14 throat pain, headache headaches; Sore throat; This is a spontaneous report from a contactable consumer (reporting for a pa... Read more
headaches; Sore throat; This is a spontaneous report from a contactable consumer (reporting for a patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),lot number unknown, via an unspecified route of administration on 21Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced headaches and sore throat on 24Jan2021 (also reported as "headaches days 3-6 post-vaccination, Sore throat starting day 6"). The outcome of events was not recovered. Patient did not receive any treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been requested.
72 2021-02-16 headache, fever, throat pain, chills Developed Covid 19 7 days after receiving 1st vaccine. Sore throat, chills, fever, body aches, head... Read more
Developed Covid 19 7 days after receiving 1st vaccine. Sore throat, chills, fever, body aches, headaches.
72 2021-02-20 malaise On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontan... Read more
On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontaneously resolved while staff was telling me how they would treat it. Gave me Metoprolol 5 mg IV with 500 IV fluids and discharged. Then on 2/6/21 I slept poorly and felt very jittery and had more chest pressure but pulse was regular. then on 2/8/21 at 6:00 am I awoke and felt terrible with chest pressure. Took my blood pressure at home and it was 193/103, and I was very shaky. Went to ER where they did blood work, X-ray, and monitored my heart and blood pressure for 4 hrs. Gradually my blood pressure came down, and my blood work and X-ray probed to be WNL. I was discharged without medication change but had echocardiogram scheduled and follow-up appt. with Cardiologist, on zoom. He started me on Flecainide 100 mg bid, and stress test on 2/24/21 and follow-up appt. with him on 3/3/21. I also had a follow-up appt. with my GP the day after the first ER visit and she ordered more labs, and the echocardiogram. I have continued to have feelings of fluttering and pressure in my chest off and on and they continued after my second vaccine. But my heart has remained regular since starting the Flecainide. But my blood pressure went up to 150/85 on 2/9/21 and again to 142/81 on 2/10/21 both times with feelings of jitteriness and pressure in my chest.
72 2021-02-21 sweating Pfizer-BioNTech COVID-19 Vaccine EUA: immediately after receiving vaccination patient reported dizzi... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: immediately after receiving vaccination patient reported dizziness, tremors, diaphoresis, and numbness and tingling of legs. Medical emergency team called to evaluate patient. Vital signs checked four times throughout observation period and all were within normal ranges. Patient's symptoms improved with food and juice and able to leave vaccine clinic for home asymptomatic and stable.
72 2021-02-21 malaise, fatigue, headache, chills the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredne... Read more
the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
72 2021-02-21 headache tingling on top of her ears, headaches, possible rash on top of her hands that resembled prior histo... Read more
tingling on top of her ears, headaches, possible rash on top of her hands that resembled prior history of contact dermatits
72 2021-02-21 fatigue, headache very achy muscles, headache lasted over a week, tired
72 2021-02-22 fever Emergency room 1/11/21 Patient is a 72 year old female who presents with decreased level of consci... Read more
Emergency room 1/11/21 Patient is a 72 year old female who presents with decreased level of consciousness. The patient is a nursing home patient and had an episode of choking yesterday that was treated with a Heimlich maneuver. Nursing staff at the nursing home reports that she seems to be a bit less responsive today. However, the patient has been for the most part unresponsive for 3-4 months time following a COVID-19 infection. Of note, her oxygen saturation on room air is 72%. The patient is also febrile to 100.8°. She was unable to provide any information and the aforementioned information is gathered from nursing home staff report.
72 2021-02-22 runny nose, fever, throat pain, chills, headache, cough angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy... Read more
angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy; muscle aches and heaviness; muscle aches and heaviness; she just woke up feeling sick; fevers may come like a hot flash; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown), via an unspecified route of administration on 23Jan2021 at a single dose, in left arm for COVID-19 immunization. Medical history included fibromyalgia diagnosed years ago, angina (some stents). There were no concomitant medications. On Jan2021, the patient experienced angina, fever, chills, cough, sore throat, runny nose, nausea, diarrhea, headache, arm heavy, muscle aches and heaviness, and she just woke up feeling sick. The patient experienced multiple AEs after 1st dose of vaccine (received on 23Jan2021). The patient experienced angina later last week. Clinical course: The patient has misplaced card, states her second appointment for the second dose is this Saturday. Caller stated she started having these experiences the day after she was vaccinated with her first dose, received first dose of 23Jan2021. She had fevers, chills, cough- not an aggressive cough, a funny kind of sore throat- like something wrapped around her throat like the muscles of her throat, no congestion but does have a runny nose, states she has some nausea, no vomiting but feeling like she needed to vomit and diarrhea, and headache. The symptoms started about the third day after the vaccine, started with the fevers, stated the fevers may come like a hot flash, lasts seconds even, states you know it is a fever because your bones get hot. These symptom's did not attack her body at one time. Her whole arm stayed heavy, the whole arm not just the injection site, for almost 10 whole days. She previously had fibromyalgia and thought maybe that made the symptoms worse. She had muscle aches and feeling heavy. Her symptoms were spread out over time, no two were at the same time, sore throat was one of the last things. Diarrhea was ongoing, not a runny diarrhea but it was enough to empty stomach and was soft. She was a medic in the military, worked as a Nurse, clarifies she was an LPN and took all the underlying courses to be a PA. One of the issues she found, she thought it may be deadly, as a prior healthcare person and in tune to her body, the people who are in the nursing homes may not be mobile, states so one of the things she felt was just feeling really really sick, that she couldn't put a pin point on it, states she just woke up feeling sick, states she had the urge to get out of bed and got up and after she got up the feeling left her, states a person in the nursing home may just feel really bad and cannot get up, thinks a protocol should be that the people that are immobile should be required to move or if they can't get up they need to move their muscles, people with these symptoms need to get up and get moving. She also has history of angina and a stent, has not had angina in a while and had 3 days where she thought she may need to go talk to her doctor. It was on Wednesday, Thursday and Friday this week. States one of her friends, 92 years old, said she got high after the vaccine and didn't want to talk to anybody, states it was her first dose, she was kind of leery about the 2nd shot, feels like this was kind of aggressive. She had both doses and had no symptoms, but 92-year-old female had no symptoms right away, other than normal body aches and pains, but the next day was high as a kite. Her son has heart disease and she advised him not to take it right now. They were losing a lot of people to the vaccine in nursing homes, no further information provided. This could be affecting good hearts more than damaged hearts, read that this virus likes to work in parts of the body that are already damaged. The outcome of event diarrhea was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, a causal association between the reported angina and BNT162B2 cannot be completely excluded. Note however, that the patient has underlying angina with some stents that may also have contributed to the event. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
72 2021-02-23 fever, lethargy, headache, chills About 9:30 arm began to get sore(expected) about 11:00 started with a headache, then chills, fever, ... Read more
About 9:30 arm began to get sore(expected) about 11:00 started with a headache, then chills, fever, achy from head to toe but mostly back and sides, nauseous, lethargic and couldn't sleep
72 2021-02-23 chills Chills 24 hrs after vaccine. Sporadic during day for up to 48 hrs. Total body rash noticed 36 hrs ... Read more
Chills 24 hrs after vaccine. Sporadic during day for up to 48 hrs. Total body rash noticed 36 hrs after vaccine, no raised areas or itching.. No difficulty breathing. Cetirizine HCL 10mg no change in rash after 1 hr.
72 2021-02-23 headache Elevated high pressure, nauseas, dizziness and strong headaches. Couldn't sleep well.
72 2021-02-23 fatigue Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. F... Read more
Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. For two days
72 2021-02-23 chills, fatigue, fever My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged ly... Read more
My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged lymph nodes and the lymph nodes under my arm has been very, very sore. I've had fevers, chills and fatigue. My stomach has been upset since the vaccine and my appetite has been decreased.
72 2021-02-23 throat irritation, cough She arrives with medics after receiving Benadryl and an albuterol breathing treatment. This improve... Read more
She arrives with medics after receiving Benadryl and an albuterol breathing treatment. This improved her wheeze. Upon my evaluation she is stable but begins to cough. She has moderate posterior pharyngeal irritation as well. She has been monitored. Chest x-ray is reassuring. The present do not think labs are necessary. She is been advised to monitor her symptoms at home and return for any concerns. I recommended Benadryl as well as short course of prednisone. She has received prednisone here and advised her to take prednisone tomorrow and then discuss additional doses with her primary doctor control
72 2021-02-23 fever feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; he... Read more
feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; her eyes start feeling funny and burning when she has a fever; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of 2 reports. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at the right upper arm close to the shoulder on 02Feb2021 07:30 at single dose as she doesn't want to get COVID again or give COVID to anyone else. Medical history included metabolic syndrome from 1994 and ongoing, it all started when she was 46 and it runs in her family and it was a genetic thing; ongoing diabetes mellitus, was diagnosed when she was 65, so 7 years ago; she had COVID in Nov2020 but it was just a very mild case and she just had a cough; and cardio artery problems. She takes a lot of medications and she has metabolic syndrome which includes cardio artery problems and diabetes, but she has taken all of those medications for a long time. The patient says she was calling to report a couple little concerns she has. She received her shot on Tuesday, 02Feb2021 at about 7:30 in morning and her arm started at about 2 to 3 in the afternoon and she noticed it was getting sore, but it was no big deal, she did not think anything of it, and on the second day she thought that was it and she was over it on 03Feb2021. She states her husband also mentioned that he had soreness in his arm after his vaccination. She says at three in the afternoon on 03Feb2021, she started feeling weak and shaky, but she didn't think much of that. She says this began around 3 to 4 when yesterday afternoon, 03Feb2021, she had a fever. She says she took her temperature and it was 100.4 and that all kind of was gone by the evening but when she woke up this morning, she was weak and shaky again. Today she got up and was weak and shaky and it never left, she was still weak and shaky. The patient mentions that she was diabetic so she can get weak and shaky when she needs to eat something, but she had just eaten, and she ate yesterday so she doesn't think it was caused by that. The patient says she thinks we should know that she was diabetic. She says then she could tell that she had a fever, so she took her temperature and it was 100.4 which for her was high. She states she didn't even have a fever when she had COVID. The fever began yesterday afternoon (03Feb2021). She says her eyes start feeling funny and burning when she has a fever and they felt that way so that's why she took her temperature. This was the highest it has been in years. She says last night she took her temperature again and the fever had gone away in 30 to 40 minutes, so she thought it was over. She took her temperature again before she called this morning, 04Feb2021 and it was 99.2, which was still a little hot for her. She says for her that's a fever. She was 96 and 97 usually. The patient says she still feels like she has a little fever. She was not someone who usually has a fever and it can be just a little bit of a fever for instance like this morning when she was 99.2. Her eyes were still feeling funny and burning this morning and that was why she took her temperature this morning. The outcome of the event arm was a little sore was recovered on 03Feb2021; feeling weak and shaky was not recovered; fever and her eyes start feeling funny and burning when she has a fever was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162089 Same reporter/drug, similar event, different patient
72 2021-02-23 fatigue, chills pt states that the next day after her vax she had weakness, chills, fatigue and she still has these ... Read more
pt states that the next day after her vax she had weakness, chills, fatigue and she still has these symptoms. Pt states that the injection site hurt for just a few days. Pt contacted her PCP regarding her symptoms and was told not worry about them at this time but has an appt next week for an annual check up and will FU w/ her about this at that time.
72 2021-02-23 malaise, nasopharyngitis she just does not feel good; Feeling like she is getting a cold; This is a spontaneous report from a... Read more
she just does not feel good; Feeling like she is getting a cold; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: 30Apr2021), via an unspecified route of administration on the right arm, on 22Jan2021 at 0.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. Patient stated she was feeling like she was getting a cold. She clarified that she started feeling this way starting last night on 25Jan2021, and today on 26Jan2021, she just does not feel good. Outcome of the events was not recovered. The reporter considered the events non-serious.
72 2021-02-24 chills, fatigue, malaise, headache Fatigue, headache, Muscle/Joint Pain, Chills, Feeling unwell, dizziness
72 2021-02-24 body temperature increased, fever I was feeling chilly and I went to bed early and got under the covers. At 3 in the morning, I had a ... Read more
I was feeling chilly and I went to bed early and got under the covers. At 3 in the morning, I had a fever - 99. something and aches and pains. I took ibuprofen. I got up at 7:00 am and my temperature had gone up to 100 something. My body ached really bad. It ached all day long ( and fever continued) and it felt like I had a really bad flu. I called my doctor (telemed appt) and she thought it would be over by 24 hours. It did go away after 24 hours.
72 2021-02-24 headache Light headed and dizziness, left side headache tingling sensation down entire left arm to finger t... Read more
Light headed and dizziness, left side headache tingling sensation down entire left arm to finger tips, and up to chin neck and chest area for about 20 minutes
72 2021-02-24 chills, headache Mid afternoon on Wednesday, February 24, 2021, I developed a headache, severe chills, body aches, qu... Read more
Mid afternoon on Wednesday, February 24, 2021, I developed a headache, severe chills, body aches, queasiness, and I felt very tired. I am currently running a 101 temperature and feel Ike terrible
72 2021-02-24 chills, cough Received 2nd vaccine on 2/20/21. Started having some tightness in her throat and tingling on her ton... Read more
Received 2nd vaccine on 2/20/21. Started having some tightness in her throat and tingling on her tongue the next day. Two days later started having dizziness, and itchy rash and SOB, chills, and nonproductive cough. Went to ER on 2/24/21
72 2021-02-25 fatigue, fever, headache Fever 5am through midnight Headache Nausea am Tired
72 2021-02-25 headache, chills, fatigue None for first injection. Second injection started with extreme chills, moved to headache, muscle ac... Read more
None for first injection. Second injection started with extreme chills, moved to headache, muscle ache, weakness. Lasted 24 hours, mitigated with Tylenol. 10 days later, still suffering intermittent fatigue, weakness, inflamed lymph node near left breast, diarrhea and muscle ache.
72 2021-02-25 headache, fever, head discomfort pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms... Read more
pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms, hands and knees, a splitting headache, also had pain in her ears, face, and upper back. Next day the pain was worse. Pt contacted her PCP and was told to report to VAERS. She still has pressure in her head, eye, ear ache and cant do regular every day activities.
72 2021-02-26 chills Developed nausea and vomiting after her COVID vaccine earlier today. Associated with chills and trem... Read more
Developed nausea and vomiting after her COVID vaccine earlier today. Associated with chills and tremors. These improved 45 minutes ago. Poor PO intake. No abdominal pain. COVID, flu negative. Mild systemic vaccine reaction. Zofran given and rx. Advised patient to speak with her PCP before considering second COVID vaccine.
72 2021-02-26 fever, fatigue Had low grade fever of 99 degrees. Extreme fatigue. Shot site is bright red, swollen. Area around... Read more
Had low grade fever of 99 degrees. Extreme fatigue. Shot site is bright red, swollen. Area around site is swollen, red, and hard to the touch. Swelling, redness, and hard to the touch continues. Hurts to touch or bump entire area.
72 2021-02-26 chills, headache On Feb 26th - approximately 45 minutes after vaccination and departing site, symptoms began. Swelli... Read more
On Feb 26th - approximately 45 minutes after vaccination and departing site, symptoms began. Swelling tongue and throat. Wheezing and difficulty swallowing. Proceeded to ER and taken in at 2pm. Treated at ER with IV of Benadryl, Famotidine, MethlyPredeniSolone, Medrol with little effect. Then did Epipen at 2:40pm. Observed and discharged from ER at 4:50pm . On Feb 27th - skin hives, headache, nausea, chills and overall body pain. Taking Benadryl. Have Rx with 2 EPIPEN kit.
72 2021-02-26 fatigue, headache Tiredness, headache, nausea
72 2021-02-28 chills, fever, sweating I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in gener... Read more
I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in general I feel like I have been poisoned.
72 2021-02-28 fatigue, chills, malaise, headache One week after shot, on 2-27 21, I awoke with splitting headache, muscle pain in my neck, nausea, a ... Read more
One week after shot, on 2-27 21, I awoke with splitting headache, muscle pain in my neck, nausea, a few chills (they did not last long), felt horrible for about 5 hours. I threw up midway, and then just slept. Felt a little better around 2:00 pm, took Tylenol at 4:00pm and that helped a lot. Got out of bed at 5:00 pm. Was able to eat a little dinner at 6:00 pm. Went back to bed around 9:00. Felt better in Am -Sunday, Feb 28; not 100% though. Tired. Long nap. Better today, Mar. 1. -- just a little off - woozy.
72 2021-02-28 throat pain, cough, runny nose Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous re... Read more
Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received the second of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9267, Expiration Date May2021, via an unspecified route of administration on 08Feb2021 (at the age of 72 years old) as SINGLE DOSE in the left arm for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Historical information included BNT162B2 dose 1 for COVID-19 vaccination.The patient developed the sore throat on 09Feb2021, Cough; bad cough on 10Feb2021, constant running nose on 11Feb2021. On 11Feb2021, the patient passed out in the bathroom floor, had an ambulance here. Patient still coughing a little, not as badly. The patient experienced diarrhea in Feb2021. Treatment for all events included cetirizine (ZYRTEC), Triamcinolone (NASACORT), pseudoephedrine (SUDAFED), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL). Outcome of the events Passed out, Sore throat, Constant running nose, Diarrhea was unknown. Outcome of the events Cough; bad cough was not recovered
72 2021-02-28 sleepiness, fatigue Sleepy and weakness. Drunk like sx at 1900 hr. Currently very tired. Steady gait.
72 2021-02-28 headache, malaise Trouble breathing; nausea; severe headache/excruciating headache; Feeling generally unwell to the po... Read more
Trouble breathing; nausea; severe headache/excruciating headache; Feeling generally unwell to the point I almost went to the emergency room/terribly unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-preganant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EN5318, via an unspecified route of administration on 02Feb2021 15:45 (at the age of 72 years old) for COVID-19 vaccination, Unspecified other vaccine (Pfizer) on 02Feb2021, dose number in the left arm for an unspecified indication.Medical history included asthma from an unknown date and unknown if ongoing (asthma under control), pancreatitis chronic from an unknown date and unknown if ongoing (Occasional chronic pancreatitis), Blood pressure from an unknown date and unknown if ongoing, drug allergies from an unknown date and unknown if ongoing. Concomitant medication included Blood pressure medication. The patient previously took morphine and experienced allergies morphine and sulfa and experienced allergies sulfa. The patient received the vaccination at the hospital. On 02Feb2021, the patient felt as if she was having a heart attack. On 02Feb2021, the patient had trouble breathing, nausea, and severe headache. On 02Feb2021, the patient was felling generally unwell to the point she almost went to the emergency room. The excruciating headache and terribly unwell feeling has lasted well over 10 days. No treatment was received for the events. Outcome of the events was recovering. The patient did not have covid prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.
72 2021-02-28 cough, chills, headache, fatigue, fever fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain o... Read more
fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain onset 12 hours after receiving the vaccine ongoing at this point
72 2021-03-01 malaise, headache, chills, fever Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating m... Read more
Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating much; Achy; This 72- year-old female patient contactable consumer (reported for herself) received the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EL9265; expiration not provided), via an unspecified route of administration, on 28Jan2021 at 09:15 AM (at the age of 72-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital. Medical history included: COVID in Mar2020 and was hospitalized for 10 days, hypertension, thyroid disorder, and flu shot. Concomitant medication included: Hydrochlorothiazide 12.5 mg, once a day for blood pressure and medication for thyroid reported as: "NP" 0.5gms. On 28Jan2021 later on after vaccine, she reported 9:15 pm that she did not feel good. She had chills, fever, headache, did not feel like eating much, was achy, and not feeling very energetic. During the night temperature was 101.4. At 8 in the morning, I started taking 2 Tylenol, 500 mg and it went lower but then it would come back up, so I take more. So, it never went over 101.8. now here we are on the Saturday morning and I am not feeling very energetic and I still have just a 99 temperature. Treatment included: Tylenol. The clinical outcome of the events I did not feel good, chills, fever, headache, did not feel like eating much, Not feeling very energetic, and Achy were unknown. No follow-up attempts are possible. No further information is expected.
72 2021-03-01 sleepiness SOB, weakness, bilateral trembling, feeling sleepy, evaluated by EMS-cleared
72 2021-03-01 sleepiness Sleepy, drowsy, evaluated by EMS-cleared
72 2021-03-02 chills Chills beginning the night of the injection and continuing to today.
72 2021-03-02 fever, headache Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash ... Read more
Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared day after injection as well as burning. Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
72 2021-03-02 chills Pfizer Covid-19 Vaccine second dose on 02/28/2021 at 1:00 P.M. Very chilly all day next day on 03/... Read more
Pfizer Covid-19 Vaccine second dose on 02/28/2021 at 1:00 P.M. Very chilly all day next day on 03/01/2021. Redness and pain on the arm at the vaccine site on 03/03/2021 at 9:00 A.M.
72 2021-03-02 chills, headache hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could ... Read more
hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; tense muscle aches; Chills; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 72-years, via an unspecified route of administration in left arm at 11:00 AM on 16Feb2021 at single dose for COVID-19 immunisation, in hospital. Medical history included pituitary microadenoma from 1969 (52 years) and in good health other than the fibromyalgia; allergies to latex. Patient was not pregnant, was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desipramine; duloxetine hydrochloride (CYMBALTA); ergocalciferol (VIT D); zinc. The patient previously received first single dose of BNT162B2 (lot number: EK9231) at the age of 72-years via an unspecified route of administration in left arm at 04:00 PM on 25Jan2021 for COVID-19 immunisation. Patient reported that she had been diagnosed with fibromyalgia and saw a rheumatologist that specializes in treating fibromyalgia. At 01:00 AM on 17Feb2021, fourteen hours later, she awoke to not being able to turn over in bed. Her hands, feet, toes and entire body, felt almost paralyzed. She could not bend her fingers or toes. Her muscles throughout her body remained stiff and tight for the next 16 hours. Chills, headache but no fever. Patient took paracetamol (TYLENOL) every four hours, during this time. It did not help with the tense muscle aches. Later on 17Feb2021 (that same day), approximately 19:00 (7:00 PM), her muscles started to relax. Patient was writing this the day after and she felt fine. She could hardly wait for the booster shot. Outcome of the events was recovered/resolved in Feb2021. Since the vaccination, the patient has not been tested for COVID-19.
72 2021-03-03 fever, chills, headache, fatigue 2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, ... Read more
2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, with fever & brain fog, & felt very weak, & I had a swollen & sore lymph node under my arm. On day 6 my upper are (& underneath) turned red & swollen. I also had been suffering random itching. On day 8 I went ER, & was given steroid cream. That night most of my back turned red. I put the cream on & it was gone next day, but my arm stayed red & itching. All this has made me weaker, & My stomach hasn?t felt good.
72 2021-03-03 fever, chills, headache Chills,fever,almost passed out,headache,sore arm
72 2021-03-03 chills, fever Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report... Read more
Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the left arm on 25Jan2021 (13:45) at a single dose for COVID-19 immunization at the university clinic (not a military facility). Medical history allergy to penicillin; allergy to bees; allergy to environmental grass and ragweed; and was in muscle relaxant therapy. Concomitant medications included cannabidiol (CBD OIL) as muscle relaxer; and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). The patient previously took SHINGRIX on 18Oct2019 (when the patient was 71 years old) for shingles vaccine, and had subacute thyroiditis, enlarged thyroid and glands, rash from wrist to arm and shoulder, swollen and sore arm, and swollen neck glands and thyroid around left side. The patient previously took codeine, and had allergy. On 25Jan2021 (20:00), the patient had sore arm. The sore arm improved the next day. On 30Jan2021 (between 18:00 and 19:00), the patient was "sort of" feeling achy. On 30Jan2021 (23:00), the patient had fever of 100.4 (unit was not provided). The patient took paracetamol (TYLENOL) as treatment for the fever, and started getting better. The patient got tested as a precaution, and was negative for COVID-19 test on 31Jan2021. On 31Jan2021 (between 08:00 and 09:00), the patient had stomach issues. On 31Jan2021 (13:00), the patient had chills. The outcome of the events, 'sore arm', 'achy', 'fever', 'stomach issues' and 'chills', was recovering. The patient was due to the second dose of vaccination on 15Feb2021, and wanted to know if it would be okay for her to get it.
72 2021-03-03 headache Numbness and slight swelling on entire left side of face within half hour following shot, accompanie... Read more
Numbness and slight swelling on entire left side of face within half hour following shot, accompanied by severe stiff neck (left side). Headache and slight transient facial rash with skin discoloration under eyes about two hours later. Mostly subsided by 10:30 PM- about eight hours later, although some numbness remained l through the night. Symptoms were mostly gone the next morning, replaced by arm soreness and bruising at the injection site. Black and blue remains (3 days later).
72 2021-03-03 sweating Pt received her first dose Pfizer Covid 19 vaccine and was currently being monitored in the observat... Read more
Pt received her first dose Pfizer Covid 19 vaccine and was currently being monitored in the observation area for 30 minutes when she developed vasovagal symptoms- diaphoresis, near syncopal episode and hypotension. EMS and nurses responded with the event. initial BP = 90/40. Pt was transferred immediately to the treatment room, was placed on supine position and was further monitored. Pt relates she has these symptoms every time she has her blood drawn. Repeat BP=106/56 after 5 mins. Pt became better after 15 mins, BP=127/68, pulse ox=98 RA, pulse=70.
72 2021-03-03 fatigue aches; itching; kind of tired; This is a spontaneous report from a contactable consumer (patient). ... Read more
aches; itching; kind of tired; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262, expiry date unknown) in the doctor's office, via an unspecified route of administration on 27Jan2021 at a single dose on the right arm as she was over 65, for COVID-19 immunization. Medical history included ongoing diabetes mellitus a long time ago since she was in her 60's, ongoing blood pressure, ongoing high cholesterol and cyst. Concomitant medication included ongoing losartan (manufacturer unknown) for blood pressure, ongoing pravastatin (manufacturer unknown) for high cholesterol, metformin (manufacturer unknown) for diabetes mellitus from an unspecified date to an unspecified date and ongoing sitagliptin (JANUVIA) for diabetes mellitus. The patient was also prescribed an unspecified antibiotic for a cyst which was taken 2 weeks before the vaccination. The patient did not have prior vaccinations within 4 weeks of the COVID vaccine. The patient experienced itching on 27Jan2021, the same day as the Covid 19 shot later in the day, after she got home. She didn't pay attention to it. The next evening she called her doctor and told him about it and he said it was one of the side effects of the Covid 19 shot and prescribed Benadryl. She started the Benadryl that same night, 28Jan2021. She should not have waited, she should have called the doctor the same day. She called the pharmacy and got the prescription, it's not that far for her. The patient stated that the the itching lasted a couple of days, it is gone, as of an unspecified date. She took Benadryl for the itching, it is the best thing for her. In all, she thinks she went through 2 to 3 days of the whole situation. The patient also stated that she took Tylenol for the aches and that got better. She had aches but the aches from the Covid 19 shot started on 28Jan2021. On the day of the report, she was a lot better. The aches went away but does not recall what day they went away. She feels much better that day. The aches were not severe. She added that the aches and itching lasted for 2-3 days and are totally improved, that they stopped on an unspecified date. State she was able to go outside that day. She added that she was kind of tired. She had to lay down one day because the itching and aches were bad. The outcome of the event kind of tired was recovering while the outcome of the other events was recovered on an unspecified date in 2021.
72 2021-03-03 throat irritation left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear wh... Read more
left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear where you cannot scratch; severe tightness in her left eye that felt like it was going to swell up; hot skin for several hours; hot flashes; She has itching in ears and throat; Onset of burning and itching; Skin had feeling of about to break out in hives/full blown body hives all over; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3249), intramuscular on the right arm, at the age of 72 years, on 13Jan2021 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient would like to know if the vaccine was derived from or does it have any products from Acacia. One of the reason's she was asking was because she knows it has Polyethylene Glycol in it. Her resources are limited. She was a retired healthcare provider and she taught graduate level nursing and has background in epidemiology and public health. The Polyethylene Glycol was in the vaccine, according to the prescribing information. Some forms of Polyethylene Glycol in some type of way are derived from gum acacia and she does not know if this is the case for the COVID vaccine. She did have 1st dose and waited 15 minutes. When her left eye felt tight and felt itchy, she took 2 Benadryl and then waited in car a little longer. She felt like she was going to go into what she has had in past 3-4 times relating to fish. She has had full blown facial swelling, intense itching in inner ear where you cannot scratch. Those times, if she had chopsticks, she would want to scratch inside her ear. She never had that with the COVID vaccine. They told her when she got the vaccine that if this develops further, she should go to her doctor or ER, but should not come back there. She did not want to go to the ER and sit there for 12 hours waiting to see if she was going to have a worse reaction, so she went home, took 2 more Benadryl, and went to bed. Eight hours later, she was fine and did not have hives. She then stated she completed report with Pfizer online and did not have a reference number for previous report. For those time when she had these episodes with the fish, she had extreme itching and hives. The worst allergy she had, her fingers looked like they were webbed. She was treated with Adrenaline, Cortisone and Benadryl by injection and that would usually stop the reaction, but it usually takes 3-4 days for the swelling to go down. In later years, if there is a piece of fish mixed in with fried shrimp and she inadvertently eats it, she knows it immediately. She will take Benadryl immediately. She will have facial swelling and swelling around her eyes. The Benadryl will contain it. She will be disfigured for 2 weeks, with bags of fluid in her cheeks. She is going for her second shot tomorrow. She can self treat with Benadryl. In 1994, she had a very positive wheels from an intradermal scratch testing for Acacia and codfish. The patient had an onset of burning and itching, periorbital. She took 2 25 mg Benadryl tablets. She has itching in ears and throat. After my 15 minutes waiting, she left. She had various hot spots of burning skin, legs and arms. Left eye felt like past episodes of itching, about to swell. Her skin had feeling of about to break out in hives. Facility said to go to provider or ER if got worse. She chose not to go to ER, and wait and be miserable for hours on end, while waiting for full blown body hives all over. She took two more 25 mg Benadryl and went to bed. She had intermittent burning skin, various areas, for several hours. About 8 hours later, was resolved. The patient was about to receive 2nd dose of the Covid vaccine. After the 1st dose she experienced an itchy feeling in throat, rotating heat in arms and legs, slight bag fluid under left eye and it felt to her like she was going to have an allergic reaction but did not. She took some Benadryl and after 8 hours she was fine. The patient stated after the first dose of the vaccine she had itching, severe tightness in her left eye that felt like it was going to swell up, and hot skin for several hours. She took two Benadryl while she was still in the waiting period and perhaps that blunted the reaction. She had hot flashes on the drive home. She took two more Benadryl at her daughter house (100mg total after taking 4 that day). She didn't feel good and felt she was on the verge of getting hives. She had episodes of hot skin and itching and after 8 hours it was over and done with and she was fine. She stated she is nervous about the second dose but stated they have what they need if she has an immediate reaction and it is worth the risk of getting vaccinated. Therapeutic measures were taken as a result of left eye felt tight and felt itchy/severe tightness in her left eye (eye pruritus), intense itching in inner ear where you cannot scratch (ear pruritus), onset of burning and itching (skin burning sensation), skin had feeling of about to break out in hives/full blown body hives all over (urticaria). The outcome of the event onset of burning and itching and skin had feeling of about to break out in hives/full blown body hives all over was recovered on an unspecified date while other events were unknown.
72 2021-03-03 chills severe vertigo, chills, nausea, vomiting
72 2021-03-03 headache stomach cramps; massive diarrhea; nausea; headache; This is a spontaneous report from a contactable ... Read more
stomach cramps; massive diarrhea; nausea; headache; This is a spontaneous report from a contactable consumer (patient). This 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot EK9231) via an unspecified route of administration in the left arm on 22Jan2021 at 17:15 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included anal cancer from 2009 and unknown if ongoing; and cancer Non-Hodgkin's lymph from 1993 and unknown if ongoing. The patient had no allergies to medications, foods or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included sertraline 100 mg from an unknown date for an unknown indication; rosuvastatin 5 mg from an unknown date for an unknown indication and cetirizine hydrochloride (ZYRTEK) from an unknown date for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported on the fifth day (27Jan2021) she had stomach cramps, massive diarrhea, nausea and headache and had to lay down; lasting from about 09:00 to 18:00. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of stomach cramps, massive diarrhea, nausea and headache were recovered on 27Jan2021 at 18:00. It was also reported the patient was not tested for COVID-19 since vaccination.
72 2021-03-04 headache, fever Body aches, Headache, Fever of 100.4. Took 2 Tylenol. Still Fever of 99.8 6 hours later. Took 2 m... Read more
Body aches, Headache, Fever of 100.4. Took 2 Tylenol. Still Fever of 99.8 6 hours later. Took 2 more Tylenol.
72 2021-03-04 headache, chills, fatigue, fever Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until ... Read more
Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a bit feverish but getting better. A more severe reaction than from first shot on 2/8/2021 with similar side effects that lasted about 3 days. Fatigue did not go away.
72 2021-03-04 fever, headache, chills Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until ... Read more
Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a little better.
72 2021-03-04 malaise, headache, fatigue Headache; profound fatigue/tired; not feeling well; sick; This is a spontaneous report from a contac... Read more
Headache; profound fatigue/tired; not feeling well; sick; This is a spontaneous report from a contactable consumer. A 72-Year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, lot number unknown, expiration date unknown), via intramuscular on the left upper arm, on 21Jan2021 at 16:30 at the age of 72 years old at a single dose for COVID-19 immunisation at senior residence. The patient medical history was none. Concomitant medications were not reported. The patient previously took Shingrix for shingles vaccine (immunisation) and both times she took it she was in bed for 3 days and then she was fine. Patient was calling about the Pfizer BioNtech covid vaccine. Since she had the vaccine and this is the 8th day since she had it. On 21Jan2021, patient had a headache and profound fatigue, she was not feeling well since she got the vaccine. She was still sick on an unspecified date in 2021. Her headache started about 30 minute s after getting the vaccine. That same night she felt really tired and when she woke up she was really fatigued. The patient occasionally takes Advil as treatment. The patient did not visit emergency room and physician office. No additional vaccines administered on same date of the Pfizer suspect. The patient was not recovered from the event sick, while patient was recovering from all other events. Information on lot/batch number has been requested.
72 2021-03-04 fatigue, headache Headache; tired; This is a spontaneous report from a contactable consumer. A non-pregnant 72-year-o... Read more
Headache; tired; This is a spontaneous report from a contactable consumer. A non-pregnant 72-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EL9261), via an unspecified route of administration in the left arm on 01Feb2021 at 14:00 at 72-years-old at a single dose for covid-19 immunization; administered in a hospital. . The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's medical history was reported as none. Concomitant medications included elderberry [sambucus nigra] (MANUFACTURER UNKNOWN), krill oil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D); all taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of vaccination. On 02Feb2021 (also reported as 01Feb2021 at 16:00), the patient experienced headache (non-serious) and tired (non-serious). There was no treatment received for the adverse events. The clinical outcome of the events was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.
72 2021-03-04 malaise, chills, fatigue, headache Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and... Read more
Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and then blacked out woke up laying on floor, couldn't move arms or legs, not sure if hit head, laid on floor close to 1 hour, difficulty getting back into bed, extreme nausea, dry heaves, weak, headache, dizzy, chills, dizzy x 1 week, dizzy 3/3/21, got into bed 6:30 PM, face flushed and reddened, called daughter who is nurse, daughter checked temperature and blood pressure, no fever, B/P 156/102 (normally 120/82), B/P came down to when retaken to 140/90), was "upset" at time of first B/P reading, causing elevation. Continues to have weakness and fatigue, headache comes and goes.
72 2021-03-04 fever, headache Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hou... Read more
Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hours. After 4 hours weak for several hours.
72 2021-03-07 malaise, fatigue, headache Headache; Tired; feeling unwell; This is a spontaneous report from a contactable consumer (Patient).... Read more
Headache; Tired; feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 72-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 02Feb2021 at the age of 72 years old at a single dose for COVID-19 immunisation. The patient medical history was none. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient previously took keflex [cefalexin monohydrate] and experienced allergy, first dose of BNT162B2 (lot number: EI8982) on arm left on 12Jan2021 04:00 PM at the age of 72 years old for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. It was reported that on 02Feb2021 20:00 PM, Headache started about 5-7 hours after injection. Continued for another 24 hours. Tired and feeling unwell also for the 30-36 hours after injection. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021.
72 2021-03-07 fever Patient is a 72-year-old female presenting with fever and altered mental status. History is obtaine... Read more
Patient is a 72-year-old female presenting with fever and altered mental status. History is obtained for the patient and her husband. She got her second dose of Pfizer vaccine for Covid on 3/6/21. On 3/7/21, she woke with fever and urinary symptoms. She have an episode of incontinence and urinary frequency and urgency today. She was too weak to get up out of the recliner at home. She did have a fever this morning, which resolved with Tylenol. She also has been confused much lower mentally than normal. She is on 4L chronically for COPD, DM, HTN, HLP, CAD, previous DVT. She has had sepsis previously. She was admitted to the hospital, and received one dose of IV Rocephin, IV fluids, and tylenol.
72 2021-03-07 headache Tested positive for Covid; Really bad headache; Shooting pain; This is a spontaneous report from a n... Read more
Tested positive for Covid; Really bad headache; Shooting pain; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 26Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had really bad headache with shooting pain exactly one week after COVID vaccine (noted on 02Feb2021). The patient also tested positive for COVID one week later on 03Feb2021. Outcome of the events were unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
72 2021-03-08 chills, headache Chills; Headache; Muscle aches; This is a spontaneous report from a contactable pharmacist. A 72-yea... Read more
Chills; Headache; Muscle aches; This is a spontaneous report from a contactable pharmacist. A 72-year-old non-pregnant female patient (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 05Feb2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, fibromyalgia, sleep apnea. The patient was not diagnosed with COVID prior to the vaccination. The patient had no known allergies. Concomitant medications included hydrochlorothiazide/valsartan, celecoxib, duloxetine. There were no other vaccines administered within 4 weeks of the vaccination. On 06Feb2021 at 06:00, the morning after the vaccination, the patient experienced chills, headache, and muscle aches. The patient was treated for the events with 600 mg of ibuprofen and the symptoms subsided. Since the vaccination, the patient was not tested for COVID. The clinical outcome of chills, headache, and muscle aches was resolving. Information on the lot/batch number has been requested.
72 2021-03-10 nasopharyngitis, throat irritation, nasal congestion Head cold; Diarrhea; developed a kind of allergies like a scratchy throat; Congested; This is a spon... Read more
Head cold; Diarrhea; developed a kind of allergies like a scratchy throat; Congested; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262), via an unspecified route of administration on 25Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 immunization. The patient's medical history included 'thyroid' from an unspecified date and unknown if ongoing. Concomitant medications were not reported. On an unknown date, reported as all of the sudden, the patient experienced a kind of allergy like a scratchy throat and then I was congested, a bad head cold (started last week) and from last night I started to have diarrhea. The clinical outcome of head cold, diarrhea, scratchy throat and congested was unknown.
72 2021-03-10 headache Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; no... Read more
Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; non-amblitory, could not support weight, major balance issues. Televisit 1/26/21=earache. Blacked out cold 5 min, non responsice 30 min 2 am 1/26/21; woke with Bell's Palsey; Ddumb televisit 1/28/21=BP. Urgent Care visit-EKG (normal), bloodwork, urine lab work. 2/1/21 Saw NEURO = MRI brain w/contrast to rule out cancer (2/4/21; Two weeks of solid hallucinations 24/7. Horrendous balance issues-almost non-amblitory from onset 1/26/21 to present. Lost 9 pounds in 2 weeks.(I was 104 now 95 pounds). I was walking 5 mi a day, walked 1/24/21, healthy. Devastating pain to left side of head/face, esp ear. PAIN
72 2021-03-14 headache, nasopharyngitis, chills severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hur... Read more
severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hurt 48 hours; severe whole body muscle pain even my fingers hurt 48 hours; drooling woke me up soaked the pillows; headache worse in my life 48 hours; dropping things hands wouldn't work; vomiting; severe diarrhea still problematic; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Still can't function normally 5 days now after 2nd shot; Still stuck in the house to weak to leave; Cognitive dysfunction; could not drive; trouble speaking; pins and needles both arms and legs; ataxia; received second dose of bnt162b2 on 19Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 72-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 19Feb2021 01:15 pm on left arm at single dose for covid-19 immunisation. Medical history included Known allergies: iodine dye X-rays from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took first dose of bnt162b2 (COVID 19, brand: Pfizer) on 22Jan2021 at arm at single dose for covid-19 immunization. The patient experienced cognitive dysfunction (cognitive disorder) (medically significant) on 19Feb2021 18:00 with outcome of not recovered, could not drive on 19Feb2021 18:00 with outcome of not recovered, trouble speaking on 19Feb2021 18:00 with outcome of not recovered, pins and needles both arms and legs on 19Feb2021 18:00 with outcome of not recovered, ataxia on 19Feb2021 18:00 with outcome of not recovered, severe brain fog still 5 days later dysfunctional on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, drooling woke me up soaked the pillows on an unspecified date with outcome of not recovered, headache worse in my life 48 hours on an unspecified date with outcome of not recovered, dropping things hands wouldn't work on an unspecified date with outcome of not recovered, vomiting on an unspecified date with outcome of not recovered, severe diarrhea still problematic on an unspecified date with outcome of not recovered, chills/cold shaking so hard teeth chattered on an unspecified date with outcome of not recovered, still can't function normally 5 days now after 2nd shot on an unspecified date with outcome of not recovered , still stuck in the house to weak to leave on an unspecified date with outcome of not recovered. No treatment received. She is not pregnant. Facility type vaccine was hospital. No other vaccine in four weeks. The patient reported that "Cognitive dysfunction, could not drive, trouble speaking, pins and needles both arms and legs, ataxia, stumbling. 72 hours of ataxia severe Brain fog still 5 days later dysfunctional severe whole body muscle pain even my fingers hurt 48 hours drooling woke me up soaked the pillows , headache worse in my life 48 hours dropping things hands wouldn't work vomiting and severe diarrhea still problematic Chills/cold shaking so hard teeth chattered Still can't function normally 5 days now after 2nd shot Still stuck in the house to weak to leave , still ataxic." No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch number is requested.
72 2021-03-15 head discomfort, headache I am reporting the below as everything written has NEVER happened to me before in my 72 years of liv... Read more
I am reporting the below as everything written has NEVER happened to me before in my 72 years of living. This has all taken place since I have had the Vaccine Injection on Wednesday, February 24th. I am attributing all of this as a possible reaction to the vaccine or maybe coincidence. I wanted to report what has taken place so you all can assess if this is a possible adverse reaction, a direct effect from the vaccine or just coincidence. Please let me know if anything like this has been reported and what your thoughts about the matter. Wednesday, February 24th 11:15am Pfizer Vaccine right arm ?about an hour later discomfort on shot side that went from the shoulder up the right side of the neck. Was gone by next day. Thursday, February 25th Day seemed to be normal. When I went to bed that evening a pressure and pounding on the left top side of the head, on the part line. Lasted 5-6 hours and then went away for that episode. Friday, February 26th Day started off OK, walked 2 miles and then ran some errands. *3:00pm I bent down to pick up something and when I came up I had extreme light headedness like I have never had before. I was able to get myself collected and then continued to get ready to go out. *6:00pm I just sat in a chair in the restaurant and BAM the room started spinning at about 500 miles (that is the speed that it felt like) an hour. My arms were flailing as I was trying to grab something to old onto. Just when I was about to fall off of the chair my husband walked up and grabbed me as he could see that something was going on and he said that I was white as a sheet. Once I got somewhat collected, I knew immediately that I had to throw up. My husband took me to the restroom. I had severe dry heaves that just would not stop. I wasn?t breathing properly so my hands and feet were numb, tingly and very white in color. Then I had to have a bowel movement. We phoned for the ambulance to take me to the hospital jus to make sure that I did not have a stroke, or it was my heart, or a vessel had burst in the head. The Paramedic tested me for a stroke and I passed the test. *8:00pm or so I had another episode with room going around at top speed and I started having dry heaves. Nurse gave me medicine in the IV for nausea. My Doctor said that everything was Benign. He said that the CT patient scan was negative and all other tests were OK. Saturday, February 27th I was released from the hospital and went home. I did very little that day. I slept that night from 10:00pm until 10:00am the next day. Sunday, February 28th I was lightheaded, had a headache, and ears ringing all day. I just did not feel myself at all. Tuesday, March 9th Around noon I had a severe lightheadedness/spinning episode, eyes felt like they were spinning. Laid down for about 2 hours and when I got up I was able to function and the spinning had gotten better. Headache all night long, ears ringing, feeling of lightheadedness. Wednesday, March 10th Not quite as dizzy, headache all day, back of neck and left side of head sore to touch. Pounding on left top side of head ? along the part line, where I had the same discomfort the 2nd day after the vaccine. Thursday, March 11th Having discomfort on left side of head. To the right of the left ear, going down to the neck. I can touch those areas and add to the discomfort. Friday, March 12th On Monday, March 7th I noticed a red spot on the right side behind where I was given the injection. I tried to treat it myself but my remedies were not helping. Contacted my Dermatologist on Thursday, March 11th. She saw me today, Friday, March 12th. She is not sure if it is a possible aftermath of the vaccine or something else. Had some bloodwork run to rule how Shingles. Prescribed some medication for Shingles to take until Monday when the bloodwork report is due for review. Blood work was negative for Shingles. Ever since the episode on February 26th I have NOT felt myself at all. Lightheaded, nausea, headache, pressure in head and feels heavy, not steady on my feet, discomfort in back of head near neckline, on/off discomfort in the top of the head with a pounding force. BLOOD PRESSURE IS NOW HIGHER THAN NORMAL ESPECIALLY WITH BOTTOM NUMBER BEING HIGH. I have never had a Blood Pressure problem, although as I have aged the top number has elevated but not enough to take medicine. However, the lower number is now elevated (high 80-?s, low mid range 90?s) and Cardiologist is going to make a decision on whether I should start on a low dose medicine. I am to take my 2nd Pfizer shot tomorrow ? Wednesday, March 17th at 11:00am. Thank You for reviewing the above writings. I look forward to the conclusion VAERS makes on my situation.
72 2021-03-18 fatigue, cough 2/22/21 Patient presented to ED w/ cough, SOB and fatigue. Initial RA pulse ox 86%. She was admitted... Read more
2/22/21 Patient presented to ED w/ cough, SOB and fatigue. Initial RA pulse ox 86%. She was admitted and was found to have COVID and was admitted. She was treated with med nebs and prednisone. She was maintained on O2 per nasal canula until 3/2/21. She reportedly had been having symptoms for 2 wees prior to admission so Remdesivir was deferred. Hospital course prolonged by very slow progress with rehab and she was discharged to rehab on 3/3.
72 2021-03-18 throat pain, fever, fatigue Fever of 3 degrees; extreme fatigue; nausea; dizziness; loss of appetite; loss of smell/taste; loss ... Read more
Fever of 3 degrees; extreme fatigue; nausea; dizziness; loss of appetite; loss of smell/taste; loss of smell/taste; sore throat; This is a spontaneous report from a contactable consumer. A 72-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 06Feb2021 (Batch/Lot number was not reported) at 72-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did have COVID prior to the vaccination. Medical history included penicillin allergy, Brazil nuts allergy, COVID-19 (recovered from COVID 11 days prior); all from an unknown date and unknown if ongoing. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; citalopram (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; famotidine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. On 07Feb2021 at 04:00, the patient experienced fever of 3 degrees (non-serious), extreme fatigue (non-serious), nausea (non-serious), dizziness (non-serious), loss of appetite (non-serious), loss of smell/taste (non-serious), sore throat (non-serious); which the patient described as "like a mini COVID storm." There was no treatment received due to the events. The patient underwent lab tests and procedures which included body temperature: 3 degrees on 07Feb2021. The clinical outcome of the events was recovered in Feb2021. The patient was not tested for COVID post vaccination. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
72 2021-03-18 headache, chills, malaise, cough RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tastel... Read more
RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tasteless/no taste; fibro; no taste/food was tasteless; She did not feel very well; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for her husband and herself. This is the first of two reports for herself. Only this case is serious. A 72-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot # EN6201, via an unspecified route of administration on 10Feb2021 17:15 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified products in two weeks. There was no other vaccine in four weeks.The patient experienced coughing, weak, no taste, chilling, diarrhea, no energy, headache all on 11Feb2021. She did not feel very well on the day she took her shot on 10Feb2021 but did not have a fever. She was not hungry but food was tasteless.It was also reported that "she had RA OA and fibro. and take thyroid medicine besides medicine for the others. Adverse event start date: 11Feb2021". No treatment was received for all events and events outcome was not resolved.The patient did not have COVID prior vaccination and no COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207100 same reporter/product, similar events, different patient
72 2021-03-22 headache Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose star... Read more
Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose started and continues until now. It decreased after dermatologist perscribed medication. On 3/13 went to hospital with severe chest pain. They determined it was muscular-sceletal. While in the hospital and to this day has burning in bottoms of feet. Has weakness and numbness in both legs and feet. The weakness decreases ability for activity- very uncomforatable and making her unsteady when up. She also has some weakness in her arms.
72 2021-03-23 nasal congestion my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started ... Read more
my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started feeling stuffy; felt flushed; my face was red; what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain; what feels like my heart quivering for several seconds; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at left arm on 08Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included gastroesophageal reflux disease, osteoarthritis, nodules on thyroids and allergy to Aspartsme. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40). the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took Sulfanomide (Sulfa drugs) and had allergy (swelling), codeine and had allergy (nausea). The symptom that has made patient concerned enough to report the possibility of a side effect is: she had her shot this morning and between about 8:55 and 9:15 this evening she had 9 or 10 episodes of what feels like her heart quivering for several seconds followed 3 or 4 times by very slight pain, just below her right breast, she has never experienced such a thing before. (she took baby aspirin around 9:20 in case she was having some kind of heart thing). It's 9:45 pm, and the quivering episodes haven't happened for the last 30 minutes, so maybe they're all cleared up. Earlier, within 30 min of getting the vaccine, her ears started feeling like they were stopped up and her nose started feeling stuffy. Then as she was driving home she felt flushed and looked in the mirror and her face was red, she took one Sudafed in case it was allergies, and those symptoms improved quite a lot. Adverse event start date was 08Mar2021 10:00 AM. Since the vaccination, the patient has not been tested for COVID-19. Unknown if treatment received for ears started feeling like they were stopped up and nose started feeling stuffy. Outcome of what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain was recovered. Outcome of felt flushed and face was red was recovering and outcome of other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
72 2021-03-24 cough, productive cough Persistent hypoxemia as well as intermittent cough and sputum production along with shortness of bre... Read more
Persistent hypoxemia as well as intermittent cough and sputum production along with shortness of breath , required hospitalization.
72 2021-03-31 malaise angioedema; Face itching; feel unwell; my face was swelling, dark red; my face was swelling, dark re... Read more
angioedema; Face itching; feel unwell; my face was swelling, dark red; my face was swelling, dark red/Palms of both hands were swelling and dark red/feet turning red; Palms of both hands were swelling and dark red.; Wheezing; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient (Not pregnant at the time of vaccination) received first dose of bnt162b2 (Batch/Lot Number: EN6198), via an unspecified route of administration in left arm on 03Mar2021 10:45 as single dose for covid-19 immunization. Relevant medical history included: Heart disease, HTN (hypertension), asthma, hereditary factor X deficiency, breast cancer 5 years ago all from an unknown date and unknown if ongoing. The patient was allergies to Lisinopril and povidone-iodine (BETADINE). The patient's concomitant medications were not reported. The patient experienced angioedema, face itching, feel unwell, face was swelling, dark red, dark red/palms of both hands were swelling and dark red/feet turning red, palms of both hands were swelling and dark red, wheezing on 05Mar2021 17:00. The patient felt fine on the 1st and 2nd day post vaccination. Thrilled to finally get 1st dose Pfizer. On 05Mar2021, she began to feel unwell. She looked in mirror, her face was swelling, dark red. Palms of both hands were swelling and dark red. Also feet turning red. Wheezing. Face itching. She was a retired nurse and she knew this was angioedema. Her husband drove her to ED (emergency department). She was given methylprednisolone sodium succinate (SOLUMEDROL) IM and prescription for prednisone. The outcome of events was not resolved. The events resulted in emergency room/department or urgent care. Treatment included: IM methylprednisolone sodium succinate (SOLUMEDROL) in ED and oral prednisone for 3 days. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, has the patient hasn't been tested for COVID-19.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of the suspect drug cannot be excluded in the development of the reported events. Relevant medical history includes allergies to lisinopril and betadine, which suggests potential for drug allergies. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
72 2021-04-01 sweating Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hos... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hospital for her first covid vaccine. After approximately 10 minutes vaccination, she started feeling dizzy, light headed, slightly nauseated. Reports sweating and cold hand. Patient was taken to the emergency department and later admitted to the hospital with new onset afib/aflut with RVR following first dose of Pifzer Covid-19 vaccination. Further workup revealed reduced EF on ECHO and elevated LFTs. Patient was treated and discharged home.
72 2021-04-04 fever Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion,... Read more
Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion, inability to speak or find correct words for communication, sitting up on her own, incontinent episode x1, admitted to hospital for fever, vaccine reaction, discharged home
72 2021-04-07 fatigue woke up with body aches, fatigue, muscles just hurt, 2nd COVID vaccine on Tuesday. Had COVID back in... Read more
woke up with body aches, fatigue, muscles just hurt, 2nd COVID vaccine on Tuesday. Had COVID back in October 2020, Took 400 mg ibuprofen PTA.
72 2021-04-11 cough, fatigue Pt received first dose of the Pfizer COVID 19 vaccine on 3/30/2021. She presented to the ED on 4/1... Read more
Pt received first dose of the Pfizer COVID 19 vaccine on 3/30/2021. She presented to the ED on 4/11/2021 with fatigue, cough, hypokalemia, and generalized weakness. She was admitted to an inpatient unit and tested for COVID-19 which came back positive. Anticipated discharge is today, 4/12/2021
72 2021-04-17 respiratory tract congestion, cough congestion in her chest; The congestion in her chest is, she knows it's there, it's tight,; cough; a... Read more
congestion in her chest; The congestion in her chest is, she knows it's there, it's tight,; cough; arm was sore; This is a spontaneous report from a contactable consumer (patient) reporting for herself. This is report 1 of 2. A 72-year-old consumer (female) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266, Expiry date: May2021) via an unspecified route of administration on 25-FEB-2021 at left arm around 11:30 -12:30 and patient received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8730/GR8730) via an unspecified route of administration on 25Mar2021 both as a single dose for COVID-19 immunization. Medical history and concomitant medication reported as diabetes and blood pressure medicine (From: Unspecified To: Ongoing), has since about 2015 or 2013 or something like that. She declines to provide her medication. She is not a serious diabetic. Sometimes she does not have to even take the diabetes medication because she keeps her A1C is so low she doesn't have to take the diabetes shots. She did not receive any other vaccines within four weeks prior to the vaccination. She didn't have any other real problems with the first dose of Pfizer COVID-19 Vaccine other than her arm getting sore. For her second Pfizer COVID-19 Vaccine she don't have to bother her arm. She had a little cough started sometime last week before she took the second Pfizer COVID-19 Vaccine. The cough doesn't happen all the time. She was coughing quite regular every 2-3 minutes before. She got the Diabetic Tussin cough syrup which has no sugar or alcohol. After taking that cough started quieting down. She was asking is it a regular cough or did the Pfizer COVID-19 Vaccine cause the cough. She's taking it once a day sometimes twice a day. It is nasty cause it's got nothing in it. Maybe she is not taking it enough, it says to take it every 4 hours, maybe she is not taking it enough, she does not know. She is taking it maybe once or twice daily, maybe she takes it more. She reports it's not a constant cough. She also has some congestion in her chest. The congestion in her chest it's tight, she just knows it's there. Her chest congestion is staying about the same. If she gets rid of the cough, she'll get rid of the chest congestion she guesses. Caller reported that people are not educating themselves on these shots, referring to the Pfizer COVID-19 Vaccine shots. They'll tell you it's gone kill you; that she does not believe because some people have died, they took the shot and they didn't get a chance to take the second shot and they passed away. And they are telling her not to get the vaccine because it's going to hurt her. She's going to put it in God's hands and take that Pfizer COVID-19 Vaccine to help prevent or at least have it in her system. She's 72 years old and concerned about herself. The outcome of the event arm sore is unknown, little cough with outcome recovering, congestion in her chest outcome not recovered. Follow up (29Mar2021): This is a Follow-up spontaneous report received from a contactable consumer reporting patient information, event information, concomitant medication. Follow-up attempts are needed. Information on lot/batch number was obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021347466 Pfizer
72 2021-04-17 fatigue, chills faint; tired; chills; mild diarrhea; This is a spontaneous report from a contactable consumer (patie... Read more
faint; tired; chills; mild diarrhea; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received bnt162b2 dose 1 intramuscular in right arm on 13Feb2021 16:00 PM (Lot number unknown) at single dose for COVID-19 immunization. The patient had known allergies to penicillin and shellfish. Other medical history was not provided. The patient's concomitant medications included atorvastatin, vitamin, fish oil, probiotic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient became faint, tired and had chills which caused mild diarrhea from 13Feb2021 05:00 PM. The patient did not receive treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient received the bnt162b2 dose 2 intramuscular in Right arm on 06Mar2021 01:15 AM (Lot number unknown) at single dose for COVID-19 immunization. The outcome of the event events was recovered. Information on the lot/batch number has been requested.
72 2021-04-17 throat pain, malaise, fatigue, cough, sweating, fever, sleepiness hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/cli... Read more
hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195; Drenched in sweat/sweating/sweating like a dog in the middle of the night; Wasn't feeling well; Tightness in chest; Cough; Sinuses congested; Sore; Puffy, bubbled up arms, inflamed; Puffy, bubbled up arms, inflamed; Feverish/felt hotter than usual; Really, really tired/wiped out tired; so sleepy; Sore Arm/her arm started to hurt; Nauseous; Sore Throat/throat hurts; eyes half closed/eyes closing; Puffy Face; blood clot; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733, expiry date: unknown), via an unspecified route of administration, on 29Mar2021 11:45, as single dose, for COVID-19 immunisation. Medical history included ongoing latex allergy (developed welts where the straps met the skin) diagnosed 20-30 years ago; ongoing dye allergy (developed warm soreness to leg, tightness in the chest, could not breathe) diagnosed many years ago; sulphite allergy (diagnosed about 1975-1980; cannot eat processed foods, bleached foods, frozen pre-made foods; tries to eat only single item foods; last anaphylactic reaction after eating olive oil at a restaurant because it had sulphites in it; Mother was possibly allergic to sulphites; Son also allergic to sulphites); and blood pressure that runs low. The patient previously took epinephrine and experienced epinephrine allergy; ciprofloxacin (CIPRO) and experienced Cipro Allergy (eyes closed, got puffy, couldn't breathe); amoxicillin for abscessed tooth and had a reaction because of the sulphites in it; epinephrine (EPIPEN) and experienced epinephrine allergy (does not use it anymore); plantago ovata (METAMUCIL) which she then found out the orange one had sulphites. Historical vaccine included flu shot for immunization and she experienced 104-degree temperature and was sick as a dog and she went to the emergency room (she had flu shot maybe 3 times). Ongoing concomitant medication included multivitamins. The patient got her first dose of BNT162B2 on 29Mar2021 at 11:45. On the same day, once she got home, she became really, really tired/wiped out tired; was so sleepy; experienced sore arm/her arm started to hurt; was nauseous; had sore throat/throat hurt; eyes half closed/eyes closing and puffy face. On 30Mar2021, the patient experienced elevated pulse/her pulse got too high/pulse was 165 beats per minute/climbed up to 195. Her heart rate was 194 at some point for a couple of minutes then stayed at 165 for a long time. She hoped she wasn't having a heart attack. She had tightness in her chest, wasn't feeling good and was coughing. She stayed in her bed to wait out her symptoms. These lasted for 10 minutes (as reported). She started meditating hoping her heart rate would decrease and it did after about 15-20 minutes. The patient also felt feverish/felt hotter than usual. Before she took the vaccine on 29Mar2021, her temperature was at 96. She stated that her temperature usually runs low as 95-06 degrees. She also felt like her sinuses were congested; was sore; had puffy, bubbled up arms, inflamed. The patient hoped it was not a blood clot she developed. At the time of the report, the patient stated that her heart rate was 61 beats per minute, earlier it was in the 70s; and her temperature was at 96.3. Her second dose is scheduled on 19Apr2021 and mentioned that if these were her reactions with the first dose, she is questioning getting the second dose. The outcome of "blood clot", "hoped she wasn't having a heart attack", "Wasn't feeling well", "Tightness in chest", cough, and sinuses congested was unknown. The patient recovered from "Drenched in sweat/sweating/sweating like a dog in the middle of the night", and "Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195" on 30Mar2021; and was recovering from "Sore Arm/her arm started to hurt", and "eyes half closed/eyes closing". The outcome of the remaining events was not recovered. Information on the lot/batch number has been obtained. Additional information is expected.
72 2021-04-20 headache, fever, dehydration, sweating, chills Dry heaves; diarrhea; headache; ringing in her ears; dizziness; fever; chills/ shaking with chills; ... Read more
Dry heaves; diarrhea; headache; ringing in her ears; dizziness; fever; chills/ shaking with chills; sweats; Freezing; dehydrated; This is a spontaneous report from a contactable consumer who reported for herself. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ER8732, via an unspecified route of administration, administered in left arm on 25Mar2021 at 16:30 as single dose for COVID-19 immunisation. Medical history included ongoing osteoarthritis. She had severe osteoarthritis and took medication for the arthritis pain. She said she had been taking the osteoarthritis pain medication for a couple years. Concomitant medications were not reported. Patient has no additional vaccines administered on same date of the Pfizer vaccine and has no prior vaccinations (within 4 weeks). Patient with a history of severe osteoarthritis said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 25Mar2021. The next day on 26Mar2021, she had terrible diarrhea, headache, ringing in her ears, dizziness, fever, chills and sweats. She was admitted to hospital from 29Mar2021 to 31Mar2021. Consumer wanted to know if she should still receive the 2nd dose. She further reported that she got her COVID-19 Vaccine late in the afternoon on 25Mar2021. She said she seemed fine after she got her COVID-19 Vaccine. She said the next morning on 26Mar2021, she woke up with terrible diarrhea, (really bad) headache, ringing in her ears, and dizzy. She said everything went sideways on 26Mar2021. She clarified she also had the chills, was soaking wet with sweat (but never seemed to have a fever). She said she was either sweating, freezing, or shaking with chills. She said she kept having diarrhea. She said on 29Mar2021 she had dry heaves with the diarrhea, and finally went to the Emergency Room. She said while she was at the hospital, she overhead hospital staff saying they thought she had the COVID-19 Virus. She said she treated as if she had the COVID-19 Virus by the hospital staff. She said she had a negative COVID-19 Virus nasal swab test, and the negative COVID-19 nasal swab test had come back within an hours-time on 29Mar2021. She said she was admitted to the hospital because she was dehydrated, and the doctor wanted to make sure she was over her diarrhea and getting better. The adverse events required a visit to the emergency room. She said she was hesitant about getting the second COVID-19 vaccine because of her severe side effects. She had blood work and a urinalysis done at the hospital in Mar2021. Diarrhea and dehydration treatment: Reported she took 3 doses of anti-diarrheal medication on 27Mar2021, and another dose on the morning of 29Mar2021 before she went to the Emergency Room. She said her diarrhea had kind of stopped after the morning of 29Mar2021, because she was unable to provide a stool sample when she went to the Emergency Room. Reported while she was admitted to the hospital, she was given IV fluids. She said she was unsure which IV fluids she was given. Patient reported she had recovered completely from all her reported symptoms in Mar2021.
72 2021-04-20 malaise, headache, chills loses her voice; she just sat down in a chair, and everything went black for a second; second COVID-... Read more
loses her voice; she just sat down in a chair, and everything went black for a second; second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021; second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021; She hurt more, too, in her L4 & L5 vertebrae; not feeling well; body was aching/She hurt more, too, in her L4 & L5 vertebrae, and had pain throughout her whole body.; Headache; Chills; Her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose; Her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 24Mar2021 13:53 (at 72-years-old) as single dose for COVID-19 immunization. Medical history included ongoing Spinal leak (Diagnosed with a spinal leak about 1-1/2 years ago. She said she has had spinal leaks, on and off, since that time.), ongoing Oral lichen planus (Stated she was diagnosed with Oral Lichen Planus between 10-15 years ago), ongoing Rheumatoid arthritis (Stated she was diagnosed with Rheumatoid Arthritis at least 3 years before she was diagnosed with Oral Lichen Planus. She said she had been tested for food allergies & as long as she stayed away from gluten, chicken, tomatoes & some other things, she did not have a problem with her rheumatoid arthritis. She said gluten, in particular, triggered her rheumatoid arthritis.), Gluten (triggered her rheumatoid arthritis), fractured her L4 vertebrae in last summer 2020, sciatica from Feb2020 (pinched sciatic nerve since Feb2020), Bone density issue. Stated her family has a history of autoimmune diseases, like Lupus. Concomitant medications included diphenhydramine, paracetamol (EXTRA STRENGTH TYLENOL PM, NDC Number: 50580-937-19, Lot Number: SLA006, Expiration Date: Aug2024); ibuprofen (ADVIL, UPC Number: 305730154604, Lot Number: EG1007, Expiration Date: Jul2023); gabapentin ("ACI Health", Expiration Date of 05Mar2022). The patient previously took first dose of bnt162b2 (Lot number: EN6198) on 02Mar2021 (at 72-years-old) Intramuscular on left arm for covid-19 immunization but experience Left arm was sore, left arm soreness went away after 2-3 days. The patient previously took Flu vaccine but experienced Mouth sores. Reported she had both COVID-19 Vaccine doses. She said she got the typical side effects of a headache, chills, not feeling well, and her body was aching. She clarified those side effects started late the night of her second COVID-19 Vaccine shot (24Mar2021). She said those side effects were mild, and resolved in about 2 days. She said she didn't think much of those side effects, until the next day (25Mar2021), when the other side effects started (blacked out, lightheaded, equilibrium was off). She said her left arm was sore after her first COVID-19 Vaccine dose. She said she didn't treat her left arm soreness, and the left arm soreness went away after 2-3 days. Reported on 25Mar2021 at about 11:30AM, she blacked out. She said she just sat down in a chair, and everything went black for a second. She said she then got really lightheaded, and her equilibrium was off. Reported she had spinal leaks, on and off, for the past 1-1/2 years. She clarified that her doctors didn't think the spinal cord leaks would be contraindicated with the COVID-19 Vaccine. She said all her doctors said it was up to her if she wanted to get the COVID-19 Vaccine because she previously had problems with the flu vaccine. She clarified she had a flu vaccine about 15 years ago, and the day after the flu vaccine, she got mouth sores, and the mouth sores got worse. She said her local doctors didn't know how to treat her mouth sores, so she went to the clinic. She said the clinic doctors told her she had Oral Lichen Planus, and the Oral Lichen Planus was caused by the flu vaccine she had received. She stated she did not have any information (NDC, Lot, & Expiration Date) for the flu vaccine she received back then. She stated she has not had a flu vaccine since that time. Reported her spinal cord leaks caused equilibrium, and lightheadedness. She said she thought her second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021 11:30. She said her lightheadedness, and equilibrium being off was still going on. Reported she hurt more, too, in her L4 & L5 vertebrae, and had pain throughout her whole body. She clarified she fractured her back (specifically her L4 vertebrae) last summer (2020), and her L4 vertebrae had since healed. She said she had a pinched sciatic nerve since Feb2020. She clarified her L4 and L5 vertebrae move because she had 3 blood patches to treat her spinal cord leaks. She said when the blood patches were done a lot of force was used to stop the spinal leaks. She said the first blood patch caused her buttocks to really hurt. She said she had 2 more blood patches. She said she was not too sure about second blood patch, but with the 3rd blood patch, she was miserable. She said she had physical therapy weekly, and she may have to have her back fused. She said she had a bone density issue that apparently was mentioned in her medical records when she was in her 50s. She said she was never treated for her bone density issue until after she fractured her L4 vertebrae in 2020. No further details provided. Reported her last blood work was 3-4 months ago. No further details provided. Reported her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose (Mar2021). She clarified she started to get Oral Lichen Planus mouth sores a couple days after she received her second COVID-19 Vaccine. She said she can go months without having any issues, and then get the Oral Lichen Planus mouth sores. She said she took medication to manage her Oral Lichen Planus. She said with the medication, the Oral Lichen Planus mouth sores are gone within 24-48 hours. She said with her latest Oral Lichen Planus mouth sores, she put her medication on the mouth sores, and the mouth sores seemed to settle down, but the mouth sores didn't go away completely. She said the day before yesterday (03Apr2021), her Oral Lichen Planus mouth sores got worse again, and are staying that way, even with using the medication. Oral Lichen Planus Treatment: Stated she was applying Clobetasol Propionate Ointment UPS 0.05% to her mouth sores after she eats, or about 3-4 times a day. NDC Number: 51672-1259-6, Lot Number: 332450, Expiration Date: Aug2021. For other treatment she had medication she takes every day, and she continued to take the medication to help her symptoms. She said she had physical therapy twice a week for about 1-1/2 hours, as well as, doing physical therapy on her own. She clarified she does the physical therapy for her sciatica and vestibular issues, saying she was not steady on your feet. She said she does physical therapy about 4 hours a week. Reported her doctors told her she would not survive the Corona Virus if she were to get it because of her underlying health issues. No further details provided. Reported her doctors said there was no information reporting that the COVID-19 Vaccine was contraindicated in people with spinal cord leaks, and how the COVID-19 Vaccine would affect people with spinal cord leaks. She said she thought she may have been fighting things because the COVID-19 Vaccine was acting like the flu vaccine (when she first developed Oral Lichen Planus). She said she thought her symptoms after her second COVID-19 Vaccine dose may have had something to do with her spinal cord leak because she had similar symptoms (lightheadedness & equilibrium issues) with her spinal cord leak. She said with her spinal cord leak, she also had pain and loses her voice. No further details provided. The outcome of the events she just sat down in a chair, and everything went black for a second was recovered on 25Mar2021; headache was recovered in Mar2021; chills was recovered in Mar2021; not feeling well was recovered in Mar2021; body was aching/she hurt more, too, in her l4 & l5 vertebrae, and had pain throughout her whole body was recovered in Mar2021; loses her voice was unknown; while for other events was not recovered.
72 2021-04-23 chills, fever, headache she had a 102°F temperature/her temperature that went up to almost 102; headache/bad headache/horri... Read more
she had a 102°F temperature/her temperature that went up to almost 102; headache/bad headache/horrible headache; nausea; chills; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), second dose via intramuscular in upper left arm on 09Feb2021 at 16:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot number: EL3249) via intramuscular in upper left arm on 19Jan2021 at 17:30 as single dose for COVID-19 immunization. In Feb 2021, about 30 hours after the second vaccine, the patient experienced 102 degree Fahrenheit/her temperature that went up to almost 102, headache/bad headache/horrible headache, nausea and chills. The patient underwent lab test and procedures which included body temperature was 102 degree Fahrenheit. Therapeutic measures were taken as a result of the events include baby aspirin. Then three hours later she took two more baby aspirin and her temperature went down after each time she took aspirin, states everything went down after the aspirin, the chills, nausea, and headache went down. She was reading literature and it looks like by taking an aspirin she may have stopped the production of antibodies. She is asking if this is true and if she has to be revaccinated or what she has to do. By the time she stared to go to bed she started to get a headache. She clarified that all of her other symptoms started in the middle of the night the same day she received the second dose. By 11Feb2021, in the early morning around 01:30am or 04:30am (both of the times she took aspirin) she recovered from all the side effects except she still has a very slight temperature. By 09:00 on 11Feb2021, her temperature was down to 100 or 99. The outcome of the event pyrexia was recovering, and was recovered for headache, nausea and chills.
72 2021-04-24 fatigue Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racin... Read more
Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding; Arm barely sore; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 72-years-old , via an unspecified route of administration, administered in Arm Left on 31Mar2021 11:40 am as single dose for covid-19 immunisation. Medical history included ongoing food allergy, she had anaphylactic shock from a food allergy (she was 40 at the time and she doesn't eat anything she is allergic to), sinus infection and then got horrible hives under her eyes. No Prior Vaccinations (within 4 weeks). Concomitant medication was eye drops every night. No additional vaccines administered on same date of the Pfizer Suspect. The patient previously took epipen had two episodes when she was 40. She is bad about carrying her EpiPen, she forgets it. She was allergic to Amoxicillin. At 11:40 am last Wednesday patient had the vaccine, and around 4 or 5 pm, her heart started pounding for 10 seconds, and it felt like forever. An hour later, her heart started pounding again. It happened twice an hour apart and the second time lasted longer. It described as hard pounding. It started at 4 or 5 pm and then for 4.5 hours there was nothing, but then her heart started racing. At around 4 or 5 pm her heart was pounding, than around 9:30 pm her heart started racing and beating fast, she could feel it. She lives in a rural community and her husband called the local fire station and asked if he could take her there, to the station, so that she could have her heart checked. She was hooked up to a monitor and the paramedics said that she had an irregular arrhythmia and needed to go to the hospital by ambulance. Her heart rate was 115 to 130 beats, then 140 beats, at the hospital. It was about 11pm when she was evaluated and then left in the ambulance, as she was 45 minutes from the hospital. The paramedics would have, the arrhythmia, on record and that 5 minutes before she got to the hospital, the paramedic said her heart rhythm was normal. She was not admitted to the hospital, but held in observation and left the hospital at 4:30 in the morning. She hasn't felt anything after that. it was only one time she thought her heart was going faster, after that, but it didn't happen again. It is currently no problem and even at the hospital, the heart racing stopped and it was normal. The doctor in the emergency room said she was totally normal. Her arm was barely sore, when touched, and noticed this when she was being helped to the bathroom in the emergency room, maybe later in the afternoon, it was not hurting. But she didn't have any other events. She was tired the next day on 01Apr2021. She was up all night in the emergency room. people say that one will be tired, as an effect, but she can't say that it is because of the vaccine, or if she only had 3 hours of sleep. She hasn't been sleeping but she can't attribute it to the vaccine. She can't attribute this to the vaccine, that she has been tired lately and not sleeping. Event outcome of irregular arrhythmia and Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding was recovered on 31Mar2021, of Arm barely sore was recovered on 02Apr2021, of the remaining was unknown. Information about Batch/Lot number has been requested.
72 2021-04-24 malaise Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pai... Read more
Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pains; violently ill; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient' medical history and concomitant medications were not reported. The patient experienced vomiting and diarrhea. Mostly diarrhea. The vomiting started 05Mar2021 in the middle of the night. She was vomiting so much she went to the Emergency room by ambulance. They kept her in the hospital for a couple of days, but she did not have diarrhea at this time. It was like three days later that she suddenly became violently ill. At the time she did not tie it to the vaccine administration, she thought she had food poisoning or something. She then had severe diarrhea. She cannot recall the exact onset date of when the diarrhea began. She can't get the dates together because she knows she became very sick. Patient recalls that when she got out of the hospital, she was having stomach pains. The stomach pains were feeling more severe on 18Mar2021. On 19Mar2021, she went to a check up with her gynecologist for an annual check up and did tell her gynecologist about the stomach pain and having a lot of stomach issues, but the doctor had no idea about it, she's a gynecologist. The patient's gastroenterologist thought maybe she had diverticulitis not related to the Pfizer COVID-19 vaccine and on 27Mar2021, they started her on Cipro and Flagyl, but the diarrhea just kept getting worse even with the meds and its just been getting worse and worse and worse. Cipro and Flagyl were stopped after 5 days because her gastroenterologist told her that maybe all of her flora was cleared out, and the flora was causing the diarrhea. No one knows what was causing her diarrhea. Oddly enough, she was feeling a little better today. She feels like she doesn't have diarrhea today, but she doesn't know because sometimes she has diarrhea for a couple of hours and then she feels just fine for a couple of hours. She also has brain fog. She was feeling like she could not think straight. She confirmed she does not have this feeling today. It got really bad after the second shot. The brain fog started between the time of first and second shot, when she had the diarrhea. It was like a week to ten days after the first shot, but she does not know exactly when brain fog started. It comes and goes, doesn't have it right now, and didn't have it yesterday. She stated that the brain fog seems to have gone away about 5 days ago. She had all these blood tests and cat scan and they all came back negative that she is in perfect health. She has no other issue except this constant diarrhea. Caller states she doesn't have any issues with any of her abdominal organs, her gall bladder and intestines are all fine. She has lost 5 pounds explaining that a month ago she weighed 136 pounds and now she weighs 130 pounds. The diarrhea is without any known medical known ideology and is very debilitating because she has lost a lot of weight. The outcome of events was reported as "unknown". Follow-up attempts are completed. The following information on the batch number has been requested.
72 2021-04-26 cough, nasopharyngitis 107 °F fever; a bit of a cold the same night she got vaccinated; Blood Pressure Elevated; Cough; He... Read more
107 °F fever; a bit of a cold the same night she got vaccinated; Blood Pressure Elevated; Cough; Heart Rate Elevated; Felt palpitations; This is a spontaneous report from a contactable other health care professional. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 09Apr2021 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Thyroid Condition States was diagnosed about 23 years ago, ongoing High Blood Pressure Diagnosed 3-4 years ago. Concomitant medications included ongoing levothyroxine taken for thyroid condition; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) taken for hypertension. On an unspecified date, the stated she had a 107 °F fever, "a bit of a cold the same night she got vaccinated, took amoxicillin and is responding good." On 09Apr2021, the blood pressure elevated, cough, Heart Rate Elevated, Felt palpitations. The patient underwent lab tests and procedures which included blood pressure measurement: 140 some high blood pressure problems, sometimes it goes to 140, blood pressure measurement: 170 on an unspecified date blood pressure went up as high as 170, blood pressure measurement: 157/68 on an unspecified date her blood pressure is still going up at times 157/68, body temperature: 107 fahrenheit on an unspecified date 107 °F fever, heart rate: 102 on unspecified date Her heart rate was also 102 , heart rate: 82 on unspecified date Her heart rate is 82. The outcome was recovering. Relatedness of drug to reaction(s)/event(s): Reaction assessed : Blood Pressure Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result : Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Cough. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Heart Rate Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection; Sender's Comments: Based on the current available information after FU and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hyperpyrexia cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
72 2021-04-28 headache, fatigue mild stroke; loss of taste and smell; loss of taste and smell; fatigue; headache; This is a spontane... Read more
mild stroke; loss of taste and smell; loss of taste and smell; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN8732) via an unspecified route of administration on 23Mar2021 at 08:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, and a-fib (atrial fibrillation), all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications ("other medications in two weeks") included carvedilol, hydrochlorothiazide and losartan, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 24Mar2021 the patient experienced loss of taste and smell, fatigue and headache and on 26Mar2021 the patient experienced mild stroke. All events resulted in an emergency room visit and resulted in hospitalization from 26Mar2021 to 29Mar2021. The clinical course was reported as follows: "Second dose on 23Mar2021, loss of taste and smell, fatigue, headache on 24Mar2021 and 25Mar2021. Went to (Hospital name) on Friday 26Mar2021 and diagnosed with a mild stroke. Stayed in hospital until Monday 29Mar2021. Prescribed a blood thinner (Eliqus) per already engaged cardiologist. As of 13Apr2021 still no taste or smell; gaining energy." Therapeutic measures were taken in response to the adverse events and included treatment with "medications to lower blood pressure and a blood thinner". The patient underwent a nasal swab COVID-19 test post vaccination on 26Mar2021 which was negative. The clinical outcomes of the events loss of taste and smell were not recovered; mild stroke, fatigue and headache were recovered/resolved on unspecified dates.
73 2021-01-05 headache The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the pat... Read more
The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the patient called complaining of right eye drooping, right facial tingling, mild shortness of breath, facial flushing and new onset headache. She arrived at ED at 2:06 pm presenting with facial swelling, tingling and shortness of breath. At that time, she stated her shortness of breath had actually improved and stated "probably just nerves". She still had a funny sensation in her face. She denied any focal numbness or weakness in her extremities. She stated she felt a little lightheaded. She had no sensation of throat swelling, difficulty swallowing. Physical Exam in ED: Constitutional: She appears well-developed and well-nourished. HENT: Head: Normocephalic and atraumatic. Eyes: EOM are normal. Neck: Normal range of motion. Cardiovascular: Normal rate and regular rhythm. Pulmonary/Chest: Breath sounds normal. No respiratory distress. Abdominal: Soft. There is no abdominal tenderness. Musculoskeletal: Normal range of motion. Neurological: She is alert and oriented to person, place, and time. Patient has symmetric facial numbness, she has right periorbital swelling causing what appears to be a facial droop however her mouth seems symmetric, she has negative Romberg's, she has full strength and symmetric sensation throughout Skin: Skin is warm and dry. Psychiatric: She has a normal mood and affect.
73 2021-01-06 influenza like illness, fatigue Lot# is on card at work. Had COVID in April. Flu like symptoms. Tired, ached from head to toe. No ap... Read more
Lot# is on card at work. Had COVID in April. Flu like symptoms. Tired, ached from head to toe. No appetite. Went home and slept for 5 hours. Next day felt a little better. Today she is back to normal.
73 2021-01-08 chills, fever, headache Headache, Myalgia, Fever, NauseaVomiting, Chills Narrative:
73 2021-01-11 fatigue, headache Arm pain; headache; tiredness; extreme weakness; This is a spontaneous report from a contactable con... Read more
Arm pain; headache; tiredness; extreme weakness; This is a spontaneous report from a contactable consumer (reported for herself). A 73-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 05Jan2021 13:15 at single dose at left arm for COVID-19 immunization. Medical history included High cholesterol, Fibromyalgia, Protein S Deficiency, Anxiety, known allergies: Scallops. Concomitant medications received in two weeks included warfarin, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluoxetine, clonazepam (KLONOPIN), rosuvastatin calcium (CRESTOR), fenofibrate (FENOFIBRAT). Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, the patient experienced Arm pain, headache, tiredness, extreme weakness. No treatment was received for the adverse events. The report was non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
73 2021-01-19 fatigue, body temperature increased, chills 1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping... Read more
1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping 10-11 hours on both nights. 1/17/2021 Chills and temperatures between 99 and 101.2 degrees 1/18/2021 Temperature of 100.1 degrees in the morning with gradual decline to 98.9 degrees in the evening 1/19/2021 and 1/20/2021 Temperature normal 1/13/2021 to 1/15/2021 Injection site "sore" 1/15/2021 Injection site became hard and painful to the point where I was not able to move the arm without pain at the level of 10 or above which of course limited my use of the arm 1/20/2021 Injection site still painful and difficult to lift or move the arm without pain at a level of 4-5.
73 2021-01-19 throat pain, fatigue Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swel... Read more
Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swelling back of roof of mouth and tenderness neck glands unilaterally. Difficult/painfulswallowing -takes considerable effort to swallow.
73 2021-01-19 fever Low grade fever with Tylenol( 99.6)
73 2021-01-22 fatigue Started feeling fatigued day of shot. Next morning very tired and throughout day, slightly aching mu... Read more
Started feeling fatigued day of shot. Next morning very tired and throughout day, slightly aching muscles all day as well. No other symptoms.
73 2021-01-24 fatigue, fever Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body ac... Read more
Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body aches and no strength. Caregiver stated on 1/23/2021 patient was having same symptoms with loss of appetite and fatigue. On 1/25/2021 caregiver noticed 2x2 red spot around the injection site that warm sore to touch. Caregiver reached out to the PCP and was told to keep an eye on red spot and put a damp warm rag on it.
73 2021-01-24 fever Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still ther... Read more
Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still there at 5 days after vaccination.
73 2021-01-24 headache STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME... Read more
STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME WORDS, DIFFICULTY SIGNING NAME, HIGH bp WAS ADMINISTERED EMERGENCY CLOT BUSTING DRUG IV AND THEN TRANSFERRED TO NEUROLOGY HOSPITAL. SYMPTOMS OF SLURRED SPEECH, DISAPPEARED NEXT DAY, WRITING HAND RETURNED TO NORMAL RAPIDLY AFTER IV. SLIGHT HEADACHE REMAINED FOR A COUPLE OF DAYS
73 2021-01-25 headache, throat pain, fever Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy and sharp ... Read more
Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy and sharp pain pain in eyes hoarse throat
73 2021-01-26 headache, malaise, fatigue, chills Headache, chills ,feeling unwell, tiredness
73 2021-01-26 malaise Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood press... Read more
Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood pressure was 198/91. Per clinical nursing director, EMS called. EMS checked vitals again and blood pressure was 130/82. At that time EMS and patient decided that patient did not need to be transported to hospital at this time. Patient left with husband. At time of departure patient was oriented and reported feeling well.
73 2021-01-26 cough, chills, runny nose, throat pain Woke up with mild symptoms - a runny nose, intermittent mild chills, cough and sore throat. Lasted ... Read more
Woke up with mild symptoms - a runny nose, intermittent mild chills, cough and sore throat. Lasted 24 hours. I mention this, though 6 days after the vaccine because of my immunocompromised state.
73 2021-01-27 headache Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection... Read more
Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection site
73 2021-01-27 runny nose Runny Nose 48 Hours after receiving vaccination
73 2021-01-28 fatigue, throat pain, nasal congestion, headache 1/24/21 woke with body ache, nasal congestion, headache 1/25/21 same symptoms plus sore throat and f... Read more
1/24/21 woke with body ache, nasal congestion, headache 1/25/21 same symptoms plus sore throat and fatigue 1/26/21 all of the above symptoms plus loss of taste and smell 1/27/21 all of the above 1/28/21 all of the above No fever at any time
73 2021-01-28 fever, chills, fatigue, headache Aching joints of the wrists, knees and ankles. Fever, chills and dull headache. Fatigue. By the seco... Read more
Aching joints of the wrists, knees and ankles. Fever, chills and dull headache. Fatigue. By the second day, symptoms had disappeared and I felt fine! Temperature was normal, just slight fatigue.
73 2021-01-28 nasal congestion, fatigue, headache This is a spontaneous report from a contactable other health professional. A 73-year-old female pat... Read more
This is a spontaneous report from a contactable other health professional. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EV0140, via an unspecified route of administration in the left arm on 03Jan2021 13:00 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Patient was not pregnant at vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included Simvastatin, Gabapentin, Flonase, Claritin and multi (not specified). The patient previously took codeine and experienced allergy. Within two days (on 05Jan2021), patient experienced headaches, body aches, fatigue, nasal congestion. Strength not yet fully recovered ten days out. The outcome of events was recovering. Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
73 2021-01-28 throat pain after second dose of vaccine, patient had Internal jugular (IJ) vein thromboembolism, acute, right; ... Read more
after second dose of vaccine, patient had Internal jugular (IJ) vein thromboembolism, acute, right; Mucositis; Sore throat. Admitted for Chemotherapy-induced neutropenia; Infection of venous access port. Discharged after one day.
73 2021-01-28 chills, fatigue, headache, influenza like illness overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, na... Read more
overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, nausea, dizziness (the last two symptoms were brief)
73 2021-01-29 fatigue, chills Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep b... Read more
Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep breaths. Them couldn't get warm. Shivering. Felt fevered but no elevated temp registered. Lasted about another hour. Tired/weak after. Noal next day.
73 2021-01-31 fatigue, influenza like illness, chills Flue like symptoms, right arm hurt and felt very cold, body ached, , felt dizzy like vertigo, had th... Read more
Flue like symptoms, right arm hurt and felt very cold, body ached, , felt dizzy like vertigo, had the chills, needed to sleep. went to bed early around 8 and slept through the night getting up once to go to the bathroom. Has breakfast just toast the next morning and had to get back into bed and slept 4 more hrs. Body still aching. slept with heating pad and iced my arm. I felt a little better the next day around 2 pm. I drank lots of fluids and rested the rest of the day. Next day still felt weak. 3 days later feeling ok. I am worried about my next vaccine due on the 14th of Feb. Would like to know what to take. My doctor referred me to you with no instructions......
73 2021-01-31 headache Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she c... Read more
Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she can't really describe; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: SL3246), via an unspecified route of administration in right arm, on 12Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took varicella zoster vaccine (SHINGLES VACCINE) for immunization and had a little reaction but just the normal things. On Tuesday morning, the patient got the COVID-19 shot and was fine. This morning (15Jan2021), the patient was not feeling great, has a slight headache, her breathing is heavier, and below her breast line is a tightness she can't really describe. The patient asked if these were a side effect of the COVID-19 vaccine and wondering if this is normal. As a treatment for the events, the patient took paracetamol (TYLENOL). The patient asked if she can or should get a test, a COVID-19 test. It has been so many days since having the vaccine, 4 days later, she is wondering if she might have COVID-19. The patient isn't sure and is just asking a question. It is confirmed that she has not had a test or tested positive for COVID-19. The outcome of "Not feeling great" was unknown. The patient had not recovered from the remaining events.
73 2021-01-31 fever Patient had a fever on Saturday 1-30-2021, from about Noon until about 8 pm. Highest fever was 101.7... Read more
Patient had a fever on Saturday 1-30-2021, from about Noon until about 8 pm. Highest fever was 101.7. I treated it with Ibuprophen, and that successfully reduced the fever. The fever had an adverse affect on her Alzheimer's. the condition was temporary, and by Sunday morning, 1-31-2021, she was back to normal.
73 2021-01-31 fatigue Pinpoint itchy rash on arms, back, chest and abdomen, Noticed at 2:00 AM, 14 hours after shot give... Read more
Pinpoint itchy rash on arms, back, chest and abdomen, Noticed at 2:00 AM, 14 hours after shot given. Very tired feeling. Went to ER for treatment on Sat AM, Was told to take Zyrtec and/or Benedryl and make appt with PCP. Rash gone on Monday 02/01/21. Have appt with Dr , PCP, Wed 02/03/21 for follow up. Will discuss having second shot??
73 2021-01-31 sweating Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjectiv... Read more
Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjective Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness,chest tightness, sweating, and feeling flushed She denied hives, loss of sensation, SOB. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress and tongue swelling. ALLERGY REVIEW OF SYSTEMS Previous Reactions: PCN Objective Vitals Vitals: 01/29/21 1514 01/29/21 1521 01/29/21 1526 01/29/21 1539 BP: (!) 153/97 (!) 154/116 (!) 167/90 (!) 172/84 Pulse: 59 64 59 55 SpO2: 99% 94% 96% 99% Blood Sugar 97 collected at 1500 Physical Exam No Rashes or Hives noted. No facial swelling , no wheezes. HEENT Pharynx is clear without exduate. No facial or tongue swelling. Lungs CTA all wheeze No SOB. Neck is supple. No swelling is noted. pt is anxious and nervous. No sign of anaphalyxis No stridor, no swelling Assessment/Plan Treatment included: antihistamines Benadryl 25 mg, Pepcid 10 mg Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Mild reaction, improving. Pt refused any further medications or assessment at the ER. Her husband will pick her up.
73 2021-01-31 fatigue, headache minor headache to start, but unrelieved 4 days later even with use of Excedrin. On 31 Jan dizziness... Read more
minor headache to start, but unrelieved 4 days later even with use of Excedrin. On 31 Jan dizziness began, becoming persistent on 1 February. Mental fatigue.
73 2021-01-31 fever, chills, fatigue she had a high fever of 102 degrees. She said she had a high fever all night, and her fever was a li... Read more
she had a high fever of 102 degrees. She said she had a high fever all night, and her fever was a little less this morning. She said her last temperature was 100.6; Ache/ Pain/ lingering body aches; Chills; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Apr2021), via an unspecified route of administration on right upper arm on 14Jan2021 12:10 at a single dose for COVID-19 immunization. Medical history included ongoing Blood pressure high diagnosed 8-10 years ago and Arthritis for between 10-15 years started in her finger, and then progressed to other areas of her body. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included Gabapentin. The patient did take her regular prescription medication, Gabapentin last night (14Jan2021; She takes 1 Gabapentin 100mg capsule before she goes to bed each night). On 14Jan2021 19:30, the patient experienced fever of 102 F, chills, body aches and fatigue, lasting all night. Then Fever of 100.6 F during the day (15Jan2021), with some lingering body aches. The patient reported that she had a high fever of 102 degrees. She said she had a high fever all night, and that her fever was a little lower this morning (15Jan2021). She said she checked her temperature a short time ago, and her temperature was 100.6. She said last night (14Jan2021), she had bad aches, pains, chills, and fatigue. She clarified she had a lot of little aches and pains. She said she was not sure if the aches were muscle or joint. She said her aches, pains, chills and fatigue did improve today (15Jan2021). The patient declined any treatment for the events. Reported she was told to not to take anything to treat any symptoms she may experience after receiving the COVID-19 Vaccine. She clarified she was told if her arm hurts at the location she received the COVID-19 Vaccine injection, to not take anything for the arm pain. She said the aches and pains she experienced last night after receiving the COVID-19 Vaccine went to her arthritis spots. The vaccination facility type was hospital. The events did not require a visit to Emergency Room or Physician Office. No prior vaccinations (within 4 weeks). No COVID prior vaccination. Patient was not COVID tested post vaccination. The outcome of the events was recovering.
73 2021-02-01 chills, sweating, headache she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chi... Read more
she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chills; nausea; She had a terrible headache; Feeling freezing cold; she was going to faint; She thought she was losing her mind; slight pain in her arm/sore arm/sore spot; She feels weak, and is still weak; She couldn't walk; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) via an unspecified route of administration in the left arm on 10Jan2021 at single dose for COVID-19 immunization. There was no medical history. There were no concomitant medications. The patient had the first dose of the vaccine on 10Jan2021 and didn't have a reaction, but had a slight pain in her arm on 10Jan2021. Her sore arm started on 11Jan2021. There was a sore spot and when she would pick up her arm it was sore and achy. No pain, but sore and achy. It lasted for a day or two. She didn't have any symptoms until Saturday the 16Jan2021, this past Saturday she thought she was dying. She had chills, nausea, feeling freezing cold, and had a headache. She thought she was losing her mind. The headache just stopped today. She had the chills that would not stop and she thinks she broke the sweat on Sunday (17Jan2021). She had a little nausea and couldn't eat anything on 16Jan2021. She had a terrible headache, which just stopped about 2 hours ago. She stated she must have to take 10 Tylenol over the course of time, every 4 hours. On Saturday 16Jan2021 she was just laying on the floor in pain. She was not even eating, just drinking water. All of her symptoms stopped this morning around 5 AM (18Jan2021). She had a big sweat. She is unsure if she had a fever because she does not have a thermometer. She is unsure if she has recovered completely from these symptoms. She feels weak, and is still weak (on Jan2021). She cannot go out or get dressed or shower. She is not strong enough. She is just sitting up now, no longer laying in bed. She couldn't walk (on Jan2021) and was afraid she was going to faint on 16Jan2021. She can walk a little bit now and feels a little bit better. She has been out of it for three days, She hasn't felt good. She asked if side effects can appear 6 days later? Is this normal to have a reaction 1 week after getting it? She asked are the side effects worse after the second dose? She asked is this Covid or side effects, what are the COVID symptoms? She asked should she take the second one if she had these side effects? Caller clarifies this is the Pfizer COVID Vaccine. Whoever vaccinated her did not give her the paper about it afterwards. Her neighbor brought it to her cause they went together. She did not realize she could experience these things. She did not expect them a week after getting the vaccine. She thought she had COVID. She asks, "do you think I have COVID?" She is just now getting better and it has been 3 days of experiencing these symptoms. Should she get the second vaccine? She is trying to do the right thing. Event outcome of chills, nausea, feeling freezing cold, and headache was recovered on 18Jan2021, for was going to faint and couldn't walk was recovering, for weak was not recovered, while for others was unknown.
73 2021-02-02 fatigue O2 sat 70% on RA; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2... Read more
O2 sat 70% on RA; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; This is a spontaneous report from a contactable physician. A 73-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose intramuscular on 03Jan2021 for Covid-19 immunisation, administered at nursing home/senior living facility. Medical history included alcohol use, diverticulitis, iron deficiency anaemia (IDA), asthma, hypertension, anxiety, recent C. diff infection, allergies to penicillin. She was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included apixaban (APIXABAN), bioflavonoids nos, calcium ascorbate, hesperidin, rutoside, sodium ascorbate, zinc amino acid chelate (VITAMIN C [BIOFLAVONOIDS NOS;CALCIUM ASCORBATE;HESPERIDIN;RUTOSIDE;SODIUM ASCORBATE;ZINC AMINO ACID CHELATE]), cyanocobalamin (B-12), furosemide (LASIX), simethicone (manufacturer unknown), tramadol (manufacturer unknown), vancomycin (manufacturer unknown) oral, omeprazole (PROTONIX), amlodipine (manufacturer unknown), vitamins nos (MULTIVITAMIN), thiamine (manufacturer unknown), aripiprazole (ABILIFY), atorvastatin calcium (LIPITOR), clonazepam (KLONOPIN), folic acid (manufacturer unknown), sertraline hydrochloride (ZOLOFT). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 10Jan2021, 7 days after getting vaccine, the patient developed shortness of breath and fatigue, rheumatoid arthritis, O2 sat 70% on RA, now intubated and in multiorgan failure. The events resulted in Emergency room/department or urgent care, hospitalization, life threatening illness for immediate risk of death from the event. The patient was hospitalized for the events for 18 days. Patient received treatment with corticosteroids, antibiotics, antifungals, dialysis, mechanical ventilation, inhaled Epoprostinol. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown in Jan2021. Pre / post vaccination, the patient has been tested for COVID-19 with unknown result. The with outcome of events was not recovered.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset, the Company considered that there was not a reasonable possibility that the events were related to suspect vaccine BNT162B2. The patient's advanced age, underlying medical conditions and multiple concomitant medications could be contributory to the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
73 2021-02-03 fatigue, fever Chest tightness/heaviness, fatigue, "rubber arms", temp 100.6,
73 2021-02-03 throat pain Client presented for 1st dose Pfizer Covid vaccination. 45 minutes after receiving vaccination clien... Read more
Client presented for 1st dose Pfizer Covid vaccination. 45 minutes after receiving vaccination client complained of Intermittent chest pain in Left Upper Chest. Pulse regular, strong rate of 68. Resp 20, regular. BP138/90. 911 called. Pt now complaint of jaw pain on left side and throat soreness. Client was pale with no sweating. Fidgeting in seat. At 10:48 am EMS arrived. Client immediately transported to Hospital.
73 2021-02-03 fever, headache, chills, throat pain FEVER, BODY ACHES, MILD SORE THROAT, NAGGING HEADACHE, NAUSEA, AND CHILLS
73 2021-02-03 malaise Light headed; lack of appetite; achy; nauseous; sick feeling; This is a spontaneous report from a co... Read more
Light headed; lack of appetite; achy; nauseous; sick feeling; This is a spontaneous report from a contactable consumer (Patient). A 73-Year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EH9899), via an unspecified route of administration at Arm Right on 07Jan2021 10:30 at the 73 years old at single dose for COVID-19 immunization. The medical history was none. The concomitant medications were vitamin C (ascorbic acid), atorvastatin (strength 5 mg), valsartan (strength 80 mg). There was no other vaccine in four weeks. On15Jan2021 08:00 the patient experienced Light headed, lack of appetite, achy, nauseous, sick feeling. The events were continuing though lighter for at least another 3 days. There was no treatment received for all the adverse events. The patient had no Covid prior vaccination. There was covid tested post vaccination. The patient underwent lab tests and procedures, which included Nasal Swab negative on 18Jan2021. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
73 2021-02-03 fatigue, headache PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADA... Read more
PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADACHE, AND NAUSEA FOR 24 HOURS.
73 2021-02-03 malaise Patient's primary care provider received a death certificate to be signed for this patient. He spoke... Read more
Patient's primary care provider received a death certificate to be signed for this patient. He spoke with the patient's husband and son, who reported that the patient had pain and swelling at the vaccine administration site after receiving the vaccine and was feeling unwell after receiving the vaccine. The patient's family reported that they found her unresponsive on 2/2/21 and called 9-1-1. The patient was pronounced dead upon arrival of emergency responders.
73 2021-02-03 influenza like illness, headache, chills flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ... Read more
flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ache; changes from her lower extremities freezing and sometimes it was her whole body; changes from her lower extremities freezing and sometimes it was her whole body; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 at a single dose for covid-19 prophylaxis; apixaban, oral from an unspecified date and ongoing at 5 mg, twice daily as blood thinner medication and atrial fibrillation. Medical history was not reported. Concomitant medication included ongoing dronedarone hydrochloride (MULTAQ) for blood pressure and heart beat, ongoing pravastatin for cholesterol, and dronedarone for blood pressure. For the past couple of days, she had had flu like symptoms. She has had a headache, body aches and chills. It changes from her lower extremities freezing and sometimes it was her whole body. Patient also had a pain in arm. Her left arm was bruised - still black and blue. All of these occurred on 13Jan2021. She did not have a fever. Today (20Jan2021), she was ok. When they went through the check in they asked if patient was on a blood thinner and she was. The patient's husband was wondering if the reactions had anything to do with the vaccine and if the blood thinner medication (Apixaban) she was taking would have caused the bruise. The patient was supposed to get the second vaccine 02Feb2021. Reporter was asking if it is ok to get the second dose. The action taken in response to the event for apixaban was unknown. Outcome of event chills was recovered on 19Jan2021, after 6 days; events flu like symptoms and lower extremities freezing and sometimes it was her whole body was unknown while recovering for other events.
73 2021-02-03 nasal congestion, headache nasal congestion; headache; This is a spontaneous report from a contactable consumer (patient). This... Read more
nasal congestion; headache; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiry date unknown), via an unspecified route of administration on 16Jan2021 20:15 at a single dose on the right arm for COVID-19 immunization. Medical history included high blood pressure, NTM lung infection, and laryngopharyngeal reflux (LPR). Concomitant medications included amlodipine, HCTZ, potassium bicarbonate, sodium alginate (GAVISCON ADVANCE), and telmisartan. The patient has no known allergies. Patient is not pregnant. The patient did not receive other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. On 18Jan2021, the patient experienced nasal congestion and headache. No treatment was received. Outcome of the events was recovering.
73 2021-02-03 fever, chills, cough, fatigue, headache the thermometer that marked 100°F orally (she says that the fever was higher in the night); States ... Read more
the thermometer that marked 100°F orally (she says that the fever was higher in the night); States she is shrinking. Weight varies; cough; 86 of oxygen saturation/O2 saturation was anywhere between 86-88; pulse was 133/rapid pulse, it was 133/rapid heartbeat; her breathing was above 94; shooting pain/stabbing pain at the injection site/extremely excruciating stabbing pains in her arm with the shot; shivers; headache/splitting headache; freezing; slight breathing difficulty; slight body aches; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), via an unspecified route of administration on 15Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included high blood pressure diagnosed 15 years ago, maybe; High cholesterol diagnosed 20 years ago, she doesn't know, reflux diagnosed 20 years ago, maybe more, prediabetes and allergy induced asthma which she carries an inhaler, and she has used it maybe three times a year. Patient reported that she was tested and they don't know for sure, but she reported that she may have allergy induced asthma as she has to take, carries an inhaler, and she has used it maybe three times a year, in the fall when leaves are falling down, the leaves get moldy, and she was driving in her car, or walking in a wooded area, she gets tightness, takes her inhaler and was fine, that's the extent, no other circumstances; fall or she had where a plant was blooming outdoors, she gets tightness, and she took her inhaler, and was good for the next year, so sitting in the environment and nothing further materializes, if she takes the inhaler three or two times a year, considering what other people have, she thought this was insignificant. There were no concomitant medications. The patient reported that she got vaccinated this Friday and had nothing but a sore arm afterwards, on 16Jan2021 and was fine all day, evening, all day Saturday. She just had soreness at the site, she had no redness at the site of injection, but the weird part: she doesn't think anyone would believe, 33 hours later, at midnight, she was still up, on her way to bed, and all of a sudden she experienced extremely excruciating stabbing pains in her arm with the shot, it was stabbing, excruciating, and immediately at the same time, she had shivers/shivered and had a splitting headache, was freezing and had to put socks on, and had noticed very slight difficulty breathing, and since it was midnight, she didn't want to wake up her husband, she dozed off, and was up at 0530. She had body aches, slight, it was the least, but the stabbing stopped in her arm. She slept from 12:30 to 05:30, and the shivering and aches stopped, but the headache was still on, so she took a pill for the headache. She took the thermometer that marked 100F orally; she stated that the fever was higher in the night and she assumed with the shivering, she had a greater fever than 100. Also, the oximeter indicated 133 pulse and 86 of oxygen saturation. By 10:00, it all had resolved. She has an oximeter, and since she still had the feeling of difficulty breathing, she put it on, but her pulse was 133, that was when she was feeling better. It was reported that all symptoms were gone except for rapid pulse, it was 133 and the slight breathing, and her 02 saturation was anywhere between 86-88, it varied, and by 10:00, all issues resolved, her heartbeat was down to normal, her breathing was above 94, or whatever, everything was fine, and has been fine since then. Maybe she had fatigue on Saturday and Sunday, on Sunday was like after the flu, after you finish, you have fatigue and was a little out of it, this was on Sunday. On an unspecified date, the patient stated that she was shrinking and weight varies. Patient stated that the only thing she does have, says she has a cough, but because she needs a drink, she was not sick and she gets to drink water. She felt like the reaction she had was in the limit of a severe allergic reaction due to the rapid heartbeat and her difficulty breathing. She would like to know if there was information about these side effects reported so she can determine if she was going to have the second dose of the vaccine. Outcome of events states she was shrinking, weight varies and cough was unknown; and outcome of the rest of events was recovered on an unspecified date.
73 2021-02-04 headache, body temperature increased Headache A severe feeling of burning on my facial skin and a flushing of the skin My forehead felt... Read more
Headache A severe feeling of burning on my facial skin and a flushing of the skin My forehead felt as though I had a severe sunburn A slightly elevated temperature: normal is 97.3 elevated 98.6 All day 02/01, Partial day 02/02, Redness gone and feeling of burning less severe 02/03 and 02/04. 02/05 a couple of episodes of sensation of facial burning and slightly elevated temp
73 2021-02-04 fatigue tired; mildly sore arm; This is a spontaneous report from a contactable nurse (patient). The 73-year... Read more
tired; mildly sore arm; This is a spontaneous report from a contactable nurse (patient). The 73-years-old female patient received bnt162b2 (BNT162B2, lot number: EL3302, Expiry Date: 31May2021) via an unspecified route of administration in Left arm on 21Jan2021 10:45 at SINGLE DOSE to gain immunity against Covid-19. Medical history included asthma well controlled Diagnosed 6 years ago. No Prior Vaccinations within 4 weeks. There were no concomitant medications. The patient experienced mildly sore arm on 21Jan2021, tired on an unspecified date. The AEs did not require a visit to emergency room or physician office. The outcome of the event mildly sore arm was recovering. No follow-up attempts possible. No further information expected.
73 2021-02-05 headache, fever, chills Temperature 101.3, severe headache, chills, fever, diarrhea, body aches, unable to move left arm, hi... Read more
Temperature 101.3, severe headache, chills, fever, diarrhea, body aches, unable to move left arm, high heart rate, difficulty breathing
73 2021-02-06 throat irritation, cough Persistent Swollen tight uncomfortable throat, initially a burning sensation ~ 12 hours, difficulty... Read more
Persistent Swollen tight uncomfortable throat, initially a burning sensation ~ 12 hours, difficulty swallowing cleocin cap and foods, dry cough This is my second day with symptoms
73 2021-02-07 headache Pt states they felt eyelids hot and felt a heachache. Pt stayed for additional monitoring. Pt denie... Read more
Pt states they felt eyelids hot and felt a heachache. Pt stayed for additional monitoring. Pt denies any other c/o. Pt aloc x 4. Resp. unlabored and even. Pt later states her eyelids feel normal and headache went away. Pt d/c home.
73 2021-02-09 sweating, chills, body temperature increased 12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgi... Read more
12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgias. Symptoms lasted 48 hours. Over last 24 hours patient has developed redness and itching over the injection site on the right arm.
73 2021-02-09 fever, malaise feeling very dizzy; Very sick feeling; low grade fever; Vertigo; My head does not feel like it's att... Read more
feeling very dizzy; Very sick feeling; low grade fever; Vertigo; My head does not feel like it's attached to my body; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 12:30 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 73 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included heart stent. The patient has no known allergies. Concomitant medications included lisinopril, clopidogrel besylate (CLOPIDOGREL), metoprolol, rosuvastatin. On 21Jan2021 16:00 the patient started feeling very dizzy, vertigo, she stated: 'It's two days now I still feel it, very sick feeling, had a low grade fever, my head does not feel like it's attached to my body'. No treatment was given for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. Information about Batch/Lot number has been requested.
73 2021-02-14 headache Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood press... Read more
Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood pressure 193/94; shakiness; This is a spontaneous report from a contactable consumer (patient) reported for that a 73-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) , via an unspecified route of administration on 30Jan2021 14:30 at single dose at right arm for covid-19 immunisation. Medical history included blood pressure. Concomitant medication included pantoprazole, metoprolol, atorvastatin, metformin. The patient previously took Cefdinir and experienced allergy. The patient experienced dizziness with very high blood pressure 193/94, also shakiness, major headache on 30Jan2021 16:30. Adverse event result doctor or other healthcare professional office/clinic visit. The patient had EKG. Therapeutic measures were taken as a result of events included unspecified medication. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
73 2021-02-16 fatigue Pt had onset of weakness in lower legs and forearms immediately following the vaccine and is very fa... Read more
Pt had onset of weakness in lower legs and forearms immediately following the vaccine and is very fatigued since receiving the vaccine.
73 2021-02-16 productive cough Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joi... Read more
Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joint and muscular aches. Then progressed to persistent productive cough. No fever during this time. These symptoms lasted until 2/15/2021.
73 2021-02-17 sweating At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely d... Read more
At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered. The information on the batch number has been requested.
73 2021-02-17 fever almost comatose/couldn't get a response; really really hot/took her temperature it was 101.8/fever; ... Read more
almost comatose/couldn't get a response; really really hot/took her temperature it was 101.8/fever; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported for two patients. This is the first of two reports. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318 and expiration date 31May2021), via an unspecified route of administration in the right arm on 02Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Type 1 diabetic; Alzheimers from 2014 and ongoing, about 7 years ago; and covid-19 from Dec2020 to Dec2020. There were no concomitant medications. At 4 am yesterday morning (03Feb2021), she developed side effects. The patient's husband woke up at 4 am and touched the patient to make sure she was okay like he does every night. When he did, patient was really really hot. He took her temperature it was 101.8. She was almost comatose, and he couldn't get a response from her. He gave her fluid with a straw on her lips. At 7:30 am, 3.5 hours later, she was still hot. He was putting cold compresses on her. He called the hospice nurse, and she came and checked her vitals. She had a fever of 101.5 that time. He continued cold compresses. Her vitals were stable. Then about afternoon, her fever broke, and she became coherent. The rest of yesterday, and today she seems to be fine. She had a side effect that caused her to have a fever and be out of it. He couldn't get a response from her until noon yesterday. When the fever broke around noon, that is when she became more responsive and back to normal. Outcome of the events was recovered on 03Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156644 same reporter/drug, different patient/event
73 2021-02-21 fatigue Fatigue and brain fog, or dullness from Tuesday 02/09/2021 through Friday 02/12/2021.
73 2021-02-21 sleepiness I was extremely sleepy. I went to sleep Saturday night, got up at 8 am. At 9:30 am I was so sleepy... Read more
I was extremely sleepy. I went to sleep Saturday night, got up at 8 am. At 9:30 am I was so sleepy I could hardly walk. I went to bed and slept for 7 hours without waking up. When I got up I felt better.
73 2021-02-21 malaise Pfizer-BioNTech COVID 19Vaccine EUA Fever of 99 degrees, slept for 32+ hours followed by aches for 1... Read more
Pfizer-BioNTech COVID 19Vaccine EUA Fever of 99 degrees, slept for 32+ hours followed by aches for 12 hours. General malaise,
73 2021-02-21 chills, headache, sweating This is not a critical reaction but want to report in order to help build up the information availab... Read more
This is not a critical reaction but want to report in order to help build up the information available to healthcare professionals going forward. Morning after chills, neck stiffness, pain back of head left side. Applied heating pad to neck. By late morning I was nauseous , and weak as a kitten. Took a 500 mg Tylenol and slept for about 4 hours. Woke up in a sweat but chills gone and am now able to eat a little bit. Back of head and neck still very sore. The injection site is sore but no rash; right arm seems to have "phantom pain" as well ( I experienced this with Shingles shot in December 2020 too).
73 2021-02-21 fatigue, headache Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 1... Read more
Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 18 hours. Had to use heating pad and massage to help feet relax from en pointe position so I could walk to the bathroom. Legs were sore after 18 hours but not cramped . Also massive headache made my eyes light sensitive all day Saturday and Sunday until about 9PM. Extreme exhaustion. Recovering today, Monday. Still tired an s slight residual headache at times but not bad enough for painkiller.
73 2021-02-21 fever, chills fever, chills, swollen lymph nodes in armpit under site of injection, which disappeared after 10 day... Read more
fever, chills, swollen lymph nodes in armpit under site of injection, which disappeared after 10 days. Metal smell and taste which lingers.
73 2021-02-22 cough, malaise, fever FEVER 100 COUGH ACHING MALAISE
73 2021-02-22 dehydration I had passed out hitting a table bumped head and back.; very dry mouth; felt very light headed; Thou... Read more
I had passed out hitting a table bumped head and back.; very dry mouth; felt very light headed; Thought maybe I may have been dehydrated; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at Left arm on 06Feb2021 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included High blood pressure. Concomitant medications included losartan, atorvastatin calcium (LIPITOR) and vitamins. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up 1:30 am 07Feb2021very dry mouth, used restroom, felt very lightheaded, went back to room, next thing she heard was glass breaking. She had passed out hitting a table bumped head and back. Her boyfriend was with she helped she up. Said her legs went out from under her. Thought maybe she may have been dehydrated though she had drunk water throughout the day and before bedtime. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Feb2021.
73 2021-02-22 body temperature increased Red inflamed 5" x 2" hot reaction at injection site. No pain itching or swelling. Temperature of ~10... Read more
Red inflamed 5" x 2" hot reaction at injection site. No pain itching or swelling. Temperature of ~100 F
73 2021-02-22 fatigue, chills Symptoms occurred about a week after the first AND the second covid vaccination. Lot number of fir... Read more
Symptoms occurred about a week after the first AND the second covid vaccination. Lot number of first is EI9262 and of second (as above) EN6201. In addition to expected fatigue and chills (I experienced no sore arm or fever) I developed symptoms of gallbladder attack with extreme abdominal pain and vomiting. These lasted for just over 2 days.
73 2021-02-23 headache, chills 2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: sev... Read more
2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: severe abdominal pain; low backahe; headache--aleve and rizatriptan 2/21/2020 through 2/25/2020 severe stiff neck; headache; aleve X4 pills Only a sore arm from the fist vaccine.
73 2021-02-23 headache About 20 minutes after vaccine, the right side of my face (including nose, some of my tongue) felt n... Read more
About 20 minutes after vaccine, the right side of my face (including nose, some of my tongue) felt numb or tingly. Very mild. Symptoms disappeared within, say, a half hour and did not return. The following morning I had fleeting head aches on right side - each lasting a' second or so only, and several hours apart. By the afternoon they disappeared. I am having no other symptoms. My arm never hurt at the injection site. I'm not even concerned but feel I should mention this reaction because I will be getting a second shot on March 16. Is it safe? Again, I have no symptoms any longer and feel great.
73 2021-02-23 malaise, fever Feeling sick, AFIB occurrences, had a fever on 2nd day of 100.8, left shoulder hurt from shot and ju... Read more
Feeling sick, AFIB occurrences, had a fever on 2nd day of 100.8, left shoulder hurt from shot and just felt very bad all over!
73 2021-02-23 fever, chills Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and contin... Read more
Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and continued upset stomach. Sunday night slight cramping in stomach. Monday AM Full blown cramping , afternoon 99.2 fever, chills, hands cold continued severe cramping. Took Tylenol. Tuesday slight cramping from stomach to rectum, normal temp. Wednesday slight cramping comes and goes. Feeling much better.
73 2021-02-24 chills Bad shaking chills, my whole body was shaking started almost exactly 24 hrs after 2nd dose Shaking ... Read more
Bad shaking chills, my whole body was shaking started almost exactly 24 hrs after 2nd dose Shaking lasted about 20 minutes and I continued feeling chilled till bedtime
73 2021-02-24 headache, malaise COPD on 2L BL O2 requirement, hypothyroidism, cachexia, GERD with similar presentation earlier this ... Read more
COPD on 2L BL O2 requirement, hypothyroidism, cachexia, GERD with similar presentation earlier this month post-covid vaccine # 1, who presetned for feeling sick and SOB. Patient received her second dose of the covid vaccine on 2/19/21, 3 days prior to presentation. The following day, she started having "breathing issues" so she was given a dose of prednisone. 1 day prior to presentation, her breathing had improved but she was feeling generally sick, so she was given tylenol but not pred. Then, today, day of admission, patient was having bodyaches, weakness, headache, and breathing issues again. She took prednisone this morning, but still had to turn up her O2 because her work of breathing kept fluctuating. Admitted 2/22/21 ? 2/24/21.
73 2021-02-24 malaise, fever, chills, influenza like illness On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, ch... Read more
On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, chills, ear ache, pain level 8. Felt sick all over, like having the flu and then whole body ached, not just GI track. Left arm injection site was red, sore to touch, swollen (slightly). Doctor couldn't get vaccination needle into arm muscle the first time and so had to try a second time. Intense cramping of GI track started up again 8:45AM on Feb. 13th. By 4PM Feb. 15th fever 102F, chills, felt freezing cold and had to wrap myself in a heating blanket. Pain level 10, especially in pancreas. Fever broke around 2:30AM Feb. 16th and later when I was up at 8AM I felt very weak, faint, pancreas ached. Pancreatic pain lasted another 3 days. Pancreatic pain stayed around level 5. On Feb. 17th took ibuprophen. Pain level reduced to 1. This was the only time that I took pain medication between Feb. 10th and 17th, because I am conservative about using Ibuprophen, Tylenol, and have a high threshold for pain.
73 2021-02-24 chills, fever, fatigue Started with chills for about 1 hour then fever (about 100.4) and tired. It was now in the middle ... Read more
Started with chills for about 1 hour then fever (about 100.4) and tired. It was now in the middle of night when chills ended then I was very restless. It lasted about 24 hours then I felt fine - no fever.
73 2021-02-24 fatigue, headache Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely t... Read more
Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely tired and sore arm that day. Day 2 - tired easily, no stamina. Dizzy and nauseous after showering at3:30 pm. By 10:30, both hands were red and itched. Sometime in the night woke with a very sharp, painful headache. Did not last. No real problem again until Saturday. Nausea at 11:20 am. Sunday I sat all day doing taxes - no symptoms noted. Monday after walking - rapid heart rate and very tired after what is normal activity. By 4:30 I was tingling all over my body. Tuesday night my ankles are swollen for the first time in years. Only happened that nigh. Wednesday morning, the tingling is very strong in my calves. and I had a sharp pain in the area of my Achilles tendon. I believe that the vaccine has exacerbated the neuropathy (undiagnosed) of the bottom of my feet. Today I am reporting because I fell for no reason getting out of a chair, and the tingling is in my legs, arms, shoulders. I had not heard until today that the vaccine could affect the nervous system. The effects are the worst they have been and it has been one week since I had the vaccine. Should I get the second shot? Due March 11,2021.
73 2021-02-25 chills, headache Chills, Body aches, Headache
73 2021-02-25 fever, lethargy, headache Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This ... Read more
Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.
73 2021-02-25 fatigue Patient was tired and slept for two days after vaccine. Then had nausea and general "blah" feeling ... Read more
Patient was tired and slept for two days after vaccine. Then had nausea and general "blah" feeling for the next 2 1/2 weeks and had nose bleeds. On Day 4 she did vomit. After second shot, she complained of constipation and aching on over. She vomited twice.
73 2021-02-25 headache Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain an... Read more
Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain and inability to support my weight, this lasted for three days with 2nd day being the worst pain and discomfort. Also had a headache for most of the day on the second day. Four days following vaccine I started to notice the injection site was getting itchy, then on day Five it was increasing and started getting red, swollen, hot and itch increased. Day Six it is still itchy, red, hot and swollen. Red site is about the size of an orange. As of Day Six, No fever, headache or other symptoms and knee has returned to normal discomfort.
73 2021-02-25 headache headachy urination decreased
73 2021-02-25 fatigue, sweating, fever, chills ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching i... Read more
ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching in her shoulder, into her back; aching in her shoulder, into her back; weak and unable to function; weak and unable to function; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), intramuscular on 16Jan2021 1:45 PM at a single dose on the left shoulder, right at the very top for COVID-19 immunization. Medical history included ongoing lupus since 1999. Concomitant medications reported were none. The patient experienced aching in her shoulder, into her back, dizziness, she was not quite herself on 16Jan2021; she ran a fever of 101 degrees, had lots of chills and sweating on 18Jan2021; she became weak and unable to function, and tired on an unspecified date in Jan2021. The patient stated she got the first dosage of the COVID-19 vaccine and had some side effects. She received the first COVID-19 vaccine on 16Jan2021. She had some aching in her shoulder and stuff on 16Jan2021. For 2 days, she was weak and unable to function. She ran a fever of 101 degrees on 18Jan2021 and was sweating head to toe. At the time of report, she currently had no fever, but was feeling very fatigued. She stated she is trying to make her next appointment, but she can't pull up the paperwork. She wants to know what to do about the side effects. Her next appointment on 13Feb2021. Her shoulder hurt an hour after she received the vaccine on 16Jan2021. That night and the next day, the whole shoulder even into her back started hurting. Like when she rolled over and laid down, she would say "ohhh, I can't lay that way". This lasted for a couple of days. Her shoulder is still tender, but it is much better. She can lift it up, move it around and it's not causing her any difficulty. She stated she became weak. The first night after receiving the vaccine in the middle of the night, she kind of had like a dizziness, she was not quite herself. She thought it was just part of the vaccine. The next day, she couldn't do anything. She was down for 2 days after that. On the 17Jan2021 and 18Jan2021, she was feeling really happy. On 18Jan2021, she started to have a fever. She had a fever that night and part of the next day. She had lots of chills. The fever and chills have seemed to go away. She just feels really fatigued after. She woke up twice and her whole body was soaked. She states that is all gone now. She has had no fever. She had a very good night last night. She stated her aches and pains were at a minimal. She stated she is 73 years old, so she is going to have aches and pains as it is. At the time of the report, all she has is fatigue. She added that the fatigue isn't coming from her, it's from the vaccine. She was very active usually. But at the time of the call, she would get up to do a little and then she would have to sit back down. She was very tired. She was feeling weak and out of pocket. She was so tired. She didn't want to do anything. She stated she must find someone who can print her new paperwork. She plans to call her doctor and see what he thinks about her receiving the second shot. She feels she really needs to get the second shot. During the report, she made the comment "I'm sorry, I'm choking on my cough". The patient underwent COVID-19 test on 14Jan2021 with result of negative. She also underwent blood test on an unspecified date with unknown results. The reported adverse events did not require a visit to the physician office or emergency room. Outcome of the event fatigue was not recovered, while outcome of the other events was recovered on an unspecified date in Jan2021. Information on the Lot/Batch number has been requested.
73 2021-02-26 headache, sleepiness Extremely mild: headache, site injection soreness. Mild: difficulty breathing - required oxygen & ... Read more
Extremely mild: headache, site injection soreness. Mild: difficulty breathing - required oxygen & sleepiness. Also, antagonized my dry eye problem - requiring drops every couple of hours round the clock instead of just twice a day.
73 2021-02-26 headache, fatigue Fatigue, shortness of breath, digestive issue, headache. Symptoms took 10 days to mostly go away. ... Read more
Fatigue, shortness of breath, digestive issue, headache. Symptoms took 10 days to mostly go away. Still have shortness of breath. Took Tylenol and got lots of sleep.
73 2021-02-26 fatigue, fever, headache Low grade fever, headache, fatigue , arm pain and heat.
73 2021-02-26 headache, chills, body temperature increased, fatigue Slightly elevated temp, mild nausea, chills, muscle aches, fatigue, mild headache. All this started ... Read more
Slightly elevated temp, mild nausea, chills, muscle aches, fatigue, mild headache. All this started 6 days after the vaccine. On the 6th night after the shot, symptoms lasted about 8 hours. Then started up worse during the night of the 7th day, especially the chills, elevated temp, fatigue and nausea. Symptoms such as the chills are starting to subside about 10 hours later but some such as mild fatigue still remain. Is this normal for symptoms to show up nearly a week after the shot?
73 2021-02-26 fatigue, runny nose extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no tast... Read more
extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no taste, extreme thirst rash on front of both legs and both arms,night sweats, runny nose
73 2021-02-26 fatigue sore upper left arm 2 days, fatigue 5 days, muscle & joint pain 5 days, diarrhea 4th day rested a... Read more
sore upper left arm 2 days, fatigue 5 days, muscle & joint pain 5 days, diarrhea 4th day rested and slept for fatigue took Tylenol first 2 days, and ibuprofen thereafter for pain took bismuth subsalicylate for diarrhea
73 2021-02-27 fever, headache, chills Fever 102.1 headache chills soreness at injection site
73 2021-02-27 chills, fever Fever, chills, muscular aches, nausea...approx. 14 hrs. after injection...had a "tin" taste immediat... Read more
Fever, chills, muscular aches, nausea...approx. 14 hrs. after injection...had a "tin" taste immediately after the injection, lasting about 15 minutes
73 2021-02-27 chills, fever Sore arm for 24hrs, chills and low grade fever (99.1). 28 hrs
73 2021-02-28 headache, body temperature increased All day.
73 2021-02-28 chills Female patient experiencing chills 30 minutes after Pfizer vaccine administered. No other symptoms r... Read more
Female patient experiencing chills 30 minutes after Pfizer vaccine administered. No other symptoms reported. Vitals 140/90, HR 70, SPO2 100% on room air, Respirations 22, Temp 97.3 axillary. Patient appears anxious but states she is not. Emergency response activated/ 911 called. Benadryl administered via IM on right deltoid. Paramedics arrive at 1054hrs. Takes patient via gurney to further assess in ambulance. Patient is vitally stable. Refused further care. Left AMA.
73 2021-02-28 headache, chills Headache nausea chills weakness severe arm pain right arm . Recovered in 10 hours followed by ... Read more
Headache nausea chills weakness severe arm pain right arm . Recovered in 10 hours followed by slight headache for several days.
73 2021-02-28 fatigue, cough Nausea, diarrhea, rib cage pain so bad I couldn't lie down/sleep, exhaustion, Muscle aches and pain,... Read more
Nausea, diarrhea, rib cage pain so bad I couldn't lie down/sleep, exhaustion, Muscle aches and pain, loss of appetite, cough,
73 2021-02-28 body temperature increased, malaise, headache, chills Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep becaus... Read more
Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep because I was just uncomfortable all over. Felt a little light headed. At 7:00 took temp,99.2,- my normal is around 97.7. Right arm was feverish and extremely sore,more so than first vaccine. All that day fever went up to 101.2 by the afternoon. Drank liquids all day. had a headache most of the day with all over joint pain. Never had the flu but think this must be how you feel. Fever broke around 3:00AM on 2/26. Upper arm remains sore, swollen,red and feverish as of today,3/1
73 2021-02-28 fever has had a fever since this time; her ileostomy had a blockage that day and she vomited all night; he... Read more
has had a fever since this time; her ileostomy had a blockage that day and she vomited all night; her ileostomy had a blockage that day and she vomited all night; it was very severe and sore and she is just getting over the soreness; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1283, first dose) solution for injection intramuscular in left deltoid on 18Jan2021 at 14:20 (at the age of 73-years-old) at single dose for COVID-19 vaccination. Medical history included ongoing type 2 diabetes, ongoing active carcinoid cancer of liver, ongoing Ileostomy from Jul2002, surgery in 2001, second primary colon tumor, acid reflux and neuropathy in feet and legs. Concomitant medications included amlodipine besilate for blood pressure, lisinopril for blood pressure, metformin, sitagliptin phosphate (JANUVIA) and gabapentin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient has had a fever since this time on 18Jan2021 and was very severe and sore and she is just getting over the soreness in Jan2021. Temperature was 102 F on 18Jan2021, 101 F on 19Jan2021, the having a fever in varying degrees like 99 F or 100 F after in Jan2021. On 18Jan2021, her ileostomy had a blockage that day and she vomited all night. Treatment for the event fever included ibuprofen (ADVIL). The outcome of the event fever was not recovered. The outcome of the events vomited and ileostomy had a blockage was unknown. The outcome of the event pain was recovering.
73 2021-02-28 respiratory tract congestion irregular heart beat; congestion in the chest; dizzy/the dizziness she was having and feeling now af... Read more
irregular heart beat; congestion in the chest; dizzy/the dizziness she was having and feeling now after getting the vaccine was definitely more noticeable; This is a spontaneous report from a contactable consumer (the patient). A 73-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left deltoid/ left upper arm in the shoulder on 26Jan2021 around 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: stroke about 4-5 years ago in June, dizziness, blood pressure. The patient also had difficulty writing stuff down; besides having a number issue, she had issues writing numbers down. Concomitant medication included apixaban (ELIQUIS) from an unspecified date and ongoing as a blood thinner. The patient stated she was on ten different medications. These medications were added after the stroke. Before the stroke she was not on any medication. The patient did not have any vaccines administered on same date of the Pfizer COVID vaccine. The patient got the pneumonia vaccine (unspecified), but thinks it was longer than 4 weeks before. She did not remember, but she believed it had been a month and a half to 2 months (at the age of 73-years-old) since getting the pneumonia vaccine for immunization. The patient had the COVID shot on Tuesday of this week (26Jan2021), and she didn't seem to have much of a reaction other than what they expected except at 21:00 that night, she got pretty dizzy. She was still dizzy now. It was enough for her to have to walk with a cane in order to try and keep herself leveled. She could not move quickly. She did not know why she had this reaction. She called her doctor the next day, and he did not understand why. She mentioned she was reading material and saw this could be a severe side effect/situation. The doctor mentioned they were trying to find out if it was related to the blood pressure. She wanted to know if this is part of the side effect, dizziness? When the patient was attempting to provide the zip code, she stated her mind was going blank and could not remember the zip code. She later found something with it written on it and provided those details. She explained she had a stroke when trying to provide her current age. She stated numbers are hard for her. She stated she would be 74 in March, and questioned how old that would make her now, she later confirmed as 73. She read information today about the COVID vaccine, and she saw that one should be cautious about the vaccine if have a bleeding disorder, and she commented she was on a blood thinner. She went to the doctor last week and mentioned she was having dizziness. She clarified she had dizziness before getting the COVID-19 vaccine. When she went to the doctor, they thought it was due to blood pressure as the problem. They changed her blood pressure medication by placing on a higher dose. Then she started having more dizziness, and the dose was taken back down to the dose she was on before. She also added, she has an irregular heartbeat (unspecified date). She went to the doctor because of congestion in the chest (unspecified date); that was why she went to the doctor. The doctor asked about dizziness and she said she was having a little. However, the dizziness she was having and feeling now after getting the vaccine was definitely more noticeable. The clinical outcome of dizzy was recovering (as reported). The outcome of the other events was unknown. Information on Lot/Batch number has been requested.
73 2021-02-28 malaise she's not feeling well; This is a spontaneous report from a contactable consumer (patient's daughter... Read more
she's not feeling well; This is a spontaneous report from a contactable consumer (patient's daughter-in-law) via the Pfizer-sponsored program. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021, at single dose, for covid-19 immunization. Medical history included covid-19 - the patient has been tested positive on an unspecified date but it's 2 months now, and they said that it's still in her. Concomitant medications were not reported. The patient had the first shot yesterday 26Jan2021 and she's not feeling well on Jan2021. The outcome of the event was unknown. Information on the lot/ batch number has been requested.
73 2021-03-01 chills, fever Chills and fever began at approx. 1:30 a.m. on February 27. Continued until late mid-day on March 1... Read more
Chills and fever began at approx. 1:30 a.m. on February 27. Continued until late mid-day on March 1. Extreme weakness and nausea. Had no appetite. Very dry mouth. Fever lessened by evening of March 1. Weakness and feeling of lightheadedness continuing as of today, March 2, morning. No more nausea today. No fever today Able to eat small amount of food
73 2021-03-02 headache severe cramps; mild headache; lower abdominal pain across lower abdomen; This is a spontaneous repor... Read more
severe cramps; mild headache; lower abdominal pain across lower abdomen; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), on 15Feb2021 at 09:30 AM (at the age of 73-year-old) on left arm at single dose for COVID-19 immunization. It was reported that patient was not pregnant at the time of event and at the time of vaccination. The patient's medical history was reported as none including no known allergies and no covid prior vaccination. The patient's concomitant medications included simvastatin (ZOCOR). The patient previously received the first dose of BNT162B2 (lot number EL1283), on 25Jan2021 09:30 AM (at the age of 73-year-old) on left arm for COVID-19 immunization, no other vaccines were administered in four weeks prior to vaccination. On 16Feb2021 at 10:00 AM the patient experienced mild headache severe cramps and lower abdominal pain across lower abdomen. The event "severe cramps" was reported as serious with criteria medically significant while the other events were reported as non-serious. No treatment for the events was received. No covid test was performed post vaccination. The outcome of the events was not resolved.
73 2021-03-03 chills, fever Around 3 PM on 3/2 arm was extremely sore and became worse as time progressed. By 6 PM developed... Read more
Around 3 PM on 3/2 arm was extremely sore and became worse as time progressed. By 6 PM developed aches, chills and low grade temperature. Became lightheaded. Could not sleep due to symptoms. No appetite but drank herbal tea and water with added electrolytes. That severity of symptoms lasted until 3/4 at 6 AM. Still am having some residual effects as one might have with the flu ? fatigue etc. Temperature is gone no more chills appetite still diminished.
73 2021-03-03 fatigue, fever Fever of 101, severe body aches, fatigue
73 2021-03-03 fever, headache Heart skipping and racing for apx. 2 hours after vaccination. Headache Low grade fever Body ac... Read more
Heart skipping and racing for apx. 2 hours after vaccination. Headache Low grade fever Body aches. Pain in all bone including ankles, fingers, and toes and arches
73 2021-03-03 fatigue Overwhelming tiredness for 2 days Fatigue- Slept all through nights A little foggy mind Redness and... Read more
Overwhelming tiredness for 2 days Fatigue- Slept all through nights A little foggy mind Redness and swelling around site of injection- still demonstrating on third day March 4
73 2021-03-03 headache She has immune issues and stress/ methylprednisolone for immune issues; She has immune issues and st... Read more
She has immune issues and stress/ methylprednisolone for immune issues; She has immune issues and stress/ methylprednisolone for immune issues; severe headache/ pain in the base of her skull; nausea; vomiting; had pain at the top of her spine where the spine meets the skull; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (BNT162B2, lot number: EL9264) via an unspecified route of administration, on 01Feb2021 12:45PM at a single dose on top of left arm for COVID-19 immunization. The vaccine was given at a Clinic which is an off shoot of the hospital. The patient did not receive any vaccinations within 4 weeks prior to receiving BNT162B2. Medical history included Wegner's disease, immune issues and stress. She stated that there would be one doctor providing medication for stress and other doctor providing other medications. She has immune issues and stress. Concomitant medications included buspirone from an unspecified date and ongoing (been on it for quite a few years), clonazepam from an unspecified date and ongoing (been on it for quite a few years), fluticasone propionate (FLOVENT) from an unspecified date and ongoing (been on it a little over a year or two and it was prescribed by her pulmonologist), hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) from an unspecified date and ongoing (has been on it for more than 5 years and was prescribed by her primary care), methylprednisolone for immune issues, bupropion hydrochloride (WELLBUTRIN), and nebulizer for saline for Wegner's disease (It is prescribed by her ear, nose, and throat doctor). The patient previously received a flu shot in 2020 and experienced sore arm and achy feeling. On 01Feb2021 18:45, the patient experienced severe headache, nausea, vomiting, and pain in the base of her skull. A lot of people thought it was throwing her into a migraine. She has never had a migraine in her life. It was awful and pretty extreme. Severe headache, nausea, vomiting, and pain in the base of her skull started about six hours after the shot (at 18:45) and proceed a good 24 hours later. She also had pain at the top of her spine where the spine meets the skull. She would say that the symptoms stopped on 02Feb2021. She has recovered almost completely. She is still not quite completely 100 percent. The reported adverse events did not require a visit to emergency room or physician office. Some relatives said she should have gone in, but she did not. Outcome of the events was recovered on 02Feb2021.
73 2021-03-03 chills, body temperature increased Temp of 100 degrees, muscle aches, chills lasted about 24 hours. Following day three episodes of dia... Read more
Temp of 100 degrees, muscle aches, chills lasted about 24 hours. Following day three episodes of diarrhea
73 2021-03-03 malaise, chills, fatigue, headache, nasopharyngitis food poisoning; First got really sick; nausea/She got sick to her stomach; head colds/feels like com... Read more
food poisoning; First got really sick; nausea/She got sick to her stomach; head colds/feels like coming down with a cold; Feeling unwell/she wasn't feeling well; Dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever.; sinus problems.; vomiting; Pain injection site; Slight headache; Chills, feels like coming down with a cold; Tired; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: RL3249), via an unspecified route of administration at left arm on 26Jan2021 14:00 (also reported as 17Jan2021 - pending clarification) at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included diabetes, cancer (prior to receiving COVID-19 shot. Stated she was 14 years cancer free), allergy, shingles shot which hurt at the injection site, shrinks every year (Doesn't know exact number, but a little under 5 feet). The patient had no family medical history. Concomitant medication included mometasone furoate (FLONASE [MOMETASONE FUROATE]). On an unspecified date, the patient experienced she got sick to her stomach, food poisoning, "nausea/She got sick to her stomach," "head colds/feels like coming down with a cold," "feeling unwell/she wasn't feeling well," "dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever," sinus problems, vomiting, and first got really sick. On 26Jan2021, the patient experienced tired, slight headache, chills feels like coming down with a cold, and pain injection site. The patient reported that she received the first dose of the Pfizer vaccine and experienced side effects including nausea, head colds, and sinus problems. She was concerned that this may be covid and if it will be safe for her to get the second dose of the vaccine as scheduled. The patient further reported that she first got really sick. Never had the flu and always gets head colds or food poisoning on an unspecified date. After reading material passed out, perhaps she was treating COVID and not a cold or allergy. The patient took first COVID-19 shot on 26Jan2021. Thought everything was fine. The patient was close to bedtime then noticed she wasn't feeling well. Looked at side effects and has like six of them at the same time. Right as she was going to rest, she got sick to her stomach. Never was sick to her stomach except when she was food poisoned. The patient had dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever on an unspecified date. The patient asked that if she does have COVID, should she take the second shot? Wanted to get tested because Pfizer materials says exactly what her headache and sinus stuff was about. Now she was scared. The patient also reported that she wanted to take the second COVID-19 shot. If she does have COVID, thinks it's not the thing to do right now. It was confirmed she has not had a positive COVID test after receiving the first COVID-19 shot. Should have read material prior to and maybe wouldn't have taken the first COVID-19 shot. Confirmed symptoms she mentioned occurred after the COVID-19 shot. The patient came home from COVID-19 shot feeling fine. Didn't get sick until close to bedtime. Appointment for COVID-19 shot was 2:30PM. Clarified six symptoms previously mentioned: The patient had pain at injection site just two days and was gone. Began shortly after she got home from the COVID-19 shot. Went to lift arm up and it didn't feel good. Began an hour or two after COVID-19 shot. The patient was tired unusually early in the day. Felt like she didn't want to do anything. Couldn't use her left arm. Clarified left arm was injection arm. Tiredness has subsided and only lasted a couple of days. It was further reported that patient never gets headaches. It started after vomiting which didn't last long. It bothered her and then was gone by the time she went to sleep. The patient had chills, feels like coming down with a cold on an unspecified date which subsided right before dinner around 3PM-4PM. The patient had to put on a fluffy robe to keep warm. It was also reported that the patient did not have a fever. It was also reported that shingles shot hurt at injection site where pain lasted a week and a half. Temperature went from 98.6 degrees to 99 degrees. The patient was taking stuff now and monitoring to see if she can see any signs. The patient was feeling unwell on an unspecified date which has subsided except for allergies and she was concerned. The patient also experienced dry heaving: didn't have anything in her stomach on an unspecified date which subsided. Even after she ate yesterday, hasn't had any dry heaving except for night of the COVID-19 shot. The patient underwent lab tests and procedure which included body height: little under 5 feet (doesn't know exact number), temperature: went from 98.6 degrees to 99 degrees, and COVID test: negative (she has not had a positive COVID test after receiving the first COVID-19 shot). Therapeutic measures were taken as a result of sinus disorder which included sinus medication and was squirting Flonase in her nose. On an unspecified date, the patient recovered from slight headache. The patient had not yet recovered from the event nausea and vomiting. The outcome of the events chills, tired, food poisoning, first got really sick, head colds/feels like coming down with a cold, feeling unwell/she wasn't feeling well, dry heaves, sinus problems, and pain injection site were unknown.
73 2021-03-04 headache March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symp... Read more
March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symptoms that had been in remission were now present. no strength in left injection arm, all muscles weakened. slight headache. All subsided about ten pm.
73 2021-03-04 headache Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulde... Read more
Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulder, arm to palm, thumb and finger tips. Muscular pain from neck (felt like pinched nerve) thru shoulder to wrist (felt like carpel tunnel). Blooming painful pustule rash from shoulder to wrist on inner arm for one week. Post-herpetic and muscular pain continues through rash scabbing and drying, to date March 6, 2021. This is my second event in 37 years.
73 2021-03-04 fever tenderness at injection site, low grade fever, aching in all joints-started at 12:30-7;30 3/5/21, 3 ... Read more
tenderness at injection site, low grade fever, aching in all joints-started at 12:30-7;30 3/5/21, 3 doses of advil,vomiting
73 2021-03-07 fatigue 48hours and still have fatigue and joint pain; 48hours and still have fatigue and joint pain; This i... Read more
48hours and still have fatigue and joint pain; 48hours and still have fatigue and joint pain; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on the left arm on 28Jan2021 at 09:00 AM at a single dose for COVID-19 immunisation. The patient medical history was none. There were no allergies to medications, food, or other products. Concomitant medications included rosuvastatin calcium (CRESTOR) at 5mg, vitamin D and zinc. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced fatigue and joint pain on 28Jan2021 at 14:00 and after 48 hours also, was experiencing the events. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
73 2021-03-08 malaise, fever, influenza like illness, sweating, headache, fatigue, chills Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the in... Read more
Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the injection; I have a slight fever of a 100; I feel I am cold, I have the chills; Headache; joint pain; muscle pain unbelievable; nauseous; I was sick all day; symptoms felt like when you are getting the flu and when you get the flu vaccine; tiredness; sweating; This is a spontaneous report from a contactable consumer, the patient. This 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 05Feb2021 (at the age of 73 years-old) for COVID-19 vaccination. Medical history included Parkinson's disease, bulging disc in the back and shoulder, anxiety, thyroid, had very bad case of, was in the hospital for 12 days and they were just supposed to put her on the ventilator, but then started to recover a little bit, was hesitating on taking the shot. But when she called the doctors they said no you can take it, even the neurologist said that you can take it because she had this disease and should be taking it. Historical vaccine included unspecified reaction from an unspecified flu vaccine on an unknown date. Concomitant medications included dexlansoprazole (DEXILANT), levothyroxine, paroxetine for anxiety, carbidopa, levodopa for Parkinson's disease, metoprolol succinate (METOPROLOL ER ACTAVIS) 25 mg, one a day and vitamin D NOS. On 05Feb2021, the patient experienced slight fever of a 100, felt cold, chills, headache, joint pain, muscle pain unbelievable, nauseous and was sick all day. On 06Feb2021, the patient's arm was very sore in the spot where they gave the injection and has no rash, it's not red in that area or any place else, It's just very sore and it hurts in the muscle, this is very sore in the spot where they gave the injection. On an unknown date in 2021, symptoms felt like when you are getting the flu and when you get the flu vaccine just a little more tiredness. Treatment to reduce the fever included acetaminophen (TYLENOL) and is sweating. Treatment was received for chills. The clinical outcome of slight fever of a 100, felt cold, chills was recovered on an unknown date. The clinical outcome of arm very sore in the spot where they gave the injection, headache, joint pain, muscle pain unbelievable, nauseous, sick all day, symptoms felt like when you are getting the flu and flu vaccine, tiredness and sweating was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
73 2021-03-13 lethargy, headache, fever Presented with fever and hypoxia - determined to be SIRS. No infectious source found. Other symptom... Read more
Presented with fever and hypoxia - determined to be SIRS. No infectious source found. Other symptoms included confusion, lethargy, aches, headache and fever.
73 2021-03-17 fatigue Extremely tired for the next month, and then was hospitalized with 2 blood clots in lungs and severe... Read more
Extremely tired for the next month, and then was hospitalized with 2 blood clots in lungs and severe anemia (cause not determined yet, as to whether not making platelets or losing blood). Had two blood transfusions and iron transfusion.
73 2021-03-17 malaise On 03/08/2021, patient began not feeling well. She complained of nausea, vominting and diarrhea. He... Read more
On 03/08/2021, patient began not feeling well. She complained of nausea, vominting and diarrhea. Her husband reported that she received the first vaccine in 02/2021 and complained of not feeling well. Patient died on 3/12/2021.
73 2021-03-18 malaise TIA; I felt really lousy; This is a spontaneous report from a contactable consumer (patient). A 73-y... Read more
TIA; I felt really lousy; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), dose 2 at the age of 73-year-old, via an unspecified route of administration on 26Feb2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure (don't have really high blood pressure but the doctor has her on blood pressure medicine, have no diabetes or whatever, and had allergies. Concomitant medication included amlodipine besylate 5 mg, taken every morning. She takes most of her medicines in the morning and had taken that stuff at about 5 o'clock or so early in the morning. The patient was previously vaccinated with the first dose of BNT162B2 on 05Feb2021 at the age of 73-year-old and hand no problem. The patient stated that when she had the first COVID vaccination she had no problem and then Friday she went to get the second one, it was 3 weeks later, when she had first one she stated that she had allergies, so they had her wait 15 minutes, no problem. When she went for the second one, thankfully someone drove her that was outside the 'game court' location. When they gave it they said, she pull up and will let her know after she pull up and will decide if she has to wait 15 minutes or 30 minutes and they asked her if she had allergies, and she said yes, they said pull over here and she has to wait 30 minutes and all she know was, it's probably 2 minutes from the time she got the vaccine until she got to the place to wait. She would say 15 minutes after she got it on 26Feb2021, she felt really lousy and told her friend, they 'said' she was having a Trans Ischemic Attack (TIA), and took me to the hospital and everything. An ambulance was called on 26Feb2021 at around 8 o'clock that morning, right after she had the vaccine and carried her straight in the hospital. She was discharged the next day 27Feb2021 at about 7 PM. The patient had a CT scan of her brain, MRI of her brain, and then cardial, something with reference to her heart, she forgot, all with unknown results. The body weight right now was about 150 pounds. The outcome of the events was unknown.
73 2021-03-22 sweating, cough Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history signifi... Read more
Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history significant for hypertension, hyperlipidemia, hypothyroidism, and breast cancer. She presented to the emergency department with reports of possible allergic reaction to Pfizer vaccine. Patient received her first dose of: Vaccine earlier today and approximately 5 minutes later developed a cough, diaphoresis, and lightheadedness. She was given 50 mg oral Benadryl in the ED. Patient then complained of tingling sensation throughout her body and was continuously coughing. She was brought to the emergency department for evaluation. Patient noted she felt jittery and "disconnected". In the ED her cough and dizziness significantly improved. Upon examination, patient was noted to have right lower extremity weakness. She denied any weakness. CT of the head was performed to rule out stroke. Neurology was consulted. CT head brain was negative however patient was still having right-sided weakness. Emergency department physician confirmed the patient was able to get up without difficulty after receiving her vaccine at 1415 immediately following her vaccine. It was determined she was within the window for TPA. Patient was transferred to the ICU for further management.
73 2021-03-24 fatigue Heart attack; she might have a little bit of heart cell damage; tired; This is a spontaneous report ... Read more
Heart attack; she might have a little bit of heart cell damage; tired; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN6207, Expiration date: Jul2021, NDC number was unknown), via an unspecified route of administration, in right deltoid on 10Mar2021 14:10 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history relevant to adverse event was not provided. The patient received historical vaccine of first dose bnt162b2 (Lot number: EL9267, Expiration date: May2021) right deltoid on 12Feb2021 for covid-19 immunisation. Patient did not receive prior Vaccinations (within 4 weeks). Caller is a retired Registered Nurse who states she felt it was important to report, that she had a heart attack 70 hours after receiving the Covid vaccine on 13Mar2021. Her doctor informed her she probably should report it. Caller states she's not 100 % sure it's the Covid vaccine. Informs she has no other cardiac issues, health issues or problems with medications, stating they narrowed it down. Patient was taken by ambulance and then to the Emergency Room. States she was admitted to the hospital and had testing done on heart, stress test echo, on heparin IV drip, aspirin. Hospitalized for 4 days. Patient states supposedly she will have a complete recovery, right now she is just tired. Was told she might have a little bit of heart cell damage on an unspecified date in Mar2021, but not anything really significantly. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. As per the reporter for the heart attack seriousness criteria reported as Life threatening and Caused/prolonged hospitalization. patient was in hospital for Heart attack from 13Mar2021 to 16Mar2021. As per the reporter drug result reporter as related. The patient underwent lab tests and procedures which included testing done on heart and stress test echo with unknown results in 2021. Therapeutic measures were taken as a result of heart attack. The outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile, there is possibility of causal association between the reported events Heart attack,Heart injury and the suspect vaccine BNT162B2 cannot be Excluded.Also there is limited information in the case provided,Consider also possible contributory effects from patient's medical history and surgical history.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
73 2021-03-25 chills, fatigue Chills; fatigue; Severe abdominal cramping; Gallbladder attack; This is a spontaneous report from a ... Read more
Chills; fatigue; Severe abdominal cramping; Gallbladder attack; This is a spontaneous report from a contactable consumer, patient. A 73-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscularly in the left arm on 26Jan2021 at 03:30 AM (at the age of 73-years-old) as a single dose (Batch/Lot Number: EI9262), and received the second dose intramuscularly, in the left arm on 16Feb2021 (at the age of 73-years-old) as a single dose (Batch/Lot Number: EN6201), for COVID-19 immunisation . Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included hydrochlorothiazide/ramipril (RAMIPRIL HCTZ). About a week after both Covid-19 vaccine injections, the patient experienced chills, fatigue, severe abdominal cramping, and gallbladder attack. The patient stated that the chills and fatigue, were expected, but she had severe abdominal cramping and what appeared to be a gallbladder attack. The patient did not have a sore arm or fever. No treatment was received for the events. The patient recovered from the events, chills, fatigue, severe abdominal cramping, and gallbladder attack.
73 2021-03-26 fatigue After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 day... Read more
After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 days went to urgent care checked out OK but symptoms persist to this day. On 3/13 severe dizziness and vomiting and blacking out and went to ER. Admitted overnight. Pulmonologist prescribed course of Prednisone on 3/15 and ending on 3/25. Some relief for chest tightness Neuropathy has gotten steadily worse with inclusion of face and lower leg. On 4th day began some ringing in ears which is to this day louder. Have fatiugue, sleep issues, trouble focusing my brain and eyes. Everything is worse today. Can't hold my head up. Will someone please help me
73 2021-03-28 fatigue Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high bl... Read more
Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high blood pressure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 02Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included hypertension and PCN allergies (penicillin allergy). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccine in four weeks. Concomitant medication included unspecified medication. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on Jan2021 15:15 as a single dose for covid-19 immunization. On 25Feb2021 06:00 PM, the patient was very tired, low energy (it has been almost 3 weeks), had one fainting episode though the patient doesn't know if it was related, and problems with high blood pressure. The fainting episode is reported, the other problems have been ongoing since second shot. The events required emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure was high on 25Feb2021 and nasal swab (sars-cov-2 test) was negative on 22Feb2021. The outcome of the events was recovering. Information on the lot/batch number for first dose has been requested.
73 2021-03-28 sweating within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itc... Read more
within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itch; blood pressure: 178/90; within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itch; This is a spontaneous report from a contactable other health professional (patient). A 73-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 73-years-old, administered in Arm Left on 25Jan2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included one kidney, left was removed due to cancer, no residual cancer, allergic to juniper. The patient was not pregnant. Concomitant medication included ezetimibe (ZETIA), escitalopram oxalate (LEXAPRO), pravastatin (PRAVASTATIN), and probiotics; all taken for an unspecified indication, start and stop date were not reported. Patient reported that, "Within 8-10 minutes of shot, I began to sweat under my arms, my chest and back and head began to itch. EMT took my blood pressure: 178/90, oxygen level was good. They called the EMT Ambulance, and transported me to the medical center > they treated me with IV Benadryl and steroids and I went home within two hours, with no further issues." The events started on 25Jan2021 12:00 PM. The adverse events resulted in Emergency room/department or urgent care, Hospitalization (0 days). The patient received IV Benadryl, steroids and prescription for Medrol for events. The patient underwent lab tests and procedures which included blood pressure measurement: 178/90 on 25Jan2021, oxygen saturation: good on 25Jan2021. The patient recovered on 25Jan2021 14:00. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination. Facility type vaccine was Health Clinic/Facility. At the advice of her allergist she declined to get the 2nd dose of the Pfizer vaccine. Her questions is should she take a the J&J vaccine and wanted to know if Pfizer could give guidance on the matter. Information about lot/batch number has been requested.; Sender's Comments: Based temporal association, the reported events in relation to suspected drug BNT 162b2 cannot be totally excluded. Case will be reassessed pending new information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
73 2021-03-30 runny nose Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-ye... Read more
Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 11:30 (Batch/Lot Number: EN6199) as single dose for covid-19 immunisation. Medical history included diabetic, arthritis, torn right shoulder, neuropathy plantar fasciitis arthritis back pain, allergies: sulfa, antibiotics, indomethacin, amoxicllin, sulfacetamide. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for an unspecified indication from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for an unspecified indication from an unspecified start date and ongoing; fluoxetine (FLUOXETINE) taken for an unspecified indication from an unspecified start date and ongoing; diclofenac (DICLOFENAC) taken for an unspecified indication from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for an unspecified indication from an unspecified start date and ongoing; metformin (METFORMIN) taken for an unspecified indication from an unspecified start date and ongoing; pregabalin (PREGABALIN) taken for an unspecified indication from an unspecified start date and ongoing; simvastatin (SIMVASTATIN) taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication from an unspecified start date and ongoing; amitriptyline (AMITRIPTYLINE) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced bells palsy on 12Mar2021 with outcome of not recovered, runny nose on 12Mar2021 with outcome of recovering. Clinical course: the consumer said that the Bell's palsy started Friday with a runny nose, her right side nostril. She said Saturday she had it where she can't move the right side of her face properly, and that is when she called to make her doctor's appointment for this morning. The reported events required visit to: Physician office. The patient received prednisone 1 daily for 7 days as treatment for the event Bells Palsy.
73 2021-03-30 headache She was been down for over a week, the Covid symptoms; weakness of bones; nauseous; headaches; she m... Read more
She was been down for over a week, the Covid symptoms; weakness of bones; nauseous; headaches; she missed the 2nd dose; Tested positive for COVID; Tested positive for COVID; sick; This is a spontaneous report from a Pfizer Sponsored Program. Two contactable consumers (patient's husband and patient herself) reported that a 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Mar2021, the patient tested positive for COVID, sick, she missed the 2nd dose, weakness of bones, nauseous, headaches, serious side effects and she was been down for over a week, the COVID symptoms on an unspecified date. He does not have any adverse reaction at all. The report was received as, he does not have any adverse reaction at all. The reason for call is not for him personally. It is for his fiance. For the first dose, he had his dose on 14Mar2021. Prior to that first dose, 3 weeks before that, is when he had first dose. She and him went together for first dose. She has one dose and had to go back to her hometown for a family emergency and was not able to go for second dose. In the interim, she got a COVID test and she tested positive. She did not come for second shot or they would have gone together. What does she have to do after testing positive and missing her second dose? He was going to have her call directly. He said she has all the information about what they used and what protocol for test she took. Reporter stated, "Well I have a situation. My wife and I on 7Feb2021 got our 1st dose. In the interim she had to go out of town to her family and she tested positive after her 1st dose. My question is, I went and had my 2nd dose on 14Mar2021. I got mine, but she didn't get hers. She would like to know, how long she had wait before she gets the 2nd dose." Reporter stated, "Since I have you on the phone you can get the side effects. She had serious side effects. She was been down for over a week, the Covid symptoms. She is not asthmatic. She had weakness of bones, nauseous, headaches no fever or coughs but all the other symptoms." She may be taking thyroid medications. That's all I know. Reporter stated, "I hope I don't have to go on hold for another 2 hours and 45 minutes." The doctor's don't know. She is recovering. I already spoke with the safety team and reported this.: Spoke from attached document and emailed as requested Spoke from (LAB- 1457-6.0 Revised: 25Feb2021) under section 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA "The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19." Therapeutic measures were taken as a result of she was been down for over a week, the COVID symptoms, sick, weakness of bones, nauseous, headaches and serious side effects with reported as, she is taking some vitamins. The patient underwent lab tests and procedures which included COVID-19 test: positive on 14Mar2021. The outcome of events was recovering. Information on the lot/batch number has been requested.
73 2021-04-01 sleepiness, fatigue Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in ri... Read more
Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in right eye/ Occasional shooting pain in eye; Eyes watering; Groggy; Dizzy; Extreme fatigue; Brain foggy; Forgetful; Sleep cycle distorted; Essential tremors in hands; Dull pain in back of head near neck; slightly garbled/ voice difficult to understand; Sensitive to loud noises; This is a spontaneous report from a contactable Other-HCP (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 01Mar2021 16:30 (Batch/Lot Number: en6198; Expiration Date: 01Mar2021) as single dose for covid-19 immunisation. Medical history included COPD. Concomitant medication included salbutamol (VENTOLIN [SALBUTAMOL]);and fluticasone propionate/ salmeterol xinafoate (ADVAIR). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: em9809) on 07Feb2021 04:00 PM, in left arm for covid-19 immunisation at age of 73 years old. The patient experienced eyesight was dimmed, even when she can manage to open her eyelids, occasional shooting pain in eye, eyes watering, throbbing pain mostly in right eye, Bell's Palsy partial facial paralysis on both sides: can't smile, voice difficult to understand, slightly garbled, groggy, dizzy, brain foggy, forgetful, extreme fatigue, sensitive to loud noises like dog's bark, sleep cycle distorted, essential tremors in hands are greater than usual, and dull pain in back of head near neck and all on 02Mar2021 05:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient is not pregnant. The treatment was received. No covid prior vaccination and no covid tested post vaccination. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown result on unspecified date. The outcomes of events were recovering.; Sender's Comments: Based on a plausible temporal association, the company cannot completely rule out a causative role of BNT162B2 to the onset of facial paralysis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
73 2021-04-01 headache Patient presented to the ER with a severe headache on 3/30. CT found subdural hematoma as well as i... Read more
Patient presented to the ER with a severe headache on 3/30. CT found subdural hematoma as well as intra-axial hemorrhage in the left axial lobe. The patient was life flighted from our facility.
73 2021-04-06 fatigue Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vo... Read more
Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vomiting; vision changes; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:00 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, glaucoma, Manages cholesterol, controlled high BP and iodine contrast. The patient's concomitant medications were not reported. The patient experienced neuropathy, shortness of breath, chest tightness , ringing in ears, fatigue, brain fog, dizziness, vomiting and vision changes on 10Mar2021 03:00. The patient was hospitalized for all of the events for 2 days on an unspecified date. The patient underwent lab tests and procedures which included Nasal Swab: negative on 13Mar2021. The patient was not pregnant. Outcome of the events was not recovered.
73 2021-04-17 fatigue Could understand words but could not answer back; Her symptoms came out as if she was having a strok... Read more
Could understand words but could not answer back; Her symptoms came out as if she was having a stroke.; Bad headache/migraine; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6207, expiry date: Jul2021), via an unspecified route of administration, administered in left arm on 19Mar2021 10:45 at single dose for COVID-19 immunization. The patient's medical history included diabetes from Jun2001 and ongoing. The patient's concomitant medication included metformin taken for diabetes from Jun2001 and ongoing. The patient previously received flu shot from immunization (she had the flu shot 20 years ago had bad reaction to). Facility where the most recent COVID-19 vaccine was administered was at the hospital. The vaccine was not administered at military facility. The patient received the vaccine on 19Mar2021 and she felt fine that Friday. On 20Mar2021 (Saturday), she started having a bad headache and took Aleve. She took Aleve 3 times 4 hours apart because she still had a bad headache. She started losing the ability to bring out words. She stated that her headache was gone. On 21Mar2021 (around 4 o clock), her husband was in the kitchen and asked her a question but could not understand her and asked again. She could not say the words but she could spell them. Her husband asked her another question, she tried to talk but she could not answer back. At that point her husband said they were going to the hospital. She was admitted for 3 days from 21Mar2021 to 23Mar2021. The doctor told her she was having a migraine because it had lasted for 2 days. She also spoke with her primary care provider, who looked it up and said this could be a side effect. She was told the migraine may take away the ability to talk. Her headache has been gone but continues to feel very tired (extremely tired since 19Mar2021). Her symptoms came out as if she was having a stroke on an unspecified date. The event 'could not understand words but could not answer back' required an emergency room visit.The patient underwent lab tests and procedures which included CAT scan, MRI, and contrast test, all with negative result on 22Mar2021. The outcome of the event 'could understand words but could not answer back' was recovered on 22Mar2021, the event 'bad headache/migraine' was recovered on 21Mar2021, not recovered for extremely tired, and unknown for the event 'stroke'.
73 2021-04-24 fatigue Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; ... Read more
Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 09Mar2021 12:00 (received at the age of 73-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included asthenia and known allergies to Sulfa drugs, NSAIDS. The patient was not pregnant. She did not have covid prior vaccination. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; and vitamins. The patient experienced extreme fatigue (fatigue) (disability, life threatening), decreased energy (asthenia) (disability, life threatening), needed to sleep most of the day (hypersomnia) (disability, life threatening), difficulty maintaining balance (balance disorder) (disability, life threatening), heart palpitations (palpitations) (disability, life threatening), all on 11Mar2021 04:00. These conditions started 2-3 days after the first vaccine (as reported). The adverse events resulted in Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient did not receive any treatment for the adverse events. Outcome of the events was recovered on an unspecified date in 2021. The patient was not tested for covid post vaccination.
73 2021-04-24 headache had a stroke; instantly had a pounding headache; blood pressure was elevated; This is a spontaneous ... Read more
had a stroke; instantly had a pounding headache; blood pressure was elevated; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 25Mar2021, she received the first COVID-19 vaccine and instantly had a pounding headache. She went to her doctor who said her blood pressure was elevated and was going to do more testing. She and her sister went away thinking she just needed to relax but then had a stroke in the hotel that same day and was in the hospital for 3 days (until 28Mar2021). She has never had high blood pressure and no history of headaches. The doctor in the hospital thought that this could be related to the vaccine since she had no high blood pressure or headaches before. She asked the doctors if she should get the second one and they all said they don't know enough about the vaccine to give her guidance. Outcome of the events were unknown. Information about the Lot/batch number has been requested.
73 2021-04-27 fatigue, throat pain This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration (injection), administered in the right arm on 12Feb2021 at 13:00 (batch/lot number: EL9267) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from 1991 and ongoing (diagnosed 30 years ago; doctor said that he didn't know if she has RA because she's taken all of those infusions and it may just be severe osteoarthritis), ongoing thyroid (disorder), thyroid was removed, knee replacement left leg from 2020 (she had knee replacement last year on her left knee), Achilles tendon tear - reported that she had to have surgery last to repair her right Achilles tendon as it tore, cholesterol (abnormal) from 1991 and ongoing (diagnosed with cholesterol problems 30 years ago), ongoing depression (diagnosed with depression a couple years ago), ongoing sleep problems (experienced sleep problems for a long time), blood pressure (abnormal) from 2013 and ongoing (diagnosed with blood pressure problems 8 years ago), physical therapy, lymphedema, and unable to recall exact dates. There was no family medical history. No prior vaccinations (within 4 weeks). Concomitant medications included amitriptyline taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); folic acid taken for arthritis from an unspecified start date and ongoing (she has been taking this medication for years and years); levothyroxine taken for thyroid, start and stop date were not reported (she has been taking this medication for years and years); chlordiazepoxide (LIBRIUM) taken for sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); losartan taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); meloxicam taken for arthritis from an unspecified start date and ongoing (began taking for 10 or 15 years after switching from celecoxib); metoprolol taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); omeprazole taken for stomach from an unspecified start date and ongoing (helps her stomach with all of the medications she has to take); pravastatin taken for cholesterol from an unspecified start date and ongoing (she has been taking this medication for years and years); desvenlafaxine succinate (PRISTIQ) taken for depression from an unspecified start date and ongoing (she started taking over a year ago, a year and a half or maybe two years ago); levothyroxine sodium (SYNTHROID) taken since thyroid was removed from an unspecified start date and ongoing (she has been taking since 15 years ago, for a long time); temazepam taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); cholecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date and ongoing (she has been taking this medication for years and years). The patient previously took BNT162B2 first dose on 21Jan2021 via injection in the right arm (lot number: EL3047 or EL3247; expiration date unknown) for COVID-19 immunization; and celecoxib (CELEBREX). The patient experienced extensive deep vein thrombosis on 06Apr2021; leg pain and feet swollen/ leg was like a balloon/ leg started to swell on 05Apr2021; throat hurts and tired on an unspecified date. The patient was calling about the Pfizer Covid-19 vaccine. She reported that she and her husband received both doses of the Pfizer Covid-19 vaccine. She received her first dose of the Covid-19 vaccine on 21Jan2021 and her second dose on 12Feb2021. She reported that she has had no complications before such as blood clots or problems with her blood or anything. She reported that on Monday, 05Apr2021, her leg started to swell. She reported that on the following day, 06Apr2021, her leg was so swollen that she couldn't put it down. She reported that she went to the emergency room on 06Apr2021 and was found to have an extremely extensive deep vein thrombosis. She reported that she was calling to complete a safety report. She stated that she doesn't want a deep vein thrombosis to happen to anyone else if her thrombus was from the Covid-19 vaccine. She reported that she and her husband thought they were so lucky as they had no side effects whatsoever following the Covid-19 vaccine doses. She reported that she was not saying that the deep vein thrombosis was from the Covid-19 vaccine but she has never had any blood or clotting problems in her life. Throat hurts: She reported that she thinks that when she was intubated, that whoever intubated her caught her tongue and cut it. She reported that she and her son and husband had been seeing news stories about the (Company name) vaccine. She reported that she has friends that were waiting for the (Company name) vaccine. She reported that her son wanted to send a text message so that others could be aware of the problems they might have. Leg pain: She reported that she went to the dentist on 05Apr2021 and was fine. She reported that when she got home from the dentist, her husband asked if she wanted to the take dog for walk. She reported that she put a leash on her dog and walked to the end of her driveway and said to her husband that she couldn't walk because her leg hurt so much. She reported that she had 2 surgeries last year, a knee replacement in her left leg and an Achilles tendon repair in her right leg. She reported that when she was released from physical therapy that the therapist told the caller that she might have lymphedema. She reported that the physical therapist directed her to go to a clinic that had no doctor where the clinic staff wanted her to buy a (dollar)10,000 piece of equipment to pump up her legs in the morning and at night. She reported that she came home from the clinic and called the podiatrist that repaired her Achilles tendon. She reported that she went to see the podiatrist that day and that the podiatrist ordered an ultrasound. She reported that a vascular surgeon called her regarding the ultrasound and stated that there was nothing wrong with the veins in her legs. She reported that the surgeon stated that they could tell there was nothing wrong with the her because her feet weren't swollen and instructed her to follow up in 9 months. She reported that on 05Apr2021, she went back into her house after experiencing the leg pain. She reported that her feet were not swollen and she was not that concerned. She reported that she thought maybe she was just tired and laid down. She reported that when she woke up the next morning, 06Apr2021, that her feet were like balloons. She reported that her son called a friend of his who was an orthopod. She reported that her son's friend instructed her son to take her to the emergency room, recommending that they bypass a certain hospital. She reported that she went to the emergency room on 06Apr2021. She reported that the emergency room staff did an ultrasound as soon as the caller arrived. She reported that the emergency room staff called the vascular surgeon. She reported that the vascular surgeon stated that if he had been in the caller's hospital room 5 minutes earlier that the would have done the surgery then, but that he had to lay her on her stomach to perform the surgery and she had eaten some cookies and drank diet soda. She reported that on the following day, 07Apr2021, the vascular surgeon put a scope in her vein and pulled out the clot. She reported that the physician was extremely concerned because the clots were very extensive. Leg pain: She reported that the leg pain was still ongoing. She reported that it hurts when she walks. She reported that she doesn't know if the leg pain has gotten worse. She reported that her leg pain on 06Apr2021 was excruciating and off the charts. Feet swollen: She reported that the swelling in her feet has maybe gotten slightly better. She reported that her feet were wrapped tightly with ace bandages. Leg swollen like a balloon: She reported that her leg was still swollen but it's gotten better, maybe about 90%. Extensive deep vein thrombosis: She reported that the deep vein thrombosis was removed on 07Apr2021 from her left leg. She reported that she was at end of her life and she had trips planned. She reported that she had a trip planned recently to go to Las Vegas with her daughter. She reported that her daughter was not able to take the trip, and stated she didn't know what would have happened if she had experienced the blood clot while in Las Vegas. She reported that she received both doses of the Covid-19 vaccine in her right arm, as she was in the car and her husband was driving. First dose: Date: 21Jan2021; Lot Number: She reported the lot number as EL3047, then stated that the handwriting was hard to read and that the lot number was either EL3247 or EL3047. She stated when reporting on her history that she has no concept of time and was unable to recall exact dates. She reported that while in the emergency room and during admission, the hospital staff did labs, but she has no idea what the results were. Vaccination facility type was drive through clinic at (clinic name). Vaccine administered at military facility: No. The adverse events leg pain, swelling in feet and leg, extensive deep vein thrombosis required a visit to the emergency room. Did not require a visit to the physician's office. The patient was hospitalized for 6 days for extensive deep vein thrombosis from 06Apr2021 to 12Apr2021. The patient underwent lab tests and procedures which included CT scan of chest: normal on an unspecified date, ultrasound: there was nothing wrong with the veins in her legs on an unspecified date, ultrasound: unknown results on an unspecified date. The outcome was not recovered for the event leg pain; recovering for the event feet swollen/ leg was like a balloon/ leg started to swell; and unknown for the rest of the events.; Sender's Comments: Reported events are assessed as intercurrent medical conditions probably associated to patients underlying conditions and are therefore unlikely related to BNT162B2.
73 2021-04-28 chills, dehydration didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; ... Read more
didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; blood pressure 82/50; skin tenting; dizziness/orthostatic dizziness/dizzy; Nausea vomiting; Nausea vomiting; chills and cold sweats; chills and cold sweats/all sweaty, cold; felt blah; sore arm after 2nd dose; This is a spontaneous report from a contactable nurse reporting for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received BNT162B2 on 16Mar2021 (at the age of 73-years-old) for COVID-19 immunisation and experienced Sore arm and feeling blah. Clinical course was as follows: She spent 50 years in neurology and neuroscience, she was a crazy RN that did neurology right out of school, she was recommended for that specialty. She is not sure if she had a reaction to the vaccine or if it is just her. Her 2nd dose was last Wednesday, 07Apr2021. She had a sore arm and felt blah. Just like after the 1st shot. On Saturday night (10Apr2021) at 0200, she was awakened with chills, cold sweat, dizziness, nausea and vomiting. She was sick as a dog for 2 days and didn't eat or drink much of anything. She went to the doctor who sent her to an infusion center. She is down to 5' 2" and weighed too much. She has not been able to lose weight for a couple years. She gained 40 pounds when she turned 50 years old. After the shot, she had a sore arm and felt blah like she did after the first dose, but she thought everyone felt that way. She missed a day of gym class because of her really sore arm. This got better like after a flu shot, it was nothing. This time she had a really sore arm and felt blah after the shot but then on Saturday morning this whole thing started happening. She woke up very restless, was all sweaty, cold, dizzy and was too miserable to try and take her blood pressure. Her blood pressure tends to run low. Her symptoms of the sore arm resolved at 06:00 Saturday (08Apr2021). She had nausea and vomiting and couldn't eat or drink. That lasted through Monday morning. She had some back pain with this, but she has back pain normally as she is a little old lady. She had a scheduled Oncology appointment Monday, as did her husband. She experienced orthostatic dizziness. She woke up plain dizzy. Her doctor gave her a liter of fluids and it helped her. This was something that needed to be addressed. It was serious. It was all serious. She had nothing left to vomit. She is an old lady with Breast Cancer. Her creatinine level of 1.10 which dropped her GFR of 52, she calculated the GFR using a computer program. This is what lead to the doctor giving her a liter of fluid. She had an appointment scheduled and her doctor sent her to the infusion centers for a liter of D5NS. She was sent home afterwards and encouraged to drink fluids. She also had a CBC and chemistry panel with her blood work. She was worried because her skin was tenting badly, and she couldn't keep anything down. She was probably dehydrated. Her blood pressure at the doctor's office was 82/50. She didn't care that her skin was tenting. She has been drinking a lot of fluids as advised after her liter of fluids at the infusion center. She is interested in researching the MRNA process because it is used it in other things. The way the vaccine was developed, it should have dissipated after 48 hours. She likes to research everything. She and her husband experienced a year from Hell starting in August of last year. All events are considered serious. The patient underwent lab tests and procedures which included blood creatinine: 1.10 and blood pressure measurement: 82/50 on 12Apr2021, blood test, full blood count and investigation with unknown results and glomerular filtration rate: 52 on an unspecified date. The outcome of the events chills and cold sweat was recovered on 12Apr2021, skin tenting and orthostatic dizziness was recovered on 13Apr2021, vomiting and nausea was recovered on 14Apr2021, pain in arm was recovered on 10Apr2021, feeling abnormal was recovered on an unspecified date, while of the rest was unknown.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
74 2020-12-31 lethargy Lethargic, not eating
74 2021-01-05 headache, chills Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptom... Read more
Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptoms started about 3:30pm and lasted from 6-8 hrs. Headache & sore arm lingering on 1/6/21.
74 2021-01-06 throat irritation, headache Headache, dizziness, chest tightness, scratchy throat; No treatments provided in clinic. Patient mon... Read more
Headache, dizziness, chest tightness, scratchy throat; No treatments provided in clinic. Patient monitored until EMS arrived. Patient care handed over to EMS.
74 2021-01-07 headache Headache; Itchiness; Phlebitis; Looks like little flea bites on her skin. There isn't that many, its... Read more
Headache; Itchiness; Phlebitis; Looks like little flea bites on her skin. There isn't that many, its mostly on her upper torso and they are sporadically placed.; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported), intramuscularly on the right deltoid, on 27Dec2020 (10:00) at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension; hypothyroidism; was allergic to shellfish probably over the last 20 or 30 years; and was allergic to penicillin and sulfa "many, many years ago". Concomitant medications included HCTZ for hypertension; losartan potassium (COZAAR) for hypertension; levothyroxine sodium (SYNTHROID) for hypothyroidism; amlodipine for hypertension; omeprazole for hypertension; and ongoing lansoprazole (PREVACID). The patient previously took Fluzone Quadrivalent influenza vaccine on 17Oct2020 for vaccination, and had itchiness. On 28Dec2020, the patient had headache; itchiness; phlebitis; and had what looked like flea bites on her skin which were not that many, and was mostly on the upper torso and sporadically placed. The patient had received diphenhydramine (BENADRYL) as treatment for the events. The patient was told that since itchiness was not a part of the normal side effects, the itchiness was considered an adverse reaction and that she could not get her second shot which was scheduled for 16Jan2021. The outcome of the events was recovering for 'headache', 'pruritus' and 'phlebitis'; and was recovered on an unspecified date for 'looked like flea bites on her skin'.
74 2021-01-11 chills, headache Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable cons... Read more
Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO142), via an unspecified route of administration in left arm, on 04Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history included arrhythmia, right shoulder reverse replacement, and fusion at L5S4. The patient's concomitant medications included metoprolol tartrate, digoxin, levothyroxine, and montelukast sodium (MONTEL). The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 04Jan2021 at 3:30 PM, the patient experienced headache, sore arm, vomiting, diarrhea, and chills. The events were considered non-serious. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.
74 2021-01-11 fever, chills, fatigue Pt started experiencing severe temperature night of 1/08/2021 with chills very fatigue. Severe all o... Read more
Pt started experiencing severe temperature night of 1/08/2021 with chills very fatigue. Severe all over the body.
74 2021-01-12 chills, headache Got really sick overnight; Headache; Chills; Body aches; Nausea; Joints hurt; This is a spontaneous ... Read more
Got really sick overnight; Headache; Chills; Body aches; Nausea; Joints hurt; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration on 04Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disorder. Concomitant medications included levothyroxine from an unknown date at 100 (units not provided) for thyroid. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on an unknown date (at the age of 74-years-old) as a single dose for COVID-19 vaccination. After the patient received the second BNT162B2 vaccine dose, overnight the patient got really sick, the patient experienced headache, chills, body aches, nausea, and joints hurt, all on unknown dates in Jan2021, per the patient it started during the night. The patient received ibuprofen (ADVIL) as treatment for the events. The clinical outcome of got really sick overnight and chills were unknown and the outcome of the events headache, body aches, nausea, and joints hurt was not recovered. It was also reported that the patient has been tested for COVID-19 with unknown results, the patient stated they get a COVID test every week at work.
74 2021-01-13 fatigue, malaise tiredness; stress; feeling terribly; This is a spontaneous report from a contactable consumer (patie... Read more
tiredness; stress; feeling terribly; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date Apr2021) intramuscular on 31Dec2020 11:30 at single dose in the left arm for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient called for information about if severe tiredness and stress are symptoms reported for the administration of the Pfizer's COVID-19 vaccine and how to properly manage them. The patient reported that she was administered with the Pfizer's COVID-19 vaccine on 31Dec2020 and since then she has been experiencing severe tiredness and stress (31Dec2020). The patient reported that she has spoken with her physician and he could not provide guidance about how to proceed with this particular situation. She received the first dose of Pfizer Biontech Covid vaccine on 31Dec2020. She was feeling terribly, she has severe, severe tiredness that comes over her and stress. She was overwhelmed by what was happening to her and she was asking if anybody else has experienced this. Her second dose was supposed to be on 21Jan2021. The outcome of the events severe tiredness, feeling terribly and stress was not recovered.
74 2021-01-13 chills, sleepiness very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site;... Read more
very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3246, expiry date not reported), intramuscular on 05Jan2021 13:30 at a single dose in the upper left arm for COVID-19 prophylaxis. There were no medical history and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient asked if there was any contraindication to getting the second dose. Patient reported having vomiting and shivers the day after receiving the vaccine as well as pain at injection site which was reportedly now resolved. Patient was calling about the Covid-19 vaccine and reported that she received the vaccine this past Tuesday 05Jan2021. She said that she was very sick the next day (06Jan2021). She said that 5 people went with her to get the vaccine and she was the only one who had gotten sick. Patient clarified that she had vomiting throughout the day the next day after receiving the vaccine. She also reported that she had shivers for hours and hours. She said that she had blankets and quilts on her and she could not stop shivering. She said that when she went to the doctor, the doctor thought it was because of the vaccine. Patient wanted to know if she should she take the second shot and if these will happen to her again or not and asked if there are any contraindications. She said that the vomiting started in the morning around 10:00 on 06Jan2021. It lasted a couple of hours until about 13:00 06Jan2021. She said that the shivers were bad, and she had big time shivering and there was nothing she could do to stop the shivering. The shivering lasted from 10:00 06Jan2021 until about 5-6 in the evening 06Jan2021. As the day progressed the pain where they gave her the shot was very bad on 05Jan2021. She said that she had pain at the injection site (pain injection site) on 05Jan2021. She said that it only hurts now if she touches the area. She said that the site previously it hurt without touching it. Patient was very weak and sleepy the next day. She said that she felt very weak and sleepy on 07Jan2021. She said that it lasted throughout the entirety of the day and she fell asleep and felt better today (at the time of the report). She said that today she felt fine. The events did not require emergency room visit but events required physician's office visit. The events were reported as not serious. Therapeutic measures were taken as a result of the events weak and sleepy. The patient recovered from vomiting on 06Jan2021 13:00, from shivers on 06Jan2021, from weak and sleepy on 07Jan2021. The patient was recovering from pain injection site. The outcome of the event sick was unknown.
74 2021-01-14 fever fevers of 101; getting worse; she is so sick; felt 'nausea, chilly and hot'/she is feeling hot; fel... Read more
fevers of 101; getting worse; she is so sick; felt 'nausea, chilly and hot'/she is feeling hot; felt 'nausea, chilly and hot'/nauseous; arm been sore; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 09:30 at single dose for prevention. Medical history included covid-19 from Jul2020, hair loss. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fevers of 101 on an unspecified date with outcome of unknown, felt 'nausea, chilly and hot'/nauseous on 08Jan2021 with outcome of not recovered, felt 'nausea, chilly and hot'/she was feeling hot on 08Jan2021 13:00 with outcome of not recovered, getting worse on an unspecified date with outcome of unknown, arm been sore on 06Jan2021 08:00 and on 08Jan2021 08:00 with outcome of not recovered, she was so sick on an unspecified date with outcome of unknown. Clinical course: She had it on Tuesday and arm been sore since then. now she gotten very nauseous. Her temperature is around 98 degrees Fahrenheit now and she is feeling hot. She does not have a temperature. After transfer caller stated ' I felt nauseous but now its gone, but also getting worse.' She was usually 96 or 97 degrees Fahrenheit. She was nauseous. Is this normal after 4 days. There was no prescriber. She was more sore on Wednesday than she is now. It is better yesterday and now than on Wednesday when it was real sore. She did something she should not have done. She went to a yoga class and had not eaten. Afterwards, she had a strawberry and did not feel like eating. Then she said she did not take her pills, which are mostly vitamins. The thought of taking pills made her sick. After she took them she ate something and has been nauseous ever since. She did not confirm if she needed glasses prior to getting the vaccine. She had COVID in Jul2020. She is taking a lot of vitamins. She had hair loss and is taking Biotin. She takes very few prescribed medications. Now she was so sick she would not think of taking them. No further details provided. The patient underwent lab tests and procedures which included body temperature: 98 degrees fahrenheit on unknown date. Information on the Lot/batch number has been requested.
74 2021-01-17 pneumonia patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pne... Read more
patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pneumonia
74 2021-01-18 fever, chills At approximately 4pm on Jan 11, 2021, I began to have hard chills and fever that reached 104.9. I wa... Read more
At approximately 4pm on Jan 11, 2021, I began to have hard chills and fever that reached 104.9. I was admitted to ICU at the Hospital. My blood pressure dropped to dangerous levels. I was diagnosed with sepsis and the doctors determined it was caused by the vaccine.
74 2021-01-19 headache Unable to move head and neck due to soreness
74 2021-01-20 throat irritation 30 minutes after immunization, patient complained of "fat tongue", swelling feeling to left side of ... Read more
30 minutes after immunization, patient complained of "fat tongue", swelling feeling to left side of tongue, scratchy throat-"strep like feeling", and metallic taste, described as nail polish remover taste. 50 mg po was administered and MOD contacted, pt was monitored for 20 minutes at which time patient stated symptoms had improved and was feeling fine. Patient was kept another 30 minutes before patient left. At time of discharge patient stated was feeling drowsy from Benadryl but was doing well otherwise.
74 2021-01-20 headache, chills Got shot at 12:45 pm and at 6 pm the night I started feeling a little cold and by 7 pm I was really ... Read more
Got shot at 12:45 pm and at 6 pm the night I started feeling a little cold and by 7 pm I was really cold with chills and a headache. It lasted 24 hours.
74 2021-01-21 headache As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my... Read more
As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my body was on fire. Also add headache could not hardly stand to lay my head on the pillow. About 4 AM I could not tolerate the situation any longer and took 600 mg of Tylenol. After that was able to rest some. The next day after the vaccination my joints were achy moderately and I have a headache. The injection site was tender to the touch and arm range of motion decreased and arm sore. Took 400 ibuprofen about 4 PM day after injection to ease Reactions
74 2021-01-21 headache, chills Chills, muscle ache, headache.
74 2021-01-21 chills, fatigue, headache, malaise Day 1 - nothing Day 2 - nausea (mild progressing to severe), vomiting (x2),... Read more
Day 1 - nothing Day 2 - nausea (mild progressing to severe), vomiting (x2), dull headache, no appetite, fatigue, chills (on/off) Day 3 - nausea (moderate), Pancreatitis-like symptoms (lasted 1 day), no appetite, fatigue, erratic blood sugars, chills (on/off) Day 4 - fatigue, chills (on/off), no appetite, generally feeling unwell. Day 5 and continuing, generally not feeling well, no appetite, chills (on/off) NO FEVER AT ANY TIME
74 2021-01-22 malaise, throat irritation, fatigue Do not know if the symptoms were related to the vaccine. They started 4-5 days after Pfizer Covid-19... Read more
Do not know if the symptoms were related to the vaccine. They started 4-5 days after Pfizer Covid-19 vaccination. Intermittent Scratchy throat, stuffy sinuses, extreme fatigue felt as if I was coming down with or fighting a cold. Symptoms lasted on and off for about 4-5 days. Nothing materialized. After that I felt fine
74 2021-01-23 chills, headache Approx 7:00pm on the 22nd of January had a dull headache. The next day had muscle pain, joint pain... Read more
Approx 7:00pm on the 22nd of January had a dull headache. The next day had muscle pain, joint pain, and chills. Also injection site was sore. Took Advil for pain and aches.
74 2021-01-23 chills Starting about 11PM, left arm from fingers up my arm to below my ear, across to my right shoulder ac... Read more
Starting about 11PM, left arm from fingers up my arm to below my ear, across to my right shoulder ached, had chills, and could not get comfortable in bed. Once up at 7 AM took two Advil 200mg with relief
74 2021-01-24 headache Approximately 10-15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. BP:... Read more
Approximately 10-15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. BP: 160/60, HR: 70, RR: 24-28, O2 sats: 98%. No other symptoms noted. Pt. assessed local EMS. Declines going to emergency room today. Pt. plans to go to urgent care or call PCP.
74 2021-01-24 headache Approximately 15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. Pt. wa... Read more
Approximately 15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. Pt. was immediately assessed by Physician. Also assessed by local EMS. BP: 160/60, HR: 70, RR: 24-28, O2 sates: 98%. Pt. declines to be transported to the emergency room. Plans to make appt. with PCP.
74 2021-01-24 headache, chills, sleepiness, fever, malaise Developed hives on my face, on my head, on top of my back and they also itch in addition to the all ... Read more
Developed hives on my face, on my head, on top of my back and they also itch in addition to the all over itching; headaches; Pain around my face, my left arm; Developed severe itching from head to toe; I was running a temperature of 102; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; Appetite lost; Chills; soreness more than usual from the shot; Soreness in my arm, my neck; Soreness in my arm, my neck/ pain around her face, her left arm; I got stiff neck, my back, my lower back; Massive weakness; Confusion; terrible sleepiness; Diarrhea; I still don't feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3248, expiration Apr2021) at 6:00AM on 07Jan2021 for Covid-19 immunization. The patient had her first dose on 19Dec2020 and had side effects from it but very few. The patient was worked at COVID rooms to clean rooms in hospital as a housekeeper and so her exposer to the hospital made her in first group to get the vaccine. Medical history included allergies (had anaphylactic shock from Amoxicillin and from Tylenol, she cannot take Tylenol), anxiety, and high blood pressure. Concomitant medications included acetylsalicylic acid (ASPIRIN) on regular basis, bisoprolol fumarate, loratadine (CLARITIN) for allergies, escitalopram for anxiety, mometasone furoate (FLONASE) for allergies, losartan, magnesium, omeprazole, and triamterene. On the first day (07Jan2021) she had soreness more than usual from the shot, soreness in her arm, her neck. She got stiff neck, back, lower back. She had gotten the shot at 6 am, then worked at that time and by the time she got home at noon, she had massive weakness, some confusion, terrible sleepiness and by evening, she developed diarrhea. On the second day (08Jan2021) the pain increased the weakness increased, and she was running a temperature of 102. She could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move pretty much. She could not eat and lost appetite, and she developed the chills on that evening. On the third day (09Jan2021) she was running a temperature of 101 so it had gone down. She still had headaches, and pain around her face, her left arm and developed severe itching from head to toe, and on the next day (10Jan2021) she developed hives on her face, on her head, on top of her back and they also itch in addition to the all over itching. The temperature was gone, she had no temperature when she developed the hives. At the report day, she stated that she had not gone back to work as she broke out in the horrible hives and she still did not feel good. Only cold ice packs on the hives/ itching and no more treatment received for the events. The fever and itching resolved on 10Jan2021, and outcome of all other events was unknown.
74 2021-01-24 fatigue, headache, sleepiness Injection at 7:30 p.m. Noticed frequent yawning. Went to bed early, tired. Awoke earlier than usual.... Read more
Injection at 7:30 p.m. Noticed frequent yawning. Went to bed early, tired. Awoke earlier than usual. Slight headache that continued until it got troublesome so took Advil iii plus Tylenol500 i with coffee. Relief from headache but continued tired. Mild headache returned mid afternoon. Bed early at 9:p.m. but headache (especially in the bones behind my ears) was keeping me awake so I took Advil iii plus Tylenol 500 with half cup coffee. (This was the pain relief regimen that my dentist had recommended and it had been effective) Woke up this morning feeling fine.
74 2021-01-24 fatigue Lack of energy Feel exhausted
74 2021-01-24 headache, fatigue injection site pain, fatigue, headache periodically, muscle and joint pain
74 2021-01-24 sleepiness received 3 shots of COVID vaccine; almost "like fell asleep". She was hardly open her eyes this morn... Read more
received 3 shots of COVID vaccine; almost "like fell asleep". She was hardly open her eyes this morning/couldn't eat dinner because people couldn't wake her up; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications were not specified (reported the patient was taking bunch of medications, but the reporter did not know exactly what they were). Historical vaccine included first dose bnt162b2 on 24Dec2020 and second dose bnt162b2 on 11Jan2021, both for COVID-19 vaccination. She didn't have any side effect from the first shot or the second shot. The patient received 3 shots of COVID vaccine, received 1st dose of vaccine on 24Dec2020, 2nd dose on 11Jan2021. Then inadvertently given another dose yesterday, on 12Jan2021. Immediately after the 3rd dose of vaccine, the patient almost "like fell asleep". She was hardly open her eyes this morning. The patient was in a nursing home. The nursing home staff was finding it difficult to feed her now. The patient couldn't eat dinner because people couldn't wake her up. The patient just had the COVID test, no other lab test. The outcome of the events was unknown. Information of lot/batch number has been requested.
74 2021-01-24 throat irritation symptoms of rash and scratchy throat two weeks after injection
74 2021-01-25 chills, headache Headache, chills, diarrhea for 5 days, then better for a day, then it started again to a lesser ext... Read more
Headache, chills, diarrhea for 5 days, then better for a day, then it started again to a lesser extent. Now 11 days out I am better. Sometimes have mild headache.
74 2021-01-25 fever Initially soreness around injection site later followed by vertigo, nausea and vomiting. which reso... Read more
Initially soreness around injection site later followed by vertigo, nausea and vomiting. which resolved after 48 hours. Dizziness continued and on fourth day I developed body aches, low grade fever (100.9) and nausea. which lasted for three days.
74 2021-01-26 fatigue, headache, malaise, cough, fever, chills Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no a... Read more
Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no appetite; This is a spontaneous report from a contactable consumer reported for self. This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246) via unspecified route of administration at 08Jan2021 10:30 AM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The age at vaccination is reported as 74 years old. The patient medical history and concomitant medications were not reported. The patient previously received benzoin and experienced allergy. The patient experienced severe headache, tiredness, muscle pain, chills, fever 99.7, joint pain, feeling unwell, cough, no appetite at 15Jan2021 18:00 PM. The events are reported as non-serious by reporter. The patient received no treatment. The patient was not diagnosed with COVID-19 prior to and since the vaccination. The patient was recovering from the events.
74 2021-01-26 nasal congestion, headache, chills Strong nasal Congestion, head ache, and chills.
74 2021-01-26 fever, chills fever; severe chills/could not get warm; her breathing was deep; drop in blood pressure; mild swelli... Read more
fever; severe chills/could not get warm; her breathing was deep; drop in blood pressure; mild swelling/Swelling of Left Arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration in the left arm on 11Jan2021 10:00 at a single dose for COVID-19 vaccine (because she's 74 and high risk). Medical history included hypertension. Concomitant medication included irbesartan oral (by mouth) from an unspecified date (maybe 3 years ago) and ongoing at 300 mg once daily (150mg, 2 tablets once a day in the morning) for hypertension as blood pressure medication. The patient received the first dose of vaccine on Monday (11Jan2021) morning (AM) at 10 at the county (public) health department. She had no problem at all until yesterday Tuesday, she experienced mild swelling; the swelling happened in the upper left arm (swelling of left arm) which started on 12Jan2021, this was also the same side that she got her vaccine on, the left arm. On 13Jan2021 she woke up at 4AM [also reported as thirty (30) hours after the shot] in which she started to have severe chills (horrendous chills), could not get warm under the blanket for an hour and a half. It lasted a long time. Her severe chills did stop, she used an electric (heated) blanket. This morning on 13Jan2021 at 8:30, she woke up with the fever, which she was able to reduce with acetaminophen (did take two acetaminophen). Her fever was also gone. She was a little concerned because she thought her breathing was deep too on 13Jan2021. She did some relaxing breathing which helped. It lasted a long time. The patient also experienced a drop in blood pressure on 13Jan2021. Her blood pressure has been running the past few days at 133/80 on 11Jan2021. Today (13Jan2021), she took her blood pressure and it was at 93/50. It went to 87/56 after drinking some salty soup on 13Jan2021 (the bottom number in the blood pressure was going up a little, and the top number was going down a little). Her blood pressure has been normal 133/70 on Jan2021, but this morning it was 90/50 on 13Jan2021. Her blood pressure has been running normal the last couple of days like 133/90 on Jan2021. She was shocked it was lower. She knew they talk about dizziness and weakness, but she didn't experience that. She was concerned about that sudden drop in blood pressure. She did some research and started eating some salty soup and stuff (has been drinking salty soup). Her bottom number went up to 53 on Jan2021. She was concerned about that drop there. She was wondering if that was a side effect of the vaccine (result of the vaccine). She asked if drop in blood pressure was a concern. She had no positive test for Covid before the vaccine. She never had any tested, she's been pretty isolated. She had no antibody test. She has had no issues with vaccine in the past. Therapeutic measures were taken as a result of severe chills/could not get warm, fever, her breathing was deep, and drop in blood pressure. The outcome of swelling of left arm/mild swelling and drop in blood pressure was not recovered; of severe chills/could not get warm was recovered on 13Jan2021 05:30 and fever was recovered on 13Jan2021; and of her breathing was deep was recovering.
74 2021-01-26 fatigue, headache tiredness for 6 hrs after receiving shot; muscle aches on arm receiving shot and slight headache nex... Read more
tiredness for 6 hrs after receiving shot; muscle aches on arm receiving shot and slight headache next morning.
74 2021-01-27 fatigue, headache Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday m... Read more
Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday morning
74 2021-01-27 cough Patient states right after she received the vaccine, she had a small "coughing spell" for the first ... Read more
Patient states right after she received the vaccine, she had a small "coughing spell" for the first 15 minutes. The coughing stopped. When the patient went home she noticed hives on her face and upper chest that lasted 1-2 hours and went away on their own.
74 2021-01-27 fatigue, chills, cough, headache, lethargy, fever Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, ... Read more
Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, not able to do much No appetite Urine strong odor, different color, and frequent Cramping in hands and feey
74 2021-01-27 fatigue tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, up... Read more
tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included anxiety (needed to calm down), blood pressure abnormal, blood cholesterol abnormal, rheumatism, and osteopenia; all were ongoing. Concomitant medications included losartan potassium for blood pressure abnormal, atorvastatin blood cholesterol abnormal, sulindac for rheumatism, carvedilol for blood pressure abnormal, alendronate sodium for osteopenia, and venlafaxine; all were ongoing. On 12Jan2021, the patient experienced strong pain on her shoulder, upper arm, breast and neck area. On an unspecified date, the patient was also tired. Clinical outcome of event tired was unknown while for the other events was recovered on 13Jan2021.
74 2021-01-28 chills Chills, joint pain, no fever, muscle ache
74 2021-01-28 fever Severe urgent diarrhea; Feels like she might be getting a little fever; This is a spontaneous report... Read more
Severe urgent diarrhea; Feels like she might be getting a little fever; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration to right deltoid (shoulder) on 15Jan2021 at around 10:30-10:40 AM at a single dose for COVID-19 immunization. Medical history included chronic fatigue syndrome, fibromyalgia, problems with her colon, back surgery, and flashes. Concomitant medications included ibuprofen given on unspecified date for back surgery, and unspecified hormones, vitamins, and laxatives. The patient previously received the flu vaccine on unspecified date and experienced like she got the flu and relapse of her chronic fatigue syndrome. She also received hepatitis C vaccine, hepatitis B vaccine, pneumonia vaccine, and shingles vaccine; all on unspecified dates. The patient had not received prior vaccinations within four weeks. On 15Jan2021, the patient experienced severe urgent diarrhea and felt like she might be getting a little fever. It was further described as: Patient had an odd reaction within maybe 30 minutes to 1 hour after that dose was administered of severe urgent diarrhea. Patient mentioned she felt like she might be getting a little fever; but she was not sure and did not have a thermometer to check that. Severe urgent diarrhea: She mentioned she had not seen that side effect posted anywhere for the vaccine so she felt it was an odd reaction; although she did see that it was a side effect of the virus, so maybe it was not that odd of a reaction for the vaccine now that she thought about it. She described this event as completely crazy, the urgency to go to the bathroom, she almost did not make it home to the bathroom. It just hit her like she has never experienced before. It cleaned out her colon really well. She also felt like she might be getting a little fever but mentioned that at her age she gets hormone flashes so it could be that; and was humid at the time of report and thought so it could just be from that. The outcome of the events was unknown. Information regarding Batch/ Lot number has been requested.
74 2021-01-28 chills, headache, fatigue Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours aft... Read more
Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours after vaccination Symptoms still present, but beginning to improve after 48 hours
74 2021-01-28 fever Started running a fever of 100 12 hours later
74 2021-01-30 chills, headache Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body ac... Read more
Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body aches and chills. Left arm sore for three days.
74 2021-01-31 fever, headache, chills Constant headache fever ( 99.7) chills achy muscles no appetite Feeling somewhat better 48 hours lat... Read more
Constant headache fever ( 99.7) chills achy muscles no appetite Feeling somewhat better 48 hours later -- but not all better
74 2021-01-31 fever Fever 101F. Shingles noted on 2nd day. Took Enbrel injection on01/23/2021
74 2021-01-31 cough Pt has a history of asthma. Pt states after she recieved the vaccine she started coughing. Pt states... Read more
Pt has a history of asthma. Pt states after she recieved the vaccine she started coughing. Pt states she used her albuterol inhaler. Pt states she also took 50MG of benadryl. Pt states her symptoms are gone at this time. Pt's vitals are stable. Pt refused transport to hospital.
74 2021-01-31 fatigue, headache Two hours after the vaccine I had heart palpitations, my lips were tingling and I felt fatigue and a... Read more
Two hours after the vaccine I had heart palpitations, my lips were tingling and I felt fatigue and appetite loss. This lasted about 30 minutes. 36 hours after vaccine I experienced headache, swollen tender left lymph node above collarbone and elevated BP 167/90. This improved after taking Advil.
74 2021-01-31 fatigue exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; so... Read more
exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; sore left eye; blood pressure very high and hard to control; shingles; This is a spontaneous report from a contactable consumer. A 74-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 08Jan2021 13:30 at single dose for covid-19 immunisation. Vaccine location was left arm. No other vaccine was received in four weeks. Medical history included hypertension, neuropathy peripheral, asthma/allergies, headache, allergy to medications, food. Concomitant medications included azelastine, fluticasone propionate (FLONASE), metoprolol, gabapentin, levothyroxine sodium (LEVOTHYROXINE). The patient experienced shingles on 08Jan2021 (immediately after she got the shot), exhausted on 09Jan2021 03:30, slept most of day/night on 09Jan2021 03:30, pain in scalp, pimples, bumps on 09Jan2021 03:30, sore left eye on 09Jan2021 03:30, blood pressure very high and hard to control on 09Jan2021 03:30. Patient was treated with Valacyclovir, lisinipril, metropolis, aquafor. The outcome of shingles was unknown. The outcome of exhausted, slept most of day/night, pain in scalp, pimples, bumps, sore left eye, blood pressure very high and hard to control was not recovered.
74 2021-02-01 chills Cant get her breath, intensely weak, chills.
74 2021-02-01 chills, fever low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once; ... Read more
low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once; chills; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247) via an unspecified route of administration on the arm left on 18Jan2021 11:00 at single dose for COVID-19 immunisation. Medical history included thyroid. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid and ongoing. The patient did not receive other Vaccinations within 4 weeks. The patient had low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once on 19Jan2021, chills on 19Jan2021. The event did not require a visit to physician or emergency room (ER). The caller stated she took the first dose of the vaccine yesterday (18Jan2021) and today (19Jan2021) has had a low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once. Fever was reported as worsened. Today 19Jan2021, she first noticed the chills, now she did not have chills but she had a fever that was going up. She is scheduled to receive the next dose of the vaccine 08Feb2021. The outcome of the event fever was not recovered, of the event chills was recovered on 19Jan2021.
74 2021-02-03 fatigue, chills, headache, malaise she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; ... Read more
she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; fogginess/Foggy brain was described as she was not able to focus very well; Strong chills was not going away almost like a feeling of ice in her veins; Arm ache at the site; She was not able to get work done due to extreme fatigue and foggy brain/It was very disturbing and interfering with ability to do work; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had her first COVID19 vaccine dose. Immediately, on 16Jan2021, she felt very cold and unwell. She also experienced dizziness, headache that started right after the shot, extreme fatigue that started later in the day and fogginess that started right after the shot. Strong chills was not going away almost like a feeling of ice in her veins. She is taking paracetamol (TYLENOL) and ibuprofen for these. The events were not improving. She was just surprised, she was ok with a day's worth, but it was hanging on dizziness (not enough to fall down), but she has to hold onto a rail to go upstairs which was not normal. She doesn't feel like she is real anchored. Headache was described as very bad and is not changing. Foggy brain was described as she was not able to focus very well. She was not able to get work done on Jan2021 due to extreme fatigue and foggy brain. She also experienced arm ache at the site on 06Jan2021 for which the patient expected. It is reducing some, the ache is not as bad as it was while the other things seem to be growing and it is still there. She had to be set aside when she took the shot, because she had these reactions after she got the shot. She had to be watched because of her almost immediate reactions. The patient wants an advice on what to do now, if there is any help for the side effects, and if this will go away. It was very disturbing and interfering with ability to do work. Outcome of the vaccination site pain was recovering while of the remaining events was not recovered.
74 2021-02-04 chills, fever, sleepiness Day 1: nothing Day 2: dizzy, chills, extreme sleepy, fever of 102.2, fever broke during sleep at nig... Read more
Day 1: nothing Day 2: dizzy, chills, extreme sleepy, fever of 102.2, fever broke during sleep at night Day 3: nothing
74 2021-02-04 fatigue, fever First dose : Second day of vaccination very mild fatigue , moderate pain in arm Second dose : ... Read more
First dose : Second day of vaccination very mild fatigue , moderate pain in arm Second dose : pain in the arm began the day of vaccination, second day at noon began chills, fatigue, joints pain and and fever at around 4 pm , highest reading 100.4 Third day feeling good for
74 2021-02-05 malaise About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site p... Read more
About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site pain and swelling, muscle and joint pain, feeling unwell
74 2021-02-05 influenza like illness, headache, chills Unable to lift arm and soreness. Flu like symptoms - muscle aches, chills, headache
74 2021-02-06 headache Severed headache Couldn?t lift arm
74 2021-02-07 chills, headache, cough Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning... Read more
Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning plastic; Taste started to diminish; Painful bilateral lower back pain; Cough/Dry cough; Bad headache; Severe shaking chills; Muscles and joints ached; Muscles and joints ached; This is a spontaneous report from a contactable nurse (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration at left deltoid on 20Jan2021 at 9:30-9:45 am at SINGLE DOSE for COVID-19 immunization. Medical history included exposure to radiation from 2017 to an unknown date and did lose some of her sense taste due to 2 massive doses of radiation in 2017). There were no concomitant medications. Historical vaccine included two doses of shingles vaccine (SHINGRIX) for Immunization and experienced shaking, chills, and muscle and joint pain after the vaccine. The patient experienced bad headache (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, Severe shaking chills (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, muscles and joints ached (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, couldn't hold a cup to drink on an unspecified date with outcome of unknown, painful bilateral lower back pain on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, cough/dry cough on 20Jan2021 17:00 with outcome of not recovered (reported as worsened), strange odor in her nose, like burning plastic on 21Jan2021 with outcome of not recovered, taste started to diminish on 21Jan2021 with outcome of not recovered, pharangitis on an unspecified date with outcome of unknown, couldn't get warm on an unspecified date with outcome of unknown. Details were as follows: the patient received the COVIED in the morning of 20Jan2021. By 5pm she had developed a headache, severe shaking, chills, muscle and joints pain, severe lower back pain, and a dry cough; she was miserable. A few years ago after her double dosing of the shingles vaccine she had a similar reaction of shaking, chills, and muscle and joint pain. She has no product details for that product, no NDC, Lot, or expiry to provide. The patient confirmed that the shingles shot was 2 doses, not a double dose given at one time. When asked a seriousness criteria it was explained that the symptoms that started on the 20th, she felt they were disabling. She couldn't get warm, stop shaking, couldn't hold a cup and the pain was severe and she has high tolerance for pain. By around 3pm that day on the 21Jan2021 everything but the dry cough had resolved, and that had gotten worse. She also developed new symptoms. She had strange odor in her nose, like burning plastic and her sense of taste started to diminish. She did lose some of her sense taste due to 2 massive doses of radiation in 2017, She has no product information, NDC, Lot or Expiry for that radiation but after that she did have taste, some of it did come back. On the 21Jan2021, it was less, the sense of taste and now today she has no taste at all. For the muscle and joint pain she took Aleve. She was told if she was feeling worse over the weekend to go to the ER or urgent care. The patient was wondering and thinking this was her normal response to the vaccine just like she had a normal response that shingles vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
74 2021-02-07 fever, chills Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Un... Read more
Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Unable to sleep, restlessness! Lower legs itch. Site is sore! Had been to to not take ibuprofen or Tylenol to help antibodies form! Can I take Benadryl? I had none of these adverse effects with 1st dose!
74 2021-02-08 headache Diagnosed with sixth nerve palsy; Diarrhea; Headache; Nausea; This is a spontaneous report from a co... Read more
Diagnosed with sixth nerve palsy; Diarrhea; Headache; Nausea; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiry date: Mar2021), via an unspecified route of administration on 02Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. Concomitant medication included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), calcium (CALCIUM), rosuvastatin (ROSUVASTATIN). The patient experienced double vision and diagnosed with sixth nerve palsy on Jan2021, diarrhea and headache and nausea on 2021. The reporter stated "I am calling in reference to reporting possible side effect or adverse reaction to the vaccine. It is in reference to my mother, she had the first dose on 02Jan2021 and 14 days later, she started with double vision, ended up in the hospital. She was in the hospital 4 days (4 nights), diagnosed with sixth nerve palsy." The patient was hospitalization from 18Jan2021 to 22Jan2021. Reporter stated, "She was in hospital, she has visiting nurse now for physical therapy that comes to house and they going to redraw her labs tomorrow Wednesday. They were basically normal, all the lab results were normal." Therapeutic measures were taken as a result of double vision, diagnosed with sixth nerve palsy. Outcome of the events was unknown.
74 2021-02-08 fever, chills started with acute symptoms chills, fever, nausea. aches, and after i started to feel better and th... Read more
started with acute symptoms chills, fever, nausea. aches, and after i started to feel better and then full body rash from my face down my whole body.
74 2021-02-09 sleepiness, fatigue, malaise She was tired.Fatigue; she just could not get out of bed, she was sleepy; Did not feel good; This is... Read more
She was tired.Fatigue; she just could not get out of bed, she was sleepy; Did not feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET3248, expiration date was not reported), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included thyroid disorder and hypertension which the patient mentioned that she does not have really but she takes hypertension medicine. Concomitant medication included levothyroxine sodium (SYNTHROID) and amlodipine besilate, telmisartan (TELMISARTAN AND AMLODIPINE) which was a substitute of TWYNSTA with LOT# is 3108115, expiry date: Oct2021. The patient had her vaccine on 19Jan2021 which was a Tuesday, and on 20Jan2021 on a Wednesday, she had side effects and then she started feeling better like on the Friday. But just a while ago, she had another side effect episode. She queried how long these will last or what do she needed to do. She asked if she can take her vitamins and everything else. She mentioned that she had to go back to her second one on 09Feb2021. She was tired. She just could not get out of bed, she was sleepy. She just did not feel good and kind of fatigued. Events all on 20Jan2021 on a Wednesday with outcome of recovering.
74 2021-02-10 lethargy pt became lethargic, stopped eating. No fever; no nausea
74 2021-02-10 fatigue she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to... Read more
she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.
74 2021-02-12 body temperature increased, chills Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccin... Read more
Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccine. Itching started that evening. Next day went to PCP who ordered 3 doses of prednisone 20mg and benadryl 25mg every 6 hours PRN. Day 2, rash/welts increased as well as itching. Evening of day 2, rash to legs progressed to purpura, temp of 102.7, chills and extreme pain to bilateral hips which prompted taking to ED and being admitted to progressive care unit.
74 2021-02-16 malaise During the 15 minute observation period, patient began to not feel well complaining of difficulty wa... Read more
During the 15 minute observation period, patient began to not feel well complaining of difficulty walking and a strange feeling in her legs. When she did not improve and continued to have difficulty walking, she was transported to the ER for continued monitoring and evaluation.
74 2021-02-17 fatigue A 74-years-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspec... Read more
A 74-years-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on 27Jan2021, at 74 yeras of age, at single dose for COVID-19 immunization. The patient's medical history included allergy to codine. The patient was not pregnant at the time of vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC). On 27Jan2021 by 15:00 the patient felt extremely tired and her eyes burned a lot. The reported events resolved on an unknown date without any treatment. . Information on the lot/batch number has been requested.
74 2021-02-17 head discomfort, chills, malaise, dehydration, fatigue Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kid... Read more
Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kidney failure and allergic reaction; Allergic Reaction; still wasn't feeling normal; Could not keep head up and was in bed; breathless; extreme fatigue; exhausted and weak; Heart was banging fiercely; Totally dehydrated; Urinating a great deal more; Chills, shakes and felt terrible; Chills, shakes and felt terrible; sicker every single day/sick/felt terrible; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on the left arm on 18Jan2021 14:30 at a single dose for prevention for COVID. Medical history included hip replacement on 04Jan2021 and fibromyalgia (When her children were younger, she was told she had Fibromyalgia). Family history includes diabetes (father late onset) and very rare cancer (mother). There were no concomitant medications. It was reported that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and got sick the next day (19Jan2021). She also mentioned that she got sicker every single day. Then after 8-9 days, she said she started to feel better, but still wasn't feeling normal. She said she had extreme fatigue, was breathless, and felt exhausted and weak on an unspecified date. She said she was supposed to receive the 2nd dose of the vaccine this Monday (unspecified date), but because of her side effects, she was told that she can come back to receive the 2nd dose after 6 weeks. She wants to know if this is acceptable. The patient reported that on 19Jan2021, she woke up in the middle of the night with chills, shakes, and felt terrible. She cancelled her plans for Tuesday (as reported). On Wednesday, she forced herself to get up and went out for lunch and came home. She could not keep her head up and went back to bed and that lasted several days. It got worse before it got better. She ended up being hospitalized for 4 days (25Jan2021 to 29Jan2021). It appeared to be she was in Kidney Failure and experienced allergic reaction on 25Jan2021 and her white blood cell count was elevated (unspecified date). She went to the ER and they kept her 6-8 hours and discharged her on a Friday and by Monday, she was admitted to the hospital. The first ER visit, she was there for 6-8 hours and they sent her home. They gave her IV fluids and took a lot of tests. The patient's first ER visit was on 22Jan2021, and was kept for 6-8 hours and released. She was given IV fluids and they did a lot of tests. She went to see her doctor and sent her to the emergency room. They took her blood, EKG and everything seemed ok. Creat was 1.0 and by Monday it was 1.6 and then on Friday it was 1.9 (unspecified dates). She was admitted to hospital on Monday and they gave her IV fluids and did kidney test and admitted her as soon as she could get a room. She never had a problem before with her kidneys. They did bacteria test and they were normal. The patient called her doctor on 24Jan2021, because she was nauseous, dizzy, and room was spinning and she felt worse. She went to his office on Monday morning and he put her right in the hospital (unspecified date). She got worse and now it is improved. Heart was banging fiercely on 22Jan2021 20:00. They took an Echocardiogram. She has never had a cardiac problem and could not find anything wrong with her heart. The patient started feeling a bit better. She was sick as can be through Sunday. By Tuesday (unspecified date), she was a little better and today is a little better. She is urinating a great deal more because of fluids, but later said it started the day after she got it. She had to get an aide to take care of her. The patient experienced totally dehydrated on 22Jan2021 14:00 and urinating a great deal more on 19Jan2021 03:00. Therapeutic measures were taken as a result of kidney failure, allergic reaction and white blood cell count was elevated. The outcome of the events sicker every single day/sick, chills, shakes and felt terrible was not recovered; event could not keep head up and was in bed recovered with sequel; events nausea, dizziness and room spinning, heart was banging fiercely, totally dehydrated, urinating a great deal more was recovering; while unknown for the rest of the events.
74 2021-02-21 headache, chills Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then co... Read more
Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then cold chill stopped back and head ache pain continues till Saturday 20th am Tylenol was taken didn't help much I continue to get slight headache as of today 22nd Monday fine now except slight head and back pain
74 2021-02-21 chills side effects started about 8 pm in the evening , my skin started to itch like crazy and broke out in... Read more
side effects started about 8 pm in the evening , my skin started to itch like crazy and broke out in hives all over my body but not on my face. The next morning i woke up and saw a dermatologist who said if sounded like it was from the injection. prescribed Allegra once a day and Benadryl 4 times a day. the next morning, my bottom lip was swollen. then my face broke out in hives in the evening and with i would wake up it was gone but i did have two puff pockets under my eyes. i called my primary care Dr. My Dr prescribed me the epi pen just incase she needed it. Friday i also had chills By Saturday i stated to improve. I was taking antihistamine and Benadryl together. By Sunday i started to take less of the Benadryl and by Monday i has stopped al together.
74 2021-02-21 headache swollen neck, very limited head mobility (but improving), excruciating headaches; diagnosed at Emer... Read more
swollen neck, very limited head mobility (but improving), excruciating headaches; diagnosed at Emergency Department as bilateral posterior neck pain. The question I need answered is, IS IT WISE TO TAKE THE SECOND SHOT on 3/1?????
74 2021-02-22 fatigue Extremely tired and aches all over. Slight upset stomach. No appetite.
74 2021-02-23 fever 12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sle... Read more
12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sleep entire night.
74 2021-02-23 chills Extreme drop in blood pressure: Vaccine at 3:30 PM first drop @ 5:15 Pm to 84/51 HR 93; @ 5:50 PM 8... Read more
Extreme drop in blood pressure: Vaccine at 3:30 PM first drop @ 5:15 Pm to 84/51 HR 93; @ 5:50 PM 80/41 HR95; 7:00 PM 128/60 HR 50; 3:40 AM 85/46 HR 58-Irregular. This continued -the up 7 down till this writing (2/24 @ 9:30 AM). Also body aches, chills, barely able to move. No headache this time. Almost forgot - vomiting from 8:00 PM (2/23) till midnight (approx). I have vision difficulty from time of vaccination till now. I think that is all. General not feel goods!
74 2021-02-23 fever swollen neck lymph nodes five days after shot; My left arm was swollen; low grade fever; This is a s... Read more
swollen neck lymph nodes five days after shot; My left arm was swollen; low grade fever; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1283), via an unspecified route of administration (left arm) on 21Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included cholesterol (abnormal) from an unknown date. Patient is not pregnant. No other vaccines were given in four weeks. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. Concomitant medications (medications in two weeks) included pravastatin from unspecified date for cholesterol (abnormal); estrogens conjugated (PREMARIN), allopurinol (ELAVIL), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX) from an unspecified date for an unspecified indication. The patient experienced low grade fever on 25Jan2021 that went away but the following morning on 26Jan2021, the patient also experienced swollen neck lymph nodes five days (five days as reported) after shot. Patient stated she does not know if it was going away. Patient's left arm was also swollen on 26Jan2021. Left arm was described as swollen just little bit, not much but that's gone down. The patient stated there was no fever as of reporting, but the swollen lymph node was being reported and since she has been up, it's gone down considerably but she can just feel them a little bit on her neck. Treatment was not given. She mentioned she has a person coming to do a work at the house and wanted to know if it is okay if she still comes. She asked if she should be alarmed about the side effect. She mentioned she was just concerned about if she needs to be concerned about this or if she can be around people. She mentioned she wear masks anyways but just need to know if it is okay if people come into her home. Outcome of the events low grade fever and left arm was swollen was recovered on Jan2021, while unknown for swollen neck lymph nodes five days after shot.
74 2021-02-24 headache, fever Feb. 19 upon going to bed about 10:00; muscle aches in shoulders, arms, legs, knees. Feb 20 upon wak... Read more
Feb. 19 upon going to bed about 10:00; muscle aches in shoulders, arms, legs, knees. Feb 20 upon waking about 5:00AM; headache, continuation of pain muscles and joints, fever 101.3. Feb22 I don't know if related to vaccine, but fever blisters.
74 2021-02-24 fatigue On Sunday i started to get Very light headed and off balance and very very tired.
74 2021-02-24 head discomfort on 2/24/21 noted discomfort starting on scalp on top of head going down to left eyebrow, onto left o... Read more
on 2/24/21 noted discomfort starting on scalp on top of head going down to left eyebrow, onto left orbit down face on left side of nose, also a fever blister on bottom lip starting 2/22/2021,discomfort continues. have not called M.D. Lysine ointment on lip. no other treatment
74 2021-02-25 chills, headache, fatigue I had heavy chills from 6pm on the 24th until 2am on the 25th. Then, more heavy chills from 6am on ... Read more
I had heavy chills from 6pm on the 24th until 2am on the 25th. Then, more heavy chills from 6am on the 25th until 1 pm on the 25th. My headache was moderate but relentless throughout those days and into the 27th. I was extremely tired, having no energy or interest in doing anything but lying down. My body ached all over and I was somewhat dizzy and nauseated. I took a Tylenol during the night of the 25th. Today is the 26th and I am still very tired and my eyes are bleary.
74 2021-02-25 fatigue, malaise I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM... Read more
I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM I went to bed because I didn't feel good, I laid in bed for a few minutes and then jumped up because I began to violently vomit. After I vomited I felt weak, I was sitting with my back against the wall my husband came to check on me. He walked away and when he came back I was unresponsive, laying on the floor and he said my eyes rolled in the back in of head. He called 911. I was unresponsive for about a 1-2 minutes. EMS arrived, by the time they had arrived I had crawled into bed, and they took my vitals and they were fine, they asked me if I wanted to go to the hospital but I declined as I was afraid to go. I went to sleep. The next day I felt weak and tired, I had a burning feeling in my stomach, I took some TUMS, I didn't much that day. I rested most of the next day. Yesterday I felt a little better and today I am fine. I have a doctor's appointment 2/26/2021 at 2PM to see the ARNP at my doctor's office.
74 2021-02-25 headache, fever, chills Sore arm headache muscle aches fever chills
74 2021-02-25 fatigue, chills, fever, headache WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WE... Read more
WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WEEK 3: periodic chills, periodic headaches, weakness, periodic exhaustion, GI symptoms, elevated pancreatic enzymes WEEK 4: weakness, GI symptoms, shortness of breath, exhaustion, heart block
74 2021-02-26 runny nose, fatigue 15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drain... Read more
15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drainage and slightly bloody nostril. Tired in evening of injection, slight soreness right are. Next day, up performing usual home kitchen activities, reading, making and drinking coffee. Then SUDDENLY at exactly 23 hours after the injection, began experiencing extreme difficulty breathing, unable to speak in full sentences. Called Primary Providers Office and was directed to go to an emergency room ASAP.
74 2021-02-26 chills Chills gone next morning
74 2021-02-26 fatigue, chills I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chill... Read more
I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chills and an all over listless feeling that started about 18 hours after I received vaccine and still remains 4 days later
74 2021-02-26 chills, sweating PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS ... Read more
PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS STARTED. SHE WAS SENT TO THE ED FOR EVAULATION.
74 2021-02-27 chills Chills 2nd day: Sciatica seizing up hips area. Joint pain in both knees
74 2021-02-27 fatigue, chills, fever Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the n... Read more
Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the next day with a fever at 5pm of 100.5; Sunday no temperature but loss of taste, diarrhea, stomach discomfort.
74 2021-02-27 chills, fatigue Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash.... Read more
Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
74 2021-02-27 headache Severe headache, nausea and vomiting
74 2021-02-27 fatigue, chills Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle ... Read more
Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
74 2021-02-28 chills, fever At 10am on Thursday February 25, I SUDDENLY experienced the onset of violent chills, shaking so hard... Read more
At 10am on Thursday February 25, I SUDDENLY experienced the onset of violent chills, shaking so hard I couldn't initially place a thermomenter in my mouth. Moments later, this was accompanied by throbbing pain in my lower back. Eventually I was able to take my temperature and I had fever. My daughter contacted my primry care physician who told us to go the emergency room. By the time we went to hospital, the chills had stopped as well as the lower back pain. I was quarantined (though they knew I had been vaccinated for COVID) until they tested me for COVID, the test came back negative in an hour. They did a number of tests and I was discharged around 6:00 pm that evening
74 2021-02-28 headache, sleepiness, fatigue Sunday morning I woke up 5:30am with a mild headache. I had a cup of coffee & toast and 5:45 took ... Read more
Sunday morning I woke up 5:30am with a mild headache. I had a cup of coffee & toast and 5:45 took 1 500mg Tylenol. Felt sleepy, so went back to sleep. I took Tylenol 6 hours later, but this time added 2 tablets of cold calm. Then did drink water throughout the day. Slept afternoon and felt a bit better by 5pm. Took an other Tylenol at 8pm and did not take cold calm. Woke up 5:10 Monday morning, feeling much rested and no headache. I see my Primary Doctor on Thursday and will tell her my reaction.
74 2021-02-28 headache headache, full body aches for 36 hours
74 2021-02-28 fatigue, headache rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitatio... Read more
rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitations; quivering in chest and palpitations; lightheadedness; tired; anxious; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on 22Jan2021 at 15:30 at a single dose on left arm for COVID-19 immunisation. Medical history included triglycerides high, obesity, blood clotting issues, thyroid disorder and blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, rosuvastatin calcium, aspirin (acetylsalicylic acid) and vitamin D3. The patient experienced rapid heartbeat, headache, quivering in chest and palpitations, lightheadedness, pain in her arm at the injection site, tired on 23Jan2021 and anxious on 22Jan2021. The patient stated that on Saturday (23Jan2021), she noticed pain in her arm at the injection site, a headache, and feeling of like she was quivering in her chest. She was also experiencing palpitations, lightheadedness, and periods of rapid heartbeat. On Monday, the symptoms were a little less but yesterday and today she has had a lot of palpitations, quivery feelings in her chest and rapid strong heart beats. On Saturday, she took an aspirin for headache. On Sunday, she had just a mild headache and by Monday (25Jan2021) it was gone. She wanted to know if these are normal reactions and if she should call the doctor, or what she should do about them. The patient underwent lab tests and procedures which included blood triglycerides: high and body mass index: high on Jan2021; heart rate: rapid on 23Jan2021. Therapeutic measures were taken as a result of headache. The outcome of the events pain in her arm at the injection site and headache was recovered on 25Jan2021, while of the rest was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116966 same reporter/drug, similar events, different patient
74 2021-03-01 chills, headache, sweating sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass ou... Read more
sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization. Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00. The patient outcome of the events was recovering.
74 2021-03-02 headache Bad headache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old fem... Read more
Bad headache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8920, expiry date unknown), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated that she had a very slight case of COVID in Nov2020 and her family doctor told her about three weeks ago that she needed to get the vaccine. However, he did not tell the patient that she needed to wait 90 days from when she had COVID (as reported). So, she got the Pfizer vaccine about two months and a week after she had COVID itself. Ever since about five days after she had the vaccine, on an unspecified date in Jan2021, she came down with a bad headache and have had a headache since that day. She is on day nine of a headache and this is the headache that require medication. It is not the headache that you think is going way because it has not. She wanted to know if she got the headache because she got the vaccine too soon after having COVID. The patient got medicine for the headache because she had to go to the emergency room for the event. She had blood work done on an unspecified date but had unknown results. The outcome of the event was unknown.
74 2021-03-02 chills, headache, fever Fever 99.6, headache (similar to sinus headache) body aches, chills all day, next day headache rema... Read more
Fever 99.6, headache (similar to sinus headache) body aches, chills all day, next day headache remains took Tylenol
74 2021-03-02 headache, fever, chills Fever; Chills; Aches and pains; hurting all over; Headache like my head was going to explode; This i... Read more
Fever; Chills; Aches and pains; hurting all over; Headache like my head was going to explode; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3302; expiration date: unknown) at vaccination age of 74-year-old via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included type 2 diabetes, autoimmune thyroid disease and complex migraine (migraine chronic, complex migraine). The patient's concomitant medications were not reported. The patient reported that last Friday (29Jan2021, also reported as two weeks later), she got a fever, chills, aches and pains. She was hurting all over and she had a headache like her head was going to explode. So, she wanted to know could that be a delayed reaction to the shot (vaccine). The patient mentioned that treatment for the problems included acetaminophen, butalbital, and caffeine (FIORICET). The outcome of the events was unknown.
74 2021-03-02 headache, malaise Nauseated; Fogginess; Light headache; Just not feeling general malaise, Do not feel good; This is a ... Read more
Nauseated; Fogginess; Light headache; Just not feeling general malaise, Do not feel good; This is a spontaneous report from a contactable nurse (patient herself). A 74-year-old female patient BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EN5318, Expiry date: 31May2021), via an unspecified route of administration on left deltoid, first dose on 30Jan2021 13:30 at single dose for COVID-19 vaccination. Medical history included condition on thyroid from an unknown date and unknown if ongoing for thyroid. Concomitant medication included levothyroxine. Patient had given her side effects. She had her vaccine 2 days ago (30Jan2021 13:30). She have had fogginess and have been nauseated, light headache and just not feeling, general malaise, all on an unspecified date in 2021. Due date of Second Vaccine was on 20Feb2021. Treatment in response to the event was trying to get liquids and rest. She got the vaccine at an hospital. Patient had a thyroid test, CBC test and a CMP, they are all normal and had COVID test that was negative on unspecified dates. The action taken in response to the event was unknown.
74 2021-03-02 fatigue a rash all over [her] body; A swelling face; Being tired; This is a spontaneous report from a contac... Read more
a rash all over [her] body; A swelling face; Being tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient experienced a rash all over her body, a swelling face, and being tired on an unspecified date after receiving the first dose of the COVID-19 vaccine. She said that her throat was ok, hadn't itch and she doesn't have a fever. The outcome of the events was unknown. Information about batch/lot number has been requested.
74 2021-03-02 fever chest pains; fever over a 100°F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report... Read more
chest pains; fever over a 100°F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose on 25Jan2021 and experienced health issues in Jan2021 as AFib, diabetic, COPD, stomach issues, and reported to "have a lot of issues". The primary doctor thought it's better for her to get the dose than get COVID-19. Patient also reported that about 20 minutes after the first dose on 25Jan2021, patient had chest pains, from one side clear across the other side and took a Nitro, and patient had fever over a 100 degree F for 24 hours. The outcome of the events was unknown. Information on about lot/batch number has been requested.
74 2021-03-02 chills, cough, fever, headache fever, chills, HA, vomiting, diarrhea, chest tightness, SOB, nonproductive cough; received 1000 mg a... Read more
fever, chills, HA, vomiting, diarrhea, chest tightness, SOB, nonproductive cough; received 1000 mg acetaminophen, GI cocktail, liter ND, liter LR, zofran on discharged, mild tacyhpnea with accessory muscle usage (minimal); abdominal tenderness in epigastric area,
74 2021-03-02 fatigue, headache light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen... Read more
light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Did not sleep well overnight (always do) and woke up very tired; sick to stomach; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248, expiry date not reported), via an unspecified route of administration in the left arm on 30Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Raynaud's phenomenon. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received fluvastatin sodium (LESCOL) and experienced drug hypersensitivity, and nifedipine (ADALAT) and experienced drug hypersensitivity. On 30Jan2021 17:30, in the evening the patient became light headed, had a slight headache and was tired. Her upper arm became sore and a bit swollen. She did not sleep well overnight (always do) and woke up very tired, sick to stomach. Her upper arm was more swollen and sore. No therapeutic measures was taken as a result of the events. Clinical outcome of the events was recovering.
74 2021-03-03 malaise Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too ... Read more
Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too much of anything, just sit/ sick; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9269), intramuscular from 30Jan2021 17:00 (5pm) in the left arm at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a Pharmacy (Pharmacy/drug store). Medical history included ongoing thyroid condition diagnosed at least 10 years ago. Concomitant medication included levothyroxine (LEVOTHYROXINE) at 50mcg tablet once a day by mouth (Taking it for years) for Thyroid/ thyroid condition. For prior vaccinations: The higher dose, senior dose of the flu shot (for immunization), she stopped taking it when the lower dose came out. She gets very sick with the senior dose. She does not know the name and does not have lot number of the senior dose of the flu shot to provide. It was stated to the patient that there may be too much protein in it. The patient is asking if she should get 2nd dose after having negative experience post vaccination of 1st dose. The patient received first dose of vaccine on sat (30Jan2021) evening. It was reported that as soon as she got to her car, "I thought I felt numbness in my cheek. It didn't stay, went right away. My husband thought i was just nervous. It was also stated that she then started "getting nauseous" about 30min after vaccine. The patient has "been sick since I had it.. not sure if its normal? It was also reported that she "had the runs" (diarrhea) for one day, that has now resulted. It was also said that "I'm not feeling good. cant do too much of anything, just sit". The patient asked if this is normal and "when will I feel better"? It was also reported as she had the first dose of the Pfizer covid vaccine late Saturday afternoon at 5pm. She has been feeling nausea and sick since then. She asks if this is normal and how long it will stay. The treatment used was taking Tylenol. It was noted that if she does not do anything and lays down it will go away but if she starts doing too much she will get real nauseous again. It was added that the patient and her husband went to get the vaccine on the same day. It was noted that she felt a little numbness on her face, in her right cheek and then it went away after 20 to 30 seconds. Her husband said she may have been nervous and may have caused that herself. She is a hyper type. The outcome of the event Felt numbness in my cheek recovered on 30Jan2021; for all other events was unknown. There was no additional vaccines administered on same date. No events requires visit to emergency room or physician office. No prior vaccinations (within 4 weeks) reported.
74 2021-03-03 fatigue I had some of the listed side effects. i.e., pain and redness at injection site and fatigue. However... Read more
I had some of the listed side effects. i.e., pain and redness at injection site and fatigue. However, by Feb 21 noticed swelling under my armpit on the left side as well as somewhat swollen nodes in the left side of my neck. The swelling under my arm became worse over the next two days. When I raised my left arm I felt considerable pain. Over the next 2 days I also had swelling in my left forearm near bend in my elbow. I also had a rash the size of a patch above the injection site. I looked this issue up online and found reports that approximately 16% of women who had received the 2nd Covid shot experienced swelling under the armpit. I contacted my doctor by e mail . I switched from taking tylelnol to advil. All side effects are gone except there is still a little swelling in armpit. I contacted my Doctor and will see her on March 15th if the swelling is not gone.
74 2021-03-03 fever, lethargy Severe pain (entire arm) and redness; feverish/temperature fluctuations-highs and lows for her; extr... Read more
Severe pain (entire arm) and redness; feverish/temperature fluctuations-highs and lows for her; extreme itching at site; lethargy; reporter let person know these events not terribly unusual, vaccinee (sp?) wanted to report because continuing to have this
74 2021-03-03 fatigue, body temperature increased, headache Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right... Read more
Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right arm; A little headache at the back of the head; Itching; More pain when l lift my arm, my arm pits/Hurting under her arm when she was lifting; Swollen glands; My temperate was 100.8; had difficulty lifting her right arm; Tired, very tired; Tenderness at vaccinate site; More pain when l lift my arm, my arm pits/pain in arm/pain in her right arm/a lot of pain; I feel tugging and redness when I raise my arm, It's not red its blotchy; I feel tugging and redness when I raise my arm, It's not red its blotchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly at site of right arm on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included (synthroid: Taking for years), prevent urinary tract infection (UTI) (methenamine: started a year and a half ago), vitamin supplementation (Preservision Areds 2 eye vitamins more than a year ago; Vitamin C with Zinc 8-9 months ago), dry eyes (Thera tears: dry eye therapy. she has not been consistent with taking), cholesterol (simvastatin: taking 20 years or more), allergic to Sulfa Drugs and Tetracycline, obesity (had been fighting it for 30 years), removed polyps (had a flat polyp that was a little more dangerous the first time and it was removed; non-cancerous), got the flu (08Jun months later, got the flu, went to the hospital and developed PNA) and eczema (took calcium 1200mg). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid; methenamine for prevent UTI; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) for vitamin supplementation; ascorbic acid, zinc (VITAMIN C WITH ZINC) for vitamin supplementation; carmellose sodium (THERA TEARS) for dry eyes; simvastatin for cholesterol; calcium for eczema. The patient previously took Flu vaccine (Injection site was left arm, intramuscularly) in Oct2018 and experienced pain in injection site and redness in arm; took the first dose of BNT162B2 with lot number: EL3246, intramuscularly in left arm site at 09:00 on 08Jan2021. Clinical course: After the second dose of vaccination, patient noticed tenderness at vaccinate site at 13:00 and had pain in arm on 28Jan2021, but on 29Jan2021, the pain was worse, and she had difficulty lifting her right arm at 16:00. On 30Jan2021, she started noticing more pain when she lifted her arm, her arm pits, it was hurting under arm when she was lifting. She thought maybe there were swollen glands but did not feel it. her temperate was 100.8, and she took some paracetamol (TYLENOL), by the evening, her temperature was at 98.6 normal. On 31Jan2021, she noticed a lot of pain, itching and redness, redness moved from actual site down her arm about 6 to 7 inches at 14:00. The pain in her right arm was not as bad as it was, but the redness in the area and itching was there, it was hot to touch area on right arm, and she tried cold compresses and took paracetamol. Also, it was hurting under her arm when she was lifting. She experienced something like that before with a Flu vaccine. She noticed when she looked it up, the information states, yes. And it was still going on today, not so much pain, just swelling and redness, looked like what Moderna calls a covid arm. She had no temperature, a little headache on 31Jan2021 at the back of the head and tired, very tired, she was tired from 29Jan2021, and was better from 01Feb2021. She took paracetamol last night, and cold compress. she used to take baby aspirin; she didn't know if it would be a problem. She read not to take paracetamol or ibuprofen before vaccination. She felt tugging and redness when she raised her arm, it was not red its blotchy. She didn' t feel any swelling. The last 7 to 8 months, she was running high blood counts, 12.3 (high) and she had no infection, her doctor was a little nervous, the last one on 15Jan2021, it was down to 10.2 within normal range. Her immune system was very active. She had a flu shot in Oct2018 at age of 72 y/o and by 08Jun months later, she got the flu. She went to the hospital and developed PNA. In 2019 and again this past Aug2020, she had a Colonoscopy where they removed polyps. She had a flat polyp that was a little more dangerous the first time and it was removed. It was non-cancerous. The doctor was just watching it. Last blood results were 2 weeks prior to having first shot on 15Jan2021. The only thing that showed was her Liver enzymes were a little elevated. She was told that if she hadn't gotten the vaccine, it would have been worse, her doctor gave me the zpack. They were calling it a subcutaneous sensitivity, she had eczema, she forgot to mention that. She was taking calcium 1200mg, she forgot to tell her that also. The outcome of events pain in arm, redness and feeling hot was not recovered; of events tiredness, body temperature increased, itching and headache was recovering; of rest events was unknown.
74 2021-03-03 headache, chills, fatigue, throat pain Within 4 hrs of receiving the vaccine (on Saturday), developed headache, fever, chills, sore throat,... Read more
Within 4 hrs of receiving the vaccine (on Saturday), developed headache, fever, chills, sore throat, sore arm, fatigue. Symptoms faded during following day (Sunday) and by Monday left only with fatigue which resolved by Tuesday.
74 2021-03-03 chills Woke up Whole body and hands uncontrollably shaking Chills shaking
74 2021-03-03 fever, headache, chills initially had low grade fever, headache, chills that started 6-8 hours after the vaccine then abated... Read more
initially had low grade fever, headache, chills that started 6-8 hours after the vaccine then abated, went for routine physical examination and found to be hypertensive, BP over 140 systolic taken 3 times in the primary care physician's office. Later began doing BP monitoring at home, BP running from 130-140 with a high of 154 systolic, diastolic 70-78. There have been no associated headaches, dizziness, etc.
74 2021-03-03 fatigue, malaise pain in her arm; tired; feeling unwell; This is a spontaneous report from a contactable nurse (patie... Read more
pain in her arm; tired; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 74 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration (on left arm) on 27Jan2021 13:30 (at the age of 74-years-old), single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the vaccine last Wednesday. Since then she has had pain on her arm mostly on the upper side of the arm. She took Tylenol and it went away. Adds she felt so tired and generally unwell, like the flu. Mentions it is like muscle pain in her left arm that come back whenever she moves around. All of this started on Wednesday. Adds it is not that severe, like if you have the flu. Mentions she does get muscle pain sometimes when she is working around the house but this is different. She is scheduled for the second dose of the vaccine 17Feb2021. She is starting to get worried about taking the second dose of the vaccine if it is going to be like this and wants to ask about that. She received the first dose of the vaccine on 27Jan2021 at 13:30PM in the left arm. That night, Wednesday night she noticed the pain in her upper arm. She took Tylenol and then the morning it went away. Friday it came back and she took Tylenol again and it went away. But when she works or walks around there is pain again. Seriousness not provided. The event pain in her arm was assessed as recovering, other events recovered on 31Jan2021. Information on the lot/batch number has been requested.
74 2021-03-04 headache, cough, fever, fatigue 24 hours after vaccine given fever of 102 chills, loss of appetite body aches head ache cough loss ... Read more
24 hours after vaccine given fever of 102 chills, loss of appetite body aches head ache cough loss of taste and smell extreme tiredness. Lasting 8 days with cough still present. Took Tylenol, doctor did a Covid test with negative results. I had Covid 19 previously in November 2020 with same symptoms lasting 14 days
74 2021-03-04 headache 2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth... Read more
2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth day bad headache, indigestion and bad diarrhea. Injection site large red, purple, orange (size 2-1/2 " x 1-1/2" very sore. Today, 3/5; reaction site sore but brusing fading. Feel good. 1st Shot was slightly sore arm. Never had fever, cough, chills or vomitting. *** DID NOT CONTACT DOCTOR; WAS NOT EMERGENCY. Just felt like I had flu but thought I should report bad arm reaction.
74 2021-03-04 headache After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning,... Read more
After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning, itching, soreness and can't sleep on that side.
74 2021-03-04 headache After receiving her vaccine client stated that she has headache and dry throat. Vital signs obtaine... Read more
After receiving her vaccine client stated that she has headache and dry throat. Vital signs obtained by EMS BP 163/83, HR 79, O2 sat 96% Client states she feels better. Client discharged home by EMS.
74 2021-03-04 malaise, headache, fatigue Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and ... Read more
Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and then go away; Nauseous; No dizziness, but unsteadiness; Tired; Headaches; began to feel a little bad/ generally didn't feel well/Malaise; Feels like the stomach flu; Weak; Gentle muscle ache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration on 28Jan2021 15:30 in left arm at single dose as Covid vaccine, etanercept (ENBREL, 50 mL/mg, Solution for injection in pre-filled pen, lot number: 1119808, expiry date: Apr2023) via an unspecified route of administration from an unspecified date and ongoing at 1 DF weekly to the stomach area for rheumatoid arthritis, methylprednisolone (MEDROL, tablet) oral from an unspecified date and ongoing at 3 mg, daily (1.5 tablets daily for total of 3 mg) for rheumatoid arthritis, methotrexate (tablets) oral from an unspecified date and ongoing at 20 mg, weekly (2.5 mg tablets, 20 mg total) for rheumatoid arthritis. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity) and took levothyroxine, rheumatoid arthritis. She had had regular blood work for rheumatoid arthritis and that was normal for her, they were relatively normal and her ESR was down. No additional vaccines administered on same date of BNT162B2. No other vaccines given the same day or 4 weeks prior. The patient's concomitant medications included levothyroxine daily for endocrine abnormalities. It was a daily thing for the body and the body couldn't live without it if it did not have it. The patient previously took the Shingrix vaccine and it was terrible for her and put her into a rheumatoid arthritis flare and was taking prednisone and was getting better and the wap she was in a rheumatoid flare. No prior vaccinations received within 4 weeks prior to the first administration date of the suspect vaccine. The patient was taking 3 medicines for rheumatoid arthritis that might or might not affect the RNA in the vaccine. She wondered if etanercept would have an effect on the vaccine since it was shipped on ice overnight. She did not think they would affect anything. Nobody has said anything about the medications and she just wanted to get the vaccine. Her doctor knows nothing about the interactions and none of them seem to know if it is normal to have these symptoms 4 days after getting the vaccine. She felt great the first 2 days after getting the vaccine and then began to feel a little bad. She was having some symptoms maybe 4 days on 01Feb2021 after receiving the Covid vaccine and wanted to know if that was sort of normal. It was unusual for her, but she had nauseous, not dizziness, but unsteadiness, tired, also headaches and generally didn't feel well. She felt like she might have the stomach flu, but had not had that in so many years. She also felt weak. No temperature. Gentle muscle ache. On 01Feb2021 Monday night she had the nausea. On 02Feb2021 Tuesday, she had it again, and had it again today and almost threw up last night. Just the malaise or tiredness had gotten worse. She could not tell the difference between the rheumatoid arthritis, joint pain and muscle pain and this with the vaccine. She was having a few little odd pains, but nothing that she hadn't had before. It was more of a soft pain, they made her feel weak and then they went away. It was more muscle than joint. The events did not require a visit to emergency room or physician office. She was supposed to get a second dose but felt she shouldn't, it might put her back into a rheumatoid flare. She was just getting over it and afraid to go through that with the Covid vaccine also. The action taken in response to the events for etanercept, methylprednisolone and methotrexate was dose not changed. The outcome of events nausea, unsteadiness, tired (tired was reported as worsened), generally does not feel well, feels like the stomach flu, weak, few little odd pains; soft pain, joint pain was not recovered, of other events was unknown.
74 2021-03-04 chills, headache Felt like the flu that night & all the next day. Achey, painful joints, off-balance slightly, chill... Read more
Felt like the flu that night & all the next day. Achey, painful joints, off-balance slightly, chills, no fever that i know of, headache, extremely painful left arm up & down, into shoulder & scapula. . Stayed home all day., took Tyleno, benedril dye free the day after injection when feeling so bad
74 2021-03-04 headache Joint pain mild headache
74 2021-03-04 chills, headache headache, body aches and serve chills
74 2021-03-07 dehydration Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with na... Read more
Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with nausea, vomiting, and diarrhea for 3 days. Tested COVID 19 positive. Found to be hyponatremic. Was treated with IV fluids. Discharged on 3/6/21. Follow labs on 3/8/21.
74 2021-03-07 headache tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Head... Read more
tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Headache; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 74 years of age), via an unspecified route of administration in the arm on 01Feb2021 at a single dose for protection against COVID-19. She will be 75 in September, date of birth unknown. Medical history included cancer in which she doesn't know when was diagnosed but was supposed to be cancer free and hypertension. The patient's concomitant medications were not reported. The patient got to the ER last night (01Feb2021), she went to the health department to get the shot, then the ER. It was reported that last night, the patient was shaking like Parkinson's- she was cold, her tongue swelled, and she had a headache. The patient was not admitted. Shaking like Parkinson's, cold outcome: the patient felt better, she was a little quivery, but was given a steroid and IV last night, and her tongue was not swollen now. Headache: is still ongoing, but improving, she still has it. The outcome of tongue swelled was recovered on an unknown date; shaking like Parkinson's- she was cold and headache was recovering. Therapeutic measures were taken as a result of the events.
74 2021-03-09 malaise, fever Feeling sick/doesn't feel very well; hives (on neck and shoulder); Feverish; Achy; cannot move; This... Read more
Feeling sick/doesn't feel very well; hives (on neck and shoulder); Feverish; Achy; cannot move; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included "coronavirus" and allergies. The patient's concomitant medications were not reported. On an unspecified date, the patient was feeling sick and developed hives (on neck and shoulder). She wanted to know if she needs to get the second dose since she is afraid to have the side effects again. Patient was feeling feverish and achy, cannot move and doesn't feel very well on an unspecified date. She stated that the place where she received the vaccine had several sites set up. She got the first at one site. She is scheduled for her second dose at another site, but she read or heard it should be done at the same site. She wanted to know if it is safe to have the second shot. The outcome of the events was unknown. Information about lot/batch number has been requested.
74 2021-03-09 sweating her face flushed out; she got hot and sweaty; she got hot and sweaty; for three days following getti... Read more
her face flushed out; she got hot and sweaty; she got hot and sweaty; for three days following getting the vaccine, she felt like she had been punched in the arm; she is losing her voice; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL1283 and expiry date was unknown) via an unspecified route of administration, into left arm on 15Jan2021, as single dose for COVID Prevention. Medical history and concomitant medications were not reported. Patient stated that quickly after getting the vaccine, her face flushed out, and she got hot and sweaty. For three days following getting the vaccine, she felt like she had been punched in the arm, she was not just sore, but it felt like she had been punched. Stated that she was losing her voice. Patient received no other vaccines on the same day as the COVID vaccine. Patient wondering if other people are having the problem with the face flushing from the vaccine. Outcome of the events was unknown.
74 2021-03-14 chills, headache extreme joint pain; severe muscle pain; headache; chills; nausea; This is a spontaneous report from ... Read more
extreme joint pain; severe muscle pain; headache; chills; nausea; This is a spontaneous report from a non-contactable consumer. A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 03Feb2021 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis; osteoarthritis; and allergies to medications, food, or other products; all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam from an unknown date for osteoarthritis, which the patient had discontinued 2-3 days prior to immunization. The patient received the vaccine on 03Feb2021, the following day, 04Feb2021, the patient felt like she "got hit by a truck;" she complained of extreme joint pain, severe muscle pain, headache, chills and nausea. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The patient reported she gradually improved over the next 3-4 days and resolved. The clinical outcomes of extreme joint pain, severe muscle pain, headache, chills, and nausea were recovered in Feb2021. It was also reported the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
74 2021-03-14 fatigue, headache lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her fa... Read more
lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her face/incredible face pain, throbbing; slept most of the two days following the vaccine; face became bright red with swelling and intense in her cheeks and forehead; face became bright red with swelling and intense in her cheeks and forehead; disoriented; dizzy/wooziness; This is a spontaneous report from a contactable consumer herself. A 74-years-old female patient started to receive bnt162b2 (Pfizer-Biontech covid-19 vaccine, Solution for injection lot number: EN5318 and expiration date: unknown) intramuscularly from 29Jan2021 18:10 at single dose for prevent covid. Medical history included stroke from Apr2018 to an unknown date since she had a stroke 3 years ago. Concomitant medication included rivaroxaban (XARELTO) for stroke 30 mg, once a day. The patient previously took diphtheria vaccine. Caller states she spoke to safety agent and gave them all of her information. Caller states she received the first dose of the Pfizer COVID vaccine Friday at 6:15 pm. Caller states after waiting the recommended 15 minutes at the vaccination facility after receiving the first dose caller states four minutes later she began to experience lower jaw numbness that lasted a few seconds 29Jan2021. Caller states her face became bright red with swelling and intense in her cheeks and forehead In Jan2021. Caller states these symptoms were only in her face and no where else. Caller states she was taken back to the vaccination facility and the nurse monitored her every ten minutes for about 30 minutes until she cooled down and then she was sent home. Caller states during this time she was disoriented and dizzy In Jan2021. Caller states the next day she experienced pain in her face and to this day she still gets some pain but no more redness in her face. Caller states she is scheduled for the second dose on 19Feb2021. Caller states she read somewhere online that if you had a severe allergic reaction to the first dose you should not receive the second dose. She stated that within roughly five minutes of receiving the vaccine that she began to experience a numbing in the chin and the surrounding area. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She also experienced wooziness and a dizziness. She said the experience subsided in approximately 40 minutes of its onset. She is scheduled to receive the second dose on the 19th of Feb, but has some concerns about receiving it due to her experience. The patient had Fatigue, Headache in 29Jan2021. She clarifies her slight headache pain came back with the fatigue, reports it comes and goes. Her headache is off and on. After about 5 minutes of waiting she felt a little numbing in her jaw on the right side. Then 2 minutes later her face got bright, bright red, like there was real heat coming from it. She also had swelling in her face. It was very strange. She is asking if it is safe to get the second dose which is scheduled for 19Feb2021. This reaction lasted about 40 minutes. Her face was all flushed and burning hot red. It took a couple of hours for her face to come back to her normal color. After this faded, she reports she was left with incredible face pain, it was throbbing. She was extremely fatigued and is still fatigued, she can do very little. She is managing to cook. She slept most of the two days following the vaccine. The outcome of the events Numbness recovered on 29Jan2021,red face recovered in 2021, event pain in her face/incredible face pain, throbbing recovered in 31Jan2021, event Fatigue was recovering and other events unknown.
74 2021-03-14 headache, runny nose watery eyes; runny nose; slight headache; This is a spontaneous report from a contactable consumer. ... Read more
watery eyes; runny nose; slight headache; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 25Feb2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (BNT162B2) on 01Feb2021 for COVID-19 immunisation and she experienced she passed out and fell to the floor before daylight and dizziness on 01Feb2021. The patient experienced watery eyes, runny nose and slight headache in 2021. No treatment was received. No admission to hospital due to the events. The outcome of events was recovered in 2021, she was fine now. Information about lot/batch number has been requested.
74 2021-03-17 cough Patient brought back to chemo room for 1st dose of Pfizer BioNTech vaccine. LOT: ER2613 Man Exp: 07... Read more
Patient brought back to chemo room for 1st dose of Pfizer BioNTech vaccine. LOT: ER2613 Man Exp: 07/20/2021. Patient appeared anxious about receiving vaccine but was alert and oriented x4 and ambulatory with no other complaints. No previous reactions to vaccinations per patient. Patient received Covid vaccine at 1002, patient started coughing and complaining of chest tightness at 1005 with auditory wheezing. First Epi given at 1005 and O2 was placed on patient via face mask at 15L. 911 was then called. O2 saturations at beginning of reaction in the high 80's and dropping, HR 150's. Unable to obtain blood pressure throughout episode at clinic. IV access attempted and unsuccessful x1 at clinic. Saturations continued to drop into low 70's with no improvement of respiratory symptoms. Decision was made to give second Epi and was given at 1010. Before second attempt to establish IV access EMT arrived. Patient was transferred to stretcher and taken to Ambulance via EMS staff.
74 2021-03-18 chills, fatigue, headache, malaise, fever Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; ... Read more
Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; no appetite; Not feeling well; still tired; sleeping a lot; Very fearful of taking the second shot; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (Lot Number: EM0910) as single dose for covid-19 immunization. Medical history included mild chronic obstructive pulmonary disease, asthma, bronchitis, sinus infection and sulfa allergy from unknown dates. The patient previously took and experienced allergies to acetaminophen, montelukast sodium, hydroxyzine, budesonide-formoterol fumarate and pseudoephedrine hcl. On 09Feb2021, at 01:00, the patient experienced sore injection site with outcome of unknown; joint aches with outcome of unknown; chills with outcome of unknown; headache with outcome of unknown; nausea with outcome of unknown; vomiting with outcome of unknown; muscle pain with outcome of unknown; listless with outcome of not recovered; fever with outcome of unknown; no appetite with outcome of unknown; not feeling well with outcome of unknown; still tired with outcome of not recovered; sleeping a lot with outcome of not recovered; very fearful of taking the second shot with outcome of not recovered. No treatments were given for the events. Details were as follows: the adverse events included sore injection site, joint aches, chills, headache, nausea, vomiting, muscle pain, listless, fever, no appetite, not feeling well, all in that order. Worst side effects were gone by the third day; she was still tired, sleeping a lot and was listless. The patient was also very fearful of taking the second shot. The events resulted in doctor or other healthcare professional office or clinic visit on an unspecified date.
74 2021-03-18 fatigue Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breast... Read more
Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breasts are very sensitive and sore; Breasts are sensitive/Her breasts are very sensitive and sore; Swelling in her calves, her left and right arms; Swelling in her calves, her left and right arms/her hand was swollen, and her whole arm was like a log, it has been very uncomfortable; Her arm is very, very sore at the site of injection/Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; Her joints in her elbows, wrists, and ankles are hurting/lot of joint pain; Nauseous; lymph nodes were affected and swelling; Tired; Swelling everywhere; Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; uncomfortable; This is a spontaneous report from Social Media by a contactable consumer (patient). A female patient of 74-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via unspecified route of administration in right arm on 05Feb2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included chronic kidney disease from an unknown date in 2012. The concomitant medication was not reported. The patient stated that have not had any other recent vaccinations or started any new medications. The patient reported that on an unknown date Feb2021, soreness in arms, she has had swelling in her calves, her left and right arms. She said her arm is very, very sore at the site of injection, her breasts are very sensitive and sore, nauseous and later went away, had a lot of joint pain and swelling everywhere, her lymph nodes were affected and swelling, her right arm where vaccine was given her elbow was still swollen and sore below injection and also specified that swelling where arm is connected to elbow. It was also reported that hand was swollen, and her whole arm was like a log, it has been very uncomfortable on an unknown date in Feb2021. The patient has been tired on an unknown date in Feb2021 and patient worried about recovery of events. The patient stated that lymph nodes took 2-3 days, which started Sunday (as reported). It was reported that patient was still in sore, the breasts are super sensitive, which was weird. The patient also had strange shooting pains in her right arm that are shooting through it. The patient left arm was sore, but not as sore as her right. She said her knuckles were cracking when her hands move, and her right wrist was very sore but that was not so bad now. The patient stated that she thought these events were due to her good immune system. The joints were still sore, her elbows, all of the upper part of her body were also sore. The patient also reported that she was told older people don't have much reactions, but she certainly had. The patient had not seen doctor for the events. The patient took acetaminophen (LOT M045G, EXP Dec2023) as a treatment medication for the events. The outcome of the events nauseous was recovered on an unknown date in Feb2021, for the events swelling everywhere, uncomfortable, tired, lymph nodes were affected and swelling, breasts are sensitive/her breasts are very sensitive and sore was unknown while for rest of the events was not recovered
74 2021-03-18 fatigue, headache autoimmune disorder; Sjogrens disease; tired; Headache; Joint pain; throat felt like it was closing;... Read more
autoimmune disorder; Sjogrens disease; tired; Headache; Joint pain; throat felt like it was closing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9261, Expiration Date: May2021) via an unspecified route of administration in the right arm on 06Feb2021 (at the age of 74-year-old) as 0.3ml, single for COVID-19 immunisation. The patient relevant medical history included Lichen planus from an unknown date in Nov2020 and ongoing (get sores on her tongues and inside of her cheek and monitored by dentist every six months). The concomitant medication was not reported. On 06Feb2021, (Saturday) the patient experienced tired, headache, joint pain, states she also felt like her throat was closing. It was reported that she has been tested for sjogrens disease and the doctor stated she may have an autoimmune disorder on an unknown date. States her symptoms started several hours after the vaccine on the same day, states when she woke up the next morning, she felt fine. The patient stated that she had epi pen, wondered if when her throat felt like it was closing should she have used that. The outcome of the events autoimmune disorder, sjogrens disease was unknown while for other events tired, headache joint pain and throat felt like it was closing was recovered on 07Feb2021.
74 2021-03-18 fatigue, headache she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotte... Read more
she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249, Expiration date: May2021), via an unspecified route of administration in left arm 03Feb2021, at 10:50 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Prediabetes (5 years ago) and obviously overweight and had cat bite. The concomitant medication was not reported. The patient previously took historical vaccine, on an unknown date in Jan2021 (she got the first dose three weeks before on a Wednesday), first dose of bnt162b2 for COVID-19 immunisation and had no reaction. On 03Feb2021 (early evening) the patient experienced a bad headache and was very tired. Caller says where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that. She says she also had muscle aches and pains. The patient took Aspirin (UPC 9629513147, LOT: P115130, EXP: May 2021) for the event muscle aches and pains at a dose of 325mg, one before bed, took three during night total. The patient reported that she slept and slept and slept on an unknown date in Feb2021. It was reported that patient lots of bloodwork done over the years but if she eats correctly it goes away, then if she gets into the sugar, it comes back. The outcome of the events, where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that and she also slept and slept and slept was unknown while for other events was recovered on an unknown date in Feb2021.
74 2021-03-22 chills Caller is pt's wife, all information was obtained from caller. 74 year old male received 1st dose of... Read more
Caller is pt's wife, all information was obtained from caller. 74 year old male received 1st dose of Pfizer COVID-19 Vaccine Lot# EL8982 at location on 01/25/2021 @ 10:30. On 01/28/2021 pt started feeling chills, which resolved in 2-3 weeks. Pt started feeling back pain around 02/15/2021, went to Clinic around 02/17/2021 for the pain. The 2nd dose of Pfizer vaccine was due on 02/17/2021, pt had to cancel 2nd dose appointment due to Clinic appointment. Clinic staff told pt back pain was most likely due to a pinched nerve or lower back problems that comes with age. No x-rays or blood work was performed at Clinic. On 02/21/2021 pt stood up and felt even worse lower back pain, couldn't walk, pt went to ER and was admitted for 5 days, discharged 02/26/2021. Blood work was done and showed hyperkalemia, proteinuria, and kidney failure, upon discharge ER staff told pt to follow up with nephrologist. Nephrologist appointment is scheduled for 04/01/2021. Pt takes Morphine sulfate IR 15mg, Atenolol 50 mg, Fenosteride 5 mg, and Terazosin 10 mg. Pt has Myeloma, Hypertension, and Benign Prostatic Hyperplasia. Caller denies pt has any allergies. Pt will receive oncology treatment 03/29/2021, the oncologist alerted the caller the 2nd dose must be administered to the pt before oncologic treatment. Caller asked if the pt should get the second dose due to the kidney failure occurring after the 1st dose was administered. Currently pt is only experiencing lower back pain. Pt was advised that it is unlikely the vaccine caused kidney failure and the pt should get the second dose as soon as possible. SPI was consulted and Dr. was notified.
74 2021-03-22 fever High fever, general weakness leading to fall and hospitalization
74 2021-03-23 fever, headache, chills Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who present... Read more
Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who presents with acute onset early this a.m. nausea vomiting and change in mental status. History was obtained from the husband as patient is minimally responsive to verbal stimuli at this time. He states she was in her usual state of health until when she awoke this morning. Yesterday in usual state of health that she did have her 2nd COVID vaccine with the Pfizer variant. He states that day she was in her usual state of health with some mild arm pain on the left where she received the vaccine. This morning she awoke with a headache, fever, chills however was ambulating and conversing appropriately. She had no appreciable focal deficits at that time per the husband. She ate breakfast however she subsequently began vomiting. She progressed to a change in mental status with minimal responsiveness. She would say 1 or 2 words and that was it. They then presented emergency department. Diagnosed with severe sepsis, acute encephalopathy, acute meningitis, liver shock, autoimmune hepatitis, ascending cholangitis, acute pancreatitis.
74 2021-03-23 pneumonia admit 2/18, vaccine 1/9, 2/3. PNA, COVID+. Treated w/zinc, dexa, abx. DCd to home.
74 2021-03-24 malaise she had low pressure; she passed out at one point; She is very pale in her face.; lightheaded/Dizzy;... Read more
she had low pressure; she passed out at one point; She is very pale in her face.; lightheaded/Dizzy; She felt very bad the second day; She had an allergic reaction; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 09:45 (Batch/Lot Number: EL9262) as single dose for covid-19 immunization. Medical history included seizure (she had convulsions as a child). There were no concomitant medications. The patient experienced she passed out at one point on 03Mar2021, she had low pressure on 03Mar2021 at 08:00. The patient also experienced she is very pale in her face, lightheaded/dizzy, she felt very bad the second day and she had an allergic reaction on Mar2021. Reporter states She had an allergic reaction. The first day she felt fine, the second day she had low pressure and she passed out at one point and the rest of the day she had low blood pressure. She felt very bad the second day and Monday was the same and she is still feeling light headed and dizzy today. She says the first dose was given on the 05Feb2021 and her second dose she just had that on 02Mar2021 and that is the dose she is reporting about today. She says it was 03 Mar when she started having low blood pressure and passed out. She says she is still light headed and dizzy today, that is ongoing. She has not checked her blood pressure today but she feels like it is still low. She is very pale in her face. The patient underwent lab tests and procedures which included blood pressure measurement: low pressure on an unspecified date (she had low pressure). Outcome of she had low pressure and lightheaded/Dizzy was not recovered. Outcome of all the other events was unknown.
74 2021-03-28 malaise Covid vaccine monitoring documentation. Patient presented to ED 3/25/21 from home. Patient reported ... Read more
Covid vaccine monitoring documentation. Patient presented to ED 3/25/21 from home. Patient reported generally not feeling well x 1 week. Patient reported body aches, SOB, difficulty breathing. Daughter reported patient significantly got worse from prior night before arrival until patient woke up. Patient had contacted their PCP and was put on a Zpack which did not have improvement. Patient stated they received their second covid vaccine on 3/15/21, Pfizer EN6204. SARS-CoV-2 COVID-19 documented positive 03/25/21 16:14. Patient was admitted for monitoring/treatment. First covid vaccine received 2/22/21 Pfizer EN6198, second vaccine received 3/15/21 Pfizer EN6204. Patient received 2 doses but was not 14 days post second dose. SARS-CoV-2 COVID-19 documented positive 03/25/21.
74 2021-03-30 chills, throat irritation Chills; Irritation in throat; Swelling of tongue; Unable to swallow solids; This is a spontaneous re... Read more
Chills; Irritation in throat; Swelling of tongue; Unable to swallow solids; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), dose 2 via an unspecified route of administration, administered in the right arm on 25Feb2021 for covid-19 immunization. The patient's medical history was not reported; She takes other unspecified medications, though declined to provide details. The patient previously took BNT162B2 (Lot EM9809) on 04Feb2021 as first single dose for covid-19 immunization and hydrochlorothiazide and experienced anaphylactic reaction on an unspecified date (reported as years ago). The patient experienced the following medically significant events: irritation in throat on 27Feb2021 with outcome of recovered; swelling of tongue on 27Feb2021 with outcome of not recovered; unable to swallow solids on 27Feb2021 with outcome of not recovered; chills on an unspecified date with outcome of unknown. Details were as follows: the reporting nurse received both doses of the Covid-19 vaccine. She received the first dose on 04Feb2021. She received the second dose on 25Feb2021. 48 hours after the second dose she developed a really sore throat way down in the back of her throat. Her tongue also started swelling. She took diphenhydramine (ASSURED) 50mg. Her tongue was swollen the next day and she was unable to swallow solids. She went to a Covid clinic and was prescribed a diphenhydramine mouthwash. She was still unable to swallow. She has been taking diphenhydramine and Ibuprofen. It waxes and wanes. She had to take diphenhydramine to go to sleep. She thinks it is a reaction to the vaccine. She read about the ingredients and is not allergic to anything in the vaccine. She clarified that she did not have a sore throat. Her throat was irritated. It felt like pop rocks in the back of her throat. She saw a provider on 01Mar2021. She thinks her histamine level is too high. She also had chills last night, date unspecified. She had them once since 27Feb2021 and again last night. She was unable to confirm if they are ongoing or resolved. She had to turn up her electric blanket to 8. She was not shaking but just had chills. Years ago she had an anaphylactic reaction to hydrochlorothiazide. This felt similar to that. She was walking around fine and then started having swelling. She did not have difficulty breathing. She hoped it was not anaphylaxis. The diphenhydramine mouthwash was a compound of lidocaine, diphenhydramine and Maalox. The ratio was 1:1:1. The diphenhydramine 50 mg was a liquid children's allergy relief medication. Therapeutic measures were taken as a result of the events as aforementioned. Relatedness of drug to reaction for irritation in throat, swelling of tongue, unable to swallow solids and chills per primary source reporter of assessment was reported as related. The outcome of irritation in throat was recovered on 28Feb2021; the outcome of swelling of tongue and unable to swallow solids was not recovered; the outcome of chills was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of irritation in throat, swelling of tongue, unable to swallow solids due to temporal relationship and the known product safety profile. The clinical presentation is suggestive of a severe allergic reaction, involving the tongue and throat. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
74 2021-03-31 fatigue, headache a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the si... Read more
a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the side that she got the vaccine was cold; Second dose: pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2, dose 2, via intramuscular, administered in right arm on 16Mar2021 10:00 AM (Lot Number: EN6204; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included eczema from 2017, she had eczema all over her back and arms and had mild allergies to mold and juniper. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 at the age of 74-year-old on 23Feb2021 at 10:00AM (lot number: EN6198, Expiry: Jun2021) intramuscular injection in left arm and experienced pain at injection site and couldn't sleep. The patient also took Prolia shots for arthritis. The patient experienced headache, nausea, pain at injection site and hand on the side that she got the vaccine was cold on 16Mar2021, passed out, weakness and disorientation when walking on 17Mar2021, a little tired on 18Mar2021. The clinical course included: The patient was calling about the second vaccine that she got on 16Mar2021 (Tuesday). She was calling about the after effects. They were quite huge. She had a headache, nausea, weakness, and disorientation when walking. Stated she obviously had pain at the site of injection. Stated some of it was her own fault, and at first she felt fine. On the same day that she got her second dose of the covid vaccine, she had a glass of wine and was not too hungry. She ate a little that evening. The next morning she passed out. Clarified that she had two glasses of wine, not one. Caller's daughter was a doctor. Caller referd to her daughter as doctor daughter. Stated that she told her daughter about what happened. Her daughter told her it was because she was dehydrated. Her daughter told her that it was called vagus something or another. Her daughter was not there with the caller. Her daughter called it vagus something, she does not remember. Her daughter told her that it had to do with inflammation and her immune system. Caller stated she also has arthritis. Her daughter told her that she was stupid for drinking wine after receiving the second dose of the covid vaccine and not eating a full meal. Whenever she passed out and fell, she did not hurt herself but it was a wake up call. She realized she was vulnerable. She was calling because she did not know why no one told her to drink a lot of water after receiving the vaccine. She got a Prolia shot in July and the nurses told her to drink a lot of water. She was asking why the nurses who gave her the covid vaccine are not saying that to people. Her daughter told her to call the doctors office about this, and she told her daughter that it was over with now, she's 95%, she was a little tired on 18Mar2021. She was unconscious for 15 seconds per her husband. Her husband was shouting her name, and she did not hear anything. She wanted to call and report that the nurses should tell people to drink water. One more thing, her daughter told her that the covid vaccine was slowly released. About 10 hours after receiving the second dose of the covid vaccine her hand on the side that she got the vaccine was cold. She got the vaccine about 10AM, and about 10PM at night is whenever her hand got cold. She had pain at the injection site where she had the first dose of the vaccine too. She had more pain at injection site after the second dose of the vaccine. It was not awful, but only if she pressed on it. Clarified that she gets Prolia shots twice a year for her arthritis. Luckily whenever she started to get dizzy, she braced her self, whenever she fell, she did not fall from an upright position. She was crouched over, and fell against trays that fell with her. Her doctor daughter told her that inflammation was because of her immune system. One other thing was that she has been stung in the past and had extreme reactions from yellow jackets in the 90's. She thought her immune system was sensitive. One other things related to her autoimmune from 3 years ago. She moved to a city in 2012. Everyone told her after 5 years she would develop allergies. In 2017, she had eczema all over her back and arms. It was not just like a topical thing where she scratched and itched, it was under her skin. She went to a dermatologist and he took a biopsy, but the results just said eczema. She went to an allergist, he finally found a space on her underarms where he could do a test. The test showed that she had mild allergies to mold and juniper. Juniper is a tree that they have there, she has one in her back yard. Her allergy was very mild. She tried everything, and in 4 months it went away. Now she just latherers her skin with coconut oil. Her diagnosis that this autoimmune issue was related her immune response from the yellow jacket reaction is a self diagnosis. A doctor had never told her this, this was coming from her own self. Clarified that she is calling about the second dose of the pfizer covid 19 vaccine. Headache: It was not a bad headache, it was more like pressure all across the top. Whenever she went to sleep, the headache started. She got the second dose of the covid vaccine on 16Mar2021. She had a little bit of a headache this morning. A cup of coffee with milk made it better. Nausea: It started whenever she did not want to eat dinner. She could tell her stomach was not right. The nausea and headache started together about 12 hours after her vaccine at 10:00 PM. Weakness: She noticed weakness on the next day whenever she got up to use the bathroom. Clarified as the early morning of 17Mar2021. Her weakness was about 90 percent resolved. Disorientation when walking: Clarified that her disorientation was in reference to walking only right before she fell. She was not mentally disoriented. Mentally she knew that she was not doing well. Second dose: pain at injection site: The pain only lasted for about 2-3 hours. It was now absolutely minimal. She would have to press on it to feel anything. Her hand on the side that she got the vaccine was cold: She got the second dose of the covid vaccine around 10:00 AM, and noticed her hand was cold about 5:00 PM., about 7-8 hours later. Whenever she went to bed, she was cold. She thought that it resolved by the next morning. The morning after receiving the second dose of the covid vaccine, she passed out: She passed out about 8:15 AM. The outcome of the events headache, nausea, weakness, pain at injection site was recovering. The outcome of the events disorientation when walking and her hand on the side that she got the vaccine was cold was recovered on 17Mar2021. The outcome of the other events was unknown.
74 2021-04-01 headache, chills, dehydration, fever weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated p... Read more
weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated prior to this admit; shaking; chills; severe headache; right mid and low back pain; high fever up to 103 degrees; Not able to get out of bed except to get to nearby bathroom; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 74-years-old via an unspecified route of administration, administered in arm left on 05Mar2021 15:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included anal cancer (h/o anal cancers/p chemo & RT2013), hypertension, hypothyroidism and new fe deficiency anemia dx during this admit from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient has known allergies to Ampicillin, clindamycin, trilafon, imipramine. The patient reported that 4.5 days after 1st dose of Pfizer vaccine on morning of 10Mar2021 09:00, the patient woke up with shaking chills, severe headache, right mid and low back pain, high fever up to 103 degrees within 1/2 hr of onset and not able to get out of bed except to get to nearby bathroom to use toilet when needed. The patient took Tylenol 500 mg up to 5 doses by 10:00 am of 11Mar2021 when fever would not abate; the patient was weak and lightheaded on an unspecified date and since lived alone called a number to take her to ER. On an unspecified date, her blood pressure was low 80's to 90's over 40's to 50's all thru night and 1000 more mg of Tylenol was given at 4:00 am and fever then lowered to 99 or 100. Full infectious work up negative for bacterial sources including abdominal and pelvic cat scan, abdominal ultrasound, CXR, urine culture, she received 2 1/2 liters of IV fluid and IV Ceftriaxone and Flagyl in ER. In case bacterial cause which was not found including blood cultures, due to her BP still not improved by 5:00 am as she was dehydrated prior to this admit, she was admitted on medicine floor for 2 days. The patient underwent lab tests and procedures which included abdomen scan: unknown result on an unspecified date, blood pressure measurement: low 80's to 90's over 40's to 50's all thru night on an unspecified date; still not improved on an unspecified date, body temperature: high fever up to 103 degrees on 10Mar2021; 99 or 100 on an unspecified date, chest x-ray: unknown result on an unspecified date, culture urine: unknown result on an unspecified date, sars-cov-2 test: negative on 10Mar2021, ultrasound abdomen: unknown result on an unspecified date. Therapeutic measures were taken as a result of the events which included IV, fluids, 1 dose of 2 different IV antibiotics (Ceftriaxone and Flagyl) and Tylenol. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
74 2021-04-06 chills, dehydration, headache her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fl... Read more
her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fluids/I was so dehydrated; hadn't eaten anything; stated she started salivating and then threw up; stated she threw up once; she had a severe headache; she was shivering all evening and she couldn't get warm; she had body aches; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249, NDC number: Unknown, Expiration Date: May2021, Manufacturer: Unspecified) via an unspecified route of administration at right arm on 15Jan2021 at single dose for COVID-19 immunisation. Medical history of patient included knee pain and anxiety. Patient's concomitant medications included tramadol, paracetamol both 500 mg for knee pain and hydroxyzine hydrochloride (25mg tablet up to three times a day as needed by mouth, she does not take every day) for anxiety. On 15Jan2021 after vaccination patient experienced salivating and then threw up, stated she threw up once, severe headache, shivering all evening and she couldn't get warm, body aches, nausea, lost a lot of fluids/I was so dehydrated, hadn't eaten anything and her blood pressure was very low the next morning, she felt really weak on 16Jan2021. She required urgent care trip for IV fluids, "She was so dehydrated" and was "miserable" with her symptoms. She said she lost a lot of fluids and hadn't eaten anything. Patient wants to get the second COVID-19 vaccine dose because she is scheduled to have a knee replacement on 26Feb2021. She said she also had to deal with the pain in her knee, clarifying that is why she is getting a knee replacement. IV fluids (clarified as Saline), tylenol given as treatment. She reported when she got home she drank Pedialyte to try to rehydrate herself. She reported she went to urgent care on Saturday (16Jan2021), and by Monday 18Jan2021, she was feeling better, but she didn't golf on Tuesday, 19Jan2021. patient underwent lab tests and procedures which included blood pressure measurement which very low, influenza virus test and sars-cov-2 test was negative on 16Jan2021, blood test was fine. Patient said yes for investigation assessment. The outcome of event was recovered on 15Jan2021 for Increased salivation and Vomited and for all other event outcome was recovered on Jan2021.
74 2021-04-09 cough February 17, 2021: Patient received 1st dose of PfizerBioNTech vaccine. Reported mild cough, nause... Read more
February 17, 2021: Patient received 1st dose of PfizerBioNTech vaccine. Reported mild cough, nausea and bone pain lasting one week. However, she felt it wasn't severe enough to contact me as her asthma specialist. No cough per patient for the week prior to the second dose of PfizerBioNTech. March 10, 2021: Patient received 2nd dose of PfizerBioNTech vaccine at 1:10pm. Said she had mild chest tightness during the waiting period and used her Ventolin but she attributed it to the characteristics of the waiting room area. Between 5:00pm and 6:00pm (~4 hours later), she became light-headed, vomited and began to cough frequently. She contacted her primary care physician who told her to use Mucinex and contact me if needed. March 12, 2021: Patient contacted my office in the early afternoon. Unable to stop coughing while on telephone. Came to office approximately 90 minutes later. Physical Exam; Peak Flow 210 (personal best 310-320), oxygen saturation 93-95% (typically 97-98%), temp-98.2 F. Intractable cough with scattered bilateral expiratory wheezes on auscultation. Heart rate 132 and regular. Patient treated with Levalbuterol 1.25 mg nebulization with subsequent modest improvement in frequency of cough, pulse 102, oxygen saturation 96-97%. She declined going to emergency department of hospital because she did not want to get infected with COVID-19 from a patient in the waiting room. She declined Prednisone when told that the corticosteroid might reduce the efficacy of the 2nd dose of the vaccine. Placed on Budesonide 1 mg bid and Levalbuterol 1.25 mg q4-6h prn. March 16th: Patient reported her cough was 70% improved and wanted to stop Budesonide. Patient was told to continue Budesonide daily at 1 mg q day. April 5th: Patient contacted my office because of continued coughing and wheezing. Had been hospitalized March 25-27 for the cough.
74 2021-04-12 fatigue, headache Two days after receiving vaccine patient and family reports patient developed nausea and headache. s... Read more
Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report.
74 2021-04-13 cough Patient presented to the hospital for low hemoglobin, hematuria, abdominal pain, and cough. The pati... Read more
Patient presented to the hospital for low hemoglobin, hematuria, abdominal pain, and cough. The patient tested positive for COVID-19 upon admission to the hospital on 3/24/2021. CXR showed mild pulmonary vascular congestion. The patient was on 2L/min supplemental oxygen throughout admission.
74 2021-04-15 headache, fatigue, chills Strong Fatigue. Chills in fingers and toes, headache in back of neck, muscle pain in arms and should... Read more
Strong Fatigue. Chills in fingers and toes, headache in back of neck, muscle pain in arms and shoulder, soreness at injection site, slight vision impairment lasting 24 hours
74 2021-04-23 fatigue very tired; sleeping alot; dizzy spells; diarrhea; This is a spontaneous report from a contactable c... Read more
very tired; sleeping alot; dizzy spells; diarrhea; This is a spontaneous report from a contactable consumer. A 74-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 04Feb2021 13:30 (at the age of 74-years) as SINGLE DOSE in Arm Left for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included Lung cancer (lobectomy), copd, emphysema. The patient previously took Pcn (penicillin), codeine, morphine, Indocin and had drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. On 05Feb2021, the patient experienced very tired, sleeping alot, dizzy spells and diarrhea. The patient did not receive any treatment. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was not recovered.
74 2021-04-24 malaise, headache Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache ... Read more
Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache like migraine/chronic migraine; symptoms of a stroke; weakness on my right side from tongue to nose; weakness on my right side from tongue to nose; extreme nausea; general malaise; My shot arm feel like felt like I had been hit for several days; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) via an unspecified route of administration on 09Feb2021 at age of 74-year-old at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 19Jan2021 at age of 74-year-old for COVID-19 Immunization, the patient had no soreness or reaction until 10days later on 29Jan2021 when she had a low fever ~0.5-1 degree with chills and aches like a fever for 3 days, the patient experienced aches and pain; hurting all over on 29Jan2021, the patient took no medications, there were no further reaction. The second shot given on 09Feb2021, the patient's shot arm felt like she had been hit for several days beginning 10Feb2021. On 11Feb2021, the patient got a severe headache like migraine. Pain level 10/10. She had chronic migraine with all symptoms of a stroke (extreme nausea and weakness on her right side from tongue to nose, extreme headache about left side of the head). The headache on 11Feb2021 was overlap headache. On both sides of head and nausea. No other migraine symptoms. It lasted for 3 days. The patient was hospitalized due to the event(s) headache like my head was going to explode/severe headache like migraine/ chronic migraine. The patient took only butalbital, caffeine, paracetamol (FIORICET, 50, 325-40) from 11Feb2021 to 12Feb2021 at 40mg caff for several headache like migraine; promethazine (PHENERGAN) from 11Feb2021 to 12Feb2021 at 25mg for several nausea. The patient had several events general malaise where she didnot feel like doing her thing until today 30Mar2021. She had taken no medications or seen a doctor about it. The outcome of "headache like my head was going to explode/severe headache like migraine/pain level 10/10", "headache like migraine/chronic migraine" was recovered in 2021. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021145090 same patient, same drug, different event, different dose separated in times
74 2021-04-24 chills I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chill... Read more
I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 12:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included Thyroidectomy. Concomitant medications included pravastatin sodium (PRAVASTATIN SODIUM); levothyroxine sodium (SYNTHROID); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient received first dose of BNT162B2 on 27Feb2021 at 74-years-old for COVID-19 immunization: lot number=EN6203, lot unknown=False, administration date=27Feb2021, vaccine location=Left arm, dose number=1. On 22Mar2021 16:00, the patient fainted and hit her head. On 21Mar2021, the patient had stomach cramps, diarrhea and chills. I was wondering if passing out was an uncommon side effect. The outcome of the events was recovered. The patient received treatment for the events.
74 2021-04-26 headache chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness... Read more
chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness to my heart; She also had tenderness in muscle where site of vaccine was; headache; Left arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation (Age at vaccination 74 years) . Medical history included atrial fibrillation from 2019 (AFib was diagnosed a couple of months before Dec2019) , chronic obstructive pulmonary disease from Dec2019 , medical device implantation (Watchman device inserted), anaemia , oesophagogastroduodenoscopy , oesophageal stenosis, obesity. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) from Jul2019 to an unspecified stop date; metoprolol (METOPROLOL) taken for heart rate irregular from Nov2019 to an unspecified stop date. The patient previously took bnt162b2 for covid-19 immunisation on 06Jan2021. The patient also took aspirin (E.C.) and experienced haemorrhage. The patient experienced feeling occasional pain and tightness to my heart on 30Jan2021 with outcome of not recovered , chest pain on an unspecified date with outcome of not recovered , she also had tenderness in muscle where site of vaccine was on 28Jan2021 with outcome of recovering , headache on 28Jan2021 with outcome of recovering , left arm pain on 28Jan2021 with outcome of recovered. No follow-up attempts are possible. No further information is expected.
74 2021-04-26 fever, headache, chills troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her h... Read more
troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her head and her back; Chills; fever; She was shaking badly; Fainted; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 11:15 (Lot Number: ER8727; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 74 years). Medical history included ongoing rheumatoid arthritis, melanoma, depression, heart attack (had a heart attack 7 or 8 years ago) and covid (covid in the first week of January). Concomitant medications included levothyroxine sodium (SYNTHROID) and escitalopram oxalate (LEXAPRO) for depression. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for covid-19 immunisation and experienced rash with itching and a lump and swelling (74 years). The patient fainted on 24Mar2021, chills and fever on 24Mar2021 20:00, pain on the back of her head and her back and a couple of places like anyone would get when they fall on 25Mar2021 and she was shaking badly on 24Mar2021. The patient underwent lab tests and procedures which included blood work: unknown results and troponin: high troponin levels on an unspecified date. Therapeutic measures were taken as a result of tremor included Aleve. Outcome of the events chills and pyrexia was recovered on 25Mar2021 (four hours) while outcome of the events head pain and back pain was recovering. Outcome of the remaining events was unknown.
75 2021-01-01 chills, fever Fever, chills, nausea beginning about 6 hours after the vaccination and continuing for about 36 hour... Read more
Fever, chills, nausea beginning about 6 hours after the vaccination and continuing for about 36 hours
75 2021-01-04 throat irritation, throat pain DAY AFTER VACCINATION, DEVELOPED SORE/SCRATCHY THROAT
75 2021-01-09 chills, fever Pfizer-BioNTech COVID-19 Vaccine 1st and 2nd day had side effect of chills for a couple hours each ... Read more
Pfizer-BioNTech COVID-19 Vaccine 1st and 2nd day had side effect of chills for a couple hours each day and low grade fever the 2nd day. No side effects the 3rd day.
75 2021-01-10 chills Extreme pain in bone, not muscle, of left arm started approximately 30 minutes after injection. 4 ... Read more
Extreme pain in bone, not muscle, of left arm started approximately 30 minutes after injection. 4 hours later chills started . Both symptoms continue 12 days later.
75 2021-01-10 fatigue Mild arm soreness at site the following day Significant fatigue on the following five days and now ... Read more
Mild arm soreness at site the following day Significant fatigue on the following five days and now Heart palpitations and elevated BP on day four Mild nausea on day five
75 2021-01-13 malaise after 6 hrs injection of 2nd dose, left arm was swollen felt tender. That night, I feel chilled; n... Read more
after 6 hrs injection of 2nd dose, left arm was swollen felt tender. That night, I feel chilled; not feeling very good. Next day same prblem especially chilled; went to bed under blanket to warm up Its now 12:36 next day, no improvement
75 2021-01-14 fatigue feeling fatigue; "just not herself, out of whack in her body"; diarrhea; This is a spontaneous repor... Read more
feeling fatigue; "just not herself, out of whack in her body"; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she received the Covid 19 vaccine on 07Jan2021 then the day after (08Jan2021), she began feeling fatigue, "just not herself, out of whack in her body", and diarrhea. The patient reported that she was fine now. She inquired if those were normal. The outcome of the events was recovered on Jan2021. Information on the lot/batch number has been requested.
75 2021-01-15 headache Soreness at injection site, mild headache
75 2021-01-17 headache altered taste; altered sense of smell; slight left arm soreness; slight headache; This is a spontane... Read more
altered taste; altered sense of smell; slight left arm soreness; slight headache; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 and expiration date not provided), via an unspecified route of administration left arm first dose on 08Jan2021 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. It was reported that patient got the first shot of the Pfizer Covid 19 vaccine last Friday 08Jan2021. Stated that she had normal slight arm soreness and slight headache on Saturday 09Jan2021. Stated that she woke up this morning 11Jan2021 and had altered taste and sense of smell. Stated that she has not heard of this as reaction to the shot. Stated that she feels fine. Stated that she put on perfume that was old and fixed grits with cheese which she could barely taste. Stated that she tried other things and noticed that she has altered sense of taste and smell. The patient did not received treatments for the events. The outcome of the events slight left arm soreness and slight headache was recovered on 09Jan2021 and not recovered for the other events.
75 2021-01-18 dehydration, chills Chills, nausea, vomiting , diarrhea Then all day. Very ?deep? sleep. Then extreme dehydration. So ... Read more
Chills, nausea, vomiting , diarrhea Then all day. Very ?deep? sleep. Then extreme dehydration. So to ER for fluids. Don?t know how to go back. Original start of the event date was 01/14/2021. In am
75 2021-01-18 headache, fatigue injection site pain, very tired kept falling asleep, headache, bad muscle and joint pain, feeling un... Read more
injection site pain, very tired kept falling asleep, headache, bad muscle and joint pain, feeling unwell and wanting to sleep all day
75 2021-01-19 throat irritation Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbea... Read more
Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbeat and because of her previous history of reaction to chemicals she became anxious. Pt further evaluated by NP and pt c/o itching to back of throat. No SOB. At time of NP evaluation heart rate within normal limit, 84. Alert and oriented. No acute distress. Pt very anxious. Pt monitored for one hour with no issues or emergent care needed.
75 2021-01-20 headache 5 min post injection angioedema s begin; flushing, flushing to genital area, progressed to GI, throa... Read more
5 min post injection angioedema s begin; flushing, flushing to genital area, progressed to GI, throat, HA, B/P170 (never this high); eyesight blurred. Systemic w/o urticaria
75 2021-01-20 headache Severe headache; Nausea; Throwing up; I got so sick; Body ache; I was in pain everywhere; This is a ... Read more
Severe headache; Nausea; Throwing up; I got so sick; Body ache; I was in pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK5730), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunisation. Medical history included migraine, depression, AFib, COVID-19 in Jun2020, and sleep disorder. Concomitant medications included prednisolone, ciprofloxacin, warfarin, timolol, sleep medications (unspecified), and eye drop (unspecified). The patient experienced body ache; stated that she was in pain everywhere on ; severe headache, nausea, throwing up, The patient stated that she felt like she had COVID all over again. She got so sick. It was reported that she worked for a clinic (also reported as a hospital) and on Friday (08Jan2021), she got the COVID shot. By Friday evening, she had body ache, and by Saturday, she was in pain everywhere. She also had severe headache, nausea, and was throwing up on 09Jan2021. According to her, the whole thing felt like she had COVID all over again and this went on through yesterday, she still had the headache today and some nausea. She stated that they were supposed to report this. When further clarified, the patient stated that she was tested yesterday again, just because it felt like COVID and because she had COVID way back in June last year. Stated that it felt like that all over again. She went to the [unclear statement], after hours to urgent care yesterday, they tested her again for COVID. She did not have COVID, she was clear, she was negative for COVID. Stated that she now knows that's what she has was just a result to the shot. When probed to clarify if it was the first dose or the second dose, the patient stated that she was just calling to ask. According to her, she was due to have it, the 29 (not clarified). She doesn't know if she should do it, she got so sick, she had been throwing up and everything. The patient was inquiring if she should do the second dose. The patient stated that she was about 150 lbs. and she does get her INR checked. As treatment, the patient took Tylenol and then took Zofran for the nausea. Outcome of the events 'Severe headache' and 'Nausea' was not recovered, while for the other events was unknown.
75 2021-01-21 headache During monitoring period post vaccine, pt experienced 8/10 head pain. Emergency services was called ... Read more
During monitoring period post vaccine, pt experienced 8/10 head pain. Emergency services was called and arrived onsite for assistance. Vital signs taken by Nurse when I arrived onsite.
75 2021-01-21 malaise Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe B... Read more
Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe BP, but never had that happen before. I was anxious as I have anxiety disorder! But my face was RED and TIRED looking. I asked staff what wrong. No swelling at that time! 4:40 PM. That nite, my heart started POUNDING HARD all night, not stop. Ativan not help. I slept, weird dreams, wake up and still heart pounding. 8 am --- got up and hands, arms, extremities SWOLLEN!! Heart still pounding, Felt like allergic to MSG or nitrates or preservatives or too much salt. Felt weird.. Not faint-- just weird. Tired from the pounding heart. Not fatigued. I did have sore arm, but it was NOT an issue. My hands, toes were red.
75 2021-01-21 headache Minor headache, stomachache, resolved in less than 30 minutes. Vital signs measured, blood pressure ... Read more
Minor headache, stomachache, resolved in less than 30 minutes. Vital signs measured, blood pressure 163/117, repeat in 15 minutes without intervention on a different blood pressure measuring device was 150/87.
75 2021-01-21 cough On observation after vaccine, patient reported swelling in her mouth and lips. Patient took 2 benad... Read more
On observation after vaccine, patient reported swelling in her mouth and lips. Patient took 2 benadryl 25mg and stated she felt better. Advised patient to go to ER and patient refused. Asked patient to stay for extended observation. About 30 min later, patient stated she was coughing and feeling slight tightness in her chest. At this point, patient was agreeable to go to the ER and patient was taken.
75 2021-01-22 chills, fatigue, headache 01/15 Evening of injection developed headache; took 1 Aleve at 9:30 pm. Went to bed at 10:00 pm an... Read more
01/15 Evening of injection developed headache; took 1 Aleve at 9:30 pm. Went to bed at 10:00 pm and woke at 3:00 am on 1/16 with headache and nausea. At 7:00 am and all day remained in bed with headache, nausea (unable to eat or drink until evening when I had water, 1 scrambled egg and 1 piece of toast), fatigue. My arm was mildly sore at injection site. On 1/17 nausea, chills resolved. Headache better. Fatigue better but remained for about 3 days.
75 2021-01-24 fatigue 1/16/21 - left arm pain, tired 1/17/21 -fever blister on lower lip 1/19/21 - pain at Rt upper gum , ... Read more
1/16/21 - left arm pain, tired 1/17/21 -fever blister on lower lip 1/19/21 - pain at Rt upper gum , lesion on gum
75 2021-01-24 headache During monitoring period post Pfizer COVID-19 vaccine, patient significant head pain with decline vi... Read more
During monitoring period post Pfizer COVID-19 vaccine, patient significant head pain with decline vital signs. Emergency services was called and arrived onsite for assistance. Patient monitored and refused to transfer to ER.
75 2021-01-24 headache, fatigue I began feeling deeply fatigued and achy about six hours after the vaccination and went to bed. The... Read more
I began feeling deeply fatigued and achy about six hours after the vaccination and went to bed. The aches and fatigue continued the next day and evening and, additionally, I had a swelling in my left wrist of the arm that I had the shot in. That swelling was painful; it was about an inch across and looked like it contained fluid. All those symptoms continued for two more days and then the swelling began to subside and is now gone.. Today, the morning of the fifth day after the vaccination, I awoke at 3 a.m. with severe body aches, took two Tylenol and eventually was able to sleep again. I am feeling better but very, very tired and have some bodyaches and headache but not as severe.
75 2021-01-24 fatigue I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left... Read more
I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left arm, I couldn't sleep on my left arm due to this soreness. This started the day the soreness started. The following day and up till now I felt very tired and like I needed to take a nap. Due to work I have not been able to nap. On Sunday I noticed I had a fever blister on the right side of face, under my lip by my chin. It looked like a herpes blister. I rarely get them unless there is a serious stressor to my body or if my body is emotionally stressed. Valacyclozir I took 4 of those in the morning and 4 tablets in the evening after noticing them. I put a cream on the blister. On Tuesday or Wednesday 3 or 4 days after the vaccine I felt a pain in my gum by back two teeth, the gums were very painful when I brushed my teeth or put my tongue on it. I went to the dentist Friday the 22nd, however the dentist said it was intraoral herpes that he believes it is looked to the vaccine. Dr. believes the COVID vaccine activated the dormant herpes in my system . He said says it is located over the Greater Palatine Foramen. The herpes on my chin went away. I still feel light sensitivity and fatigued. Dr recommended to see my dermatologist. Either the 22nd or 23rd I had a virutal appointment with my dermatologist. She recommended I take 4 Valacyclozir in the AM and PM. And then 1 day for 10 days. Both doctors recommended not getting the 2nd dose until the herpes vaccine goes away. Once it goes away they suggested taking the Valacyclozir before taking the 2nd dose. I am still not feeling normal. My dentist said he was going to consult a group of dentists to see if any other dentists have seen the correlation between the COVID vaccine and activating the herpes virus. I plan to consult my PCP about if I should delay the 2nd dose.
75 2021-01-24 influenza like illness Woke Sunday January 24 with flu like symptoms
75 2021-01-24 headache, fatigue headache,nausea,diarrhea,arm swelling. fatigue
75 2021-01-25 headache C/O tongue feeling thick, feels hot and has headache. Given Benadryl 50 mg IM RDM and Epinephrine (... Read more
C/O tongue feeling thick, feels hot and has headache. Given Benadryl 50 mg IM RDM and Epinephrine (1:1000 aq) 0.5ml). No improvement and transported via ambulance to ER. Contacted by RN later and reports treated and released at ER.
75 2021-01-25 cough, body temperature increased, chills, fatigue, headache Elevated temperature of 100, chills, joint pain, non productive cough, mild headache, exhaustion.
75 2021-01-26 chills About 24-26 hours after the vaccine, I had chills for about 3 hours. Vaccine was on Monday, 1/25, C... Read more
About 24-26 hours after the vaccine, I had chills for about 3 hours. Vaccine was on Monday, 1/25, Chills on Tuesday, 1/26
75 2021-01-26 throat irritation Progress Notes 1/26/2021 Patient: ... Read more
Progress Notes 1/26/2021 Patient: Date: 1/26/2021 a 75 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience scratchy throat. She denied difficulty breathing, difficulty swallowing and throat tightness. This provider was notified of patient reaction and she was then assessed in the emergency bay area. ALLERGY REVIEW OF SYSTEMS: Patient denies facial swelling, chest tightness, shortness of breath, wheezing and dizziness Previous Reactions: Patient reports a history of previous reaction after receiving an allergy shot many years ago. She is unsure of entire course of events but states she did need medical treatment including a shot. Objective Vitals Vitals: 01/26/21 1412 01/26/21 1439 BP: 135/78 137/63 BP Location: Right arm Patient Position: Sitting Pulse: 90 80 SpO2: 95% 98% Blood Sugar 88 collected at 1415 Physical Exam Vitals signs and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: She is well-developed. She is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Pharynx: Oropharynx is clear. No pharyngeal swelling or oropharyngeal exudate. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No tachypnea or respiratory distress. Breath sounds: Normal breath sounds and air entry. No stridor or decreased air movement. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert and oriented to person, place, and time. Gait: Gait (with cane assist) normal. Psychiatric: Speech: Speech normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy. Patient was observed for 65 minutes s/p injection. She states only symptom of itchy throat improved. Patient accompanied to building exit . Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash)
75 2021-01-27 fatigue, chills, sweating, malaise Dizziness; history included compromised immune status; history included compromised immune status; g... Read more
Dizziness; history included compromised immune status; history included compromised immune status; getting really tired/fatigue; Gets real sweaty; chills; almost passed out at doctor's office; Nausea; Felt cold; Blood in urine; Feeling unwell; Feeling bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686), intramuscular in the left upper arm on 08Jan2021 at 15:45 at 0.3 mL, single for COVID-19 immunization. Medical history included Leighten Plantar Alopecia (hair follicle is an enemy), skin infection (infection in body most of the time, at least on skin), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity, autoimmune disorder (diagnosed 8 months ago). She has lost some height, prior to taking the vaccine and she said it was related to age. There were no concomitant medications. The patient experienced feeling unwell on 10Jan2021; blood in urine on 10Jan2021 at 17:00; nausea at 10:00, chills at 11:00, almost passed out at doctor's office at 10:00, felt cold - all on 11Jan2021; getting really tired/fatigue on 14Jan2021 at 09:30; gets really sweaty on 13Jan2021 at 10:00; and dizziness on unknown date. The patient had the first shot on Friday (08Jan2021). On Sunday (10Jan2021), she started feeling bad. She was feeling good about getting it and had no reaction. She has an autoimmune disorder that made her a little afraid to take, but with all the indications, they said it would be much better for her to take it than to get the COVID virus. Sunday (10Jan2021), she does not feel good. So, she started having blood in urine. She thought she had a UTI and had not had one in 20 years. It felt like that is what she had and with the blood in urine. She just took Tylenol and waited until Monday morning because she does not like sitting in doctor's office. They gave her a cup to give sample and said she didn't need to see provider. They will have it checked and in the meantime call in a prescription. It kept getting worse and worse. She was about to passed out in the doctor's office on 11Jan2021, she got nauseous and almost threw up. She got in the car with her husband and he was trying to get her home. She got chills and got so cold and could not warm her body up. Her husband gave her Phenergan and it kind of knocked her out for a while to ease her nausea. She was thinking of going later today (14Jan2021), when she gets enough energy, to get a COVID test. She does not know if it will give false positive or not. She had chills and now she gets sweaty since 13Jan2021. She took her temperature and she did not have one. She just now got up. It is 10:00. She got up this morning (14Jan2021) and was really tired. She was not sweating this morning. Tiredness is kind of new, and when she talked to the nurse, she sort of felt like maybe it was a reaction to the COVID vaccine, but then she talked to her daughter and she said the symptoms she was having are usually symptoms that occur with second dose of the vaccine. It is not uncommon for people to have symptoms she was having. She wanted to know if she should have a COVID test. If she has had just one shot, would the test give a false positive coming from the COVID. They were asking if patient should take the second dose, and should she continue her UTI medication. Doctor's visit to give urine sample on 11Jan2021 (results: negative for UTI). She did not see a doctor though. They sent sample and prescribed a sulfa based medication for a UTI. She did start feeling a little better and stopped having blood in her urine. She plans to continue it because she does not like to stop taking an antibiotic. She did not have any clue that it was not a UTI until the nurse from her provider's office called to tell her results of urine sample was negative. Outcome of event getting really tired/fatigue was not recovered; events almost passed out at doctor's office, blood in urine, chills, and gets really sweaty was recovering; and unknown for other events.
75 2021-01-27 fever muscle and joint very sore; muscle and joint very sore; arm shoulder swollen (still on swollen after... Read more
muscle and joint very sore; muscle and joint very sore; arm shoulder swollen (still on swollen after 3rd day); Fever; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL8982 via an unspecified route of administration on 15Jan2021 10:00 at SINGLE DOSE for covid-19 immunisation. Vaccine location= Left arm, dose number= 1 Medical history included hypertension, blood cholesterol increased, overweight, back pain, hip arthroplasty, spinal operation. Concomitant medication included estradiol (ESTRACE), triamterene (TRIAMTERENE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), melatonin (MELATONIN). The patient previously took dilaudid and experienced drug hypersensitivity. On 16Jan2021 01:00 patient experienced muscle and joint very sore, arm shoulder swollen (still on swollen after 3rd day), fever, all with outcome of recovering. The action taken was not applicable.
75 2021-01-28 throat pain I noticed that same afternoon one side of my mouth/throat was sore, in the back on the left. I tried... Read more
I noticed that same afternoon one side of my mouth/throat was sore, in the back on the left. I tried gargling with salt water, then later with baking soda in water. Ate some yoghurt later. No real difference. Today (next day) I see white blotches on side of tongue in back. I feel fine other than this, no other adverse reactions. Hurts....bothersome still in the back of my throat when talking or eating.
75 2021-01-28 fever, chills Low grade fever; Chills; Rash; This is a spontaneous report from a contactable healthcare profession... Read more
Low grade fever; Chills; Rash; This is a spontaneous report from a contactable healthcare professional. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included urinary tract infection (UTI). Patient stated she was on an antibiotic for a UTI before having the vaccine. No other vaccine in four weeks. No COVID prior vaccination. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Patient stated that she broke out with a rash across chest and legs approximately 24 hours (on 11Jan2021) after having the vaccine. Patient states she had a low grade fever and chills 4 days post covid-19 vaccination (on 14Jan2021). The events resulted in doctor or other healthcare professional office/clinic visit The patient received treatment for the events. The patient was given a steroid shot by dermatologist. Patient was tested for COVID test post vaccination (covid test type: Nasal Swab) which showed negative result. The outcome of the events was not recovered. Information on the batch/lot number has been requested.
75 2021-01-28 fatigue, chills, fever, headache Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chil... Read more
Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chills for 3 nights fever range from 100 degrees up to 103.8, had nauseau and vomited one day, my face- looked a little swollen and cheeks were pink, was in bed mostly for 13 days. Called My Doctor after about 4 days , he prescribed MethyIIPredisolone 4 mg tablets, seems to bring fever down and stop chills, still feeling really bad, went to Urgent Care and they did Covid Test which was Negative, had virtual call with their doctor , and they prescribed a "Z Pak" Did not stated feeling better until 13 day. When taking Predisone, I started having chest pains, when I only had 4 more pills to take. Had to take 2 Nitro and discontinued Predisone. Still weak and tired.
75 2021-01-29 fatigue, chills 4:30 - 6:30 pm on 1/29/2021 nausea, chills, dry heaved, bowel purge (not diarrhea) No treatment -sle... Read more
4:30 - 6:30 pm on 1/29/2021 nausea, chills, dry heaved, bowel purge (not diarrhea) No treatment -slept Fine after this event but tired
75 2021-01-30 chills Pfizer-BioNTech COVID-19 Vaccine EUA. Adverse events: chills, joint and muscle pain, nausea and vomi... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Adverse events: chills, joint and muscle pain, nausea and vomiting. Events decreasing after one day.
75 2021-01-31 chills, fever Chills, nausea, fever(102) Saturday except for temperature of 100 all symptoms were gone.
75 2021-01-31 chills, fatigue, headache rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak... Read more
rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak to walk further than the bathroom; This is a spontaneous report from a contactable other hcp. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 09Jan2021 13:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included benazepril (BENAZEPRIL), diltiazem (DILTIAZEM), rivaroxaban (XARELTO) and estrogen/methyl te. The patient previously had the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020. The patient stated, "I woke from sleep about 12 hours later (10Jan2021) with rigors, muscle aches, head ache and pain in my inner ears as well as photophobia and feeling of exhaustion. The rigors had resolved by 8am but other symptoms persisted. I was too weak to walk further than the bathroom. I was able to consume only warm liquids, although I had no nausea, vomiting or diarrhea. Note that since onset post infectious irritable bowel symptoms in February after visiting a city, weeks before the pandemic was recognized, I have had very abnormal but not absent sense of taste and smell, making me wonder whether I was infected in February without the usual symptoms." The patient recovered from rigors on 10Jan2021, outcome of the event weakness was unknown while other events were not recovered.
75 2021-02-02 sleepiness Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures... Read more
Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest.
75 2021-02-03 chills Flu like symptons, aches, weakness,chills
75 2021-02-04 fever severe arm pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 75-yea... Read more
severe arm pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 09:45 at single dose for Covid-19 immunization. Medical history included high blood pressure; thyroid disease; high cholesterol; prior stroke; prior to vaccination, the patient was diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced severe arm pain and fever on 20Jan2021 14:30. No treatment received for the adverse events. This is a non-serious report. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021.
75 2021-02-04 chills, fatigue, fever severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tirednes... Read more
severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a "D", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a "B" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.
75 2021-02-05 chills, fever Dizzy, light-headed, unable to balance, fever, lack of appetite, chills, slight nausea for about 36 ... Read more
Dizzy, light-headed, unable to balance, fever, lack of appetite, chills, slight nausea for about 36 hours Tylenol 2x500mg
75 2021-02-05 headache, malaise, sweating, chills, body temperature increased I woke up feeling sick with headache and pain in abdomen, went to bathroom and sat down, I was burni... Read more
I woke up feeling sick with headache and pain in abdomen, went to bathroom and sat down, I was burning up and perspiration was dripping down my body, i felt like i might throw up and that was the last though until I came to on the floor of our walk in shower. It took me a while to orient myself and get up and sat down again on toilet still with pain in head and disoriented. next thing i know i am coming to wedged between the toilet tank and the vanity. I managed to get back on the toilet and sat there wondering what was happening to me. I could tell i was getting better so i just sat there a while longer until i though my legs would hold me so i could get back to the bed. I laid in bed the rest of the night unable to sleep with headache and shivering with being cold even under my blankets. I stayed in bed Saturday then called the doctor first thing Monday morning. I got in to see her at 10:30 Monday morning. She ordered a full blood panel and urinalysis and heart monitor for 48 hours. The blood panel and urinalysis reports are all ok. Have not received report yet from the heart monitor. Doc said I cannot take the second shot.
75 2021-02-07 sweating, malaise, headache At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left side... Read more
At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left sided neck pain, flush, and sudden left sided headache. Staff was notified EMS crew immediately. B/P 151/83, Also diapheretic. Patient reported not feeling well at all and would like to go to the hospital. Transported to local hospital. for evaluation
75 2021-02-07 cough Lightheaded, cough, mild wheeze that responded to albuterol Dizziness
75 2021-02-07 productive cough Went to ER on 2/5 with Shortness of breath and productive cough since first vaccine given. Diagnosed... Read more
Went to ER on 2/5 with Shortness of breath and productive cough since first vaccine given. Diagnosed with hypoxemia, and COVID pneumonia. Admitted to hospital
75 2021-02-07 headache accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; ... Read more
accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit. Information on the lot/batch number has been requested.
75 2021-02-09 fatigue 75-year-old woman who presented to the emergency room 2 days after vaccination with chest tightness,... Read more
75-year-old woman who presented to the emergency room 2 days after vaccination with chest tightness, fatigue and was found to have pericardial effusion without tamponade. It was noted that patient has had intermittent syncope since August of 2020 and clinical interpretation is likely that pericardial effusion pre dated vaccination. In her workup for dizziness and syncope she had not previously undergone EKG, chest x-ray or echocardiogram therefore pericardial effusion could have been missed. I elected to report the pericardial effusion to be on the side of caution.
75 2021-02-09 fatigue Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer. A 7... Read more
Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer. A 75-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), intramuscular on 02Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was calling about the Covid-19 vaccine and reported that she had the 2 shots. She said that after both shots, her arm hurt, she felt wiped out, and she had joint pain. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The patient said that after the first vaccine, she had not had knee surgery, but before the second the second vaccine she had knee surgery. The patient clarified that it was a knee replacement on 12Jan2021. The outcome of the events was unknown.
75 2021-02-09 body temperature increased, headache Slight headache; joints aching mild; temperature -100.2
75 2021-02-09 fever, fatigue felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a cont... Read more
felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) intramuscular, on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 75 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) received on 02Jan2021 at single dose. Relevant medical history included COVID-19 last Mar2020 and knee replacement on 12Jan2021. The patient received no concomitant medications. The patient reported she had the 2 shots. After both shots, her arm hurt, she felt wiped out, and she had joint pain. After the second shot, she did run a fever as high as 100. She said that she had the second shot on Friday 22Jan2021 and on Saturday she was wiped out. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The event wiped out had resolved in Jan2021, while outcome of other events was unknown.
75 2021-02-09 fever, chills really bad chills; fever; joint pain; soreness/achiness; she was really stiff and she could not walk... Read more
really bad chills; fever; joint pain; soreness/achiness; she was really stiff and she could not walk real good; she was really stiff and she could not walk real good; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247, expiration date May2021), intramuscularly on right arm on 23Jan2021 10:50 at 0.3 mL single for COVID-19 immunization. Medical history included ongoing arthritis, right knee replacement from Aug2019 to an unknown date, ongoing high blood pressure, a long list of antibiotics that she was allergic to/certain types of mycin, allergic to penicillin, covid-19 from 23Dec2020 to an unknown date. Concomitant medications included unspecified a lot of medications. The patient previously took flu vaccine in 2020 for immunization, codeine and experienced drug allergy (she cannot take codeine), norvasc and experienced drug allergy (certain types of mycin, several types of blood pressure medication like norvasc). The patient woke up early at 6:00am on 24Jan2021 with really bad chills, fever and joint pain. Her temperature was 101.6 after taking Tylenol. Her arm felt like there was a small "know" in it. Some soreness, but feeling better. The patient had a really bad day yesterday on 24Jan2021, she experienced really hard chills about 5 or 6 episodes of chills. Her temperature got up to 101.6 and that was with Tylenol. She felt better today and her temperature was back to normal on 25Jan2021. She had soreness, achiness, she was still sore in regards to her muscle. She got over covid. She was diagnosed with covid on 23Dec2020, about 30 days ago. She got the first dose of the vaccine on 23Jan2021 and she was scheduled then since she was told to wait about 30 days after being diagnosed with COVID. She heard the second shot might be more intense and asks if that was right. She called the doctor. When querying lot number, she put her glasses back on to read the stamp on the card. She had to get under the lamp since it was kind of blurry. She could not read the lot number on the card and had to get a magnifying glass and then was able to provide lot. The first episode of chills happened during the night and woke her up about 6 am on 24Jan2021, when she got up she was really stiff and she could not walk real good. She had to hold on to something when she got up to go to the bathroom. The chills that were so bad were yesterday from 11 till about 4 or 5. Around 6 or 7 pm yesterday she had lighter chills. She got real red in the face since she was hot and her temperature was going up. Reported she took Tylenol earlier than she should have taken it since it was scaring her. Her temperature was good since she woke up. It was about 100 when she went to bed last night on 24Jan2021. The achiness and soreness started when she got up around 6am yesterday and it was still there but much better. Reports she had arthritis and her joints were sore anyways but this soreness was more. She had a lot of medication that she takes but does not feel they are relevant to provide at this time. The outcome of events joint pain and pain was recovering. The outcome of event fever was recovered on 25Jan2021. The outcome of event chills was recovered in Jan2021. The outcome of rest events was unknown.
75 2021-02-10 fever, chills Patient became weak, had the chills, and spiked a fever.
75 2021-02-10 fatigue tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not i... Read more
tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not in her throat but it was on her neck behind her ear; blood pressure spiked; tired; she didn't sleep well; Chest pain; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: lot number: E19262, via an unspecified route of administration, left arm, on 26Jan2021 10:00 at a single dose to not get Covid and to protect others around her. Medical history included mini stroke at least 8-10 years ago and neuropathy in face from ministroke. Concomitant medication included gabapentin for neuropathy in face from ministroke. The patient had no prior vaccinations (within 4 weeks). The patient previously took pregabalin (LYRICA): but was changed to gabapentin. On 26Jan2021, the patient experienced tingling of lip and face, numbness on left side of face, blood pressure spiked and chest pain. On 27Jan2021, the patient experienced tired. The events were described as: After getting the vaccine, she experienced tingling of the lip and left side of her face. She had numbness on the left side of her face. The numbness was not in her throat but it was on her neck behind her ear. Her blood pressure spiked. She drover herself to the emergency room. Her blood pressure was 160 something over 101. She was unable to specify the exact number. Then her blood pressure decreased to 104 over 80 something and it increased to 202 systolic. She was unable to specify the reading. She was tired on 27Jan2021 because she didn't sleep well in the hospital. She signed out against medical advice. The patient had a full work up to include a CT scan, MRI and doppler: results were not provided (unknown results). The patient wanted to know if recommendations were made in regard to taking the second dose if they have had adverse events. The patient was hospitalized from 26Jan2021 to 27Jan2021 (1 day) for tingling of lip and face, numbness on left side of face and blood pressure spiked. Chest pain was considered medically significant by the reporter. The outcome of she didn't sleep well was unknown. The patient was recovering from tingling of lip and face and tired. The patient has not recovered from numbness on left side of face. The patient recovered from blood pressure spiked and chest pain on 27Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
75 2021-02-11 headache Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next... Read more
Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next day had class collapsed and stubbed toe, bleeding etc. ambulance came and assessed, PT felt so weak could not stand but was declared ok to drive by emt, got home and collapsed on the floor and crawled around for 6 days, lived on boiled eggs and rice cakes, doctor said call an ambulance, ambulance picked her up and took her to hospital, hospital took care of her for 16 days, got discharged yesterday (2-9-2021)
75 2021-02-11 malaise On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed ... Read more
On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed away.
75 2021-02-14 chills, fever body is very sore; severe chill rigors; couldn't get out of the bed because the rigors were so inten... Read more
body is very sore; severe chill rigors; couldn't get out of the bed because the rigors were so intense that legs would not support her; a slight fever; This is a spontaneous report from a contactable consumer reported for herself. A 75-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 30Jan2021 11:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included venlafaxine, levothyroxine, diclofenac, gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 09Jan2021 11:30 AM for covid-19 immunization. Initially the patient noticed a slight fever 11 hours after vaccine on 31Jan2021. Then about 12 hours after her vaccine on 31Jan2021, she had severe chill rigors for about 2.5 hours. She couldn't get out of the bed because the rigors were so intense that her legs would not support her. On 31Jan2021 12:00 AM, (12 hours after the rigors), her entire body was very sore, feeling as if she had been run over by a truck. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the Lot/Batch number has been requested.
75 2021-02-14 throat pain, fatigue, headache, malaise sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just k... Read more
sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just kind of foggy; This is a spontaneous report by a contactable consumer (patient). This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left upper arm on 20Jan2021 07:30 for Covid-19 immunisation. Medical history none. There were no concomitant medications. The patient experienced headache on 26Jan2021 with outcome of unknown, don't feel well in Jan2021 with outcome of unknown, weak in Jan2021 with outcome of unknown, nauseated in Jan2021 with outcome of unknown, sore throat on 28Jan2021 with outcome of not recovered, hoarse in Jan2021 with outcome of unknown, she feels tired in Jan2021 with outcome of not recovered, her mind is just kind of foggy in Jan2021 with outcome of unknown.
75 2021-02-15 chills Chills and muscle weakness that started on 2/13 PM and then mom suffered a basal ganglia stroke on 2... Read more
Chills and muscle weakness that started on 2/13 PM and then mom suffered a basal ganglia stroke on 2/14 PM.
75 2021-02-17 fatigue This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female pa... Read more
This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 29Jan2021 (at 14:30) at single dose on the left arm for COVID-19 immunisation, administered at clinic. Relevant medical history included persistent genital arousal disorder. Past drug history included allergy to codeine. The subject was receiving concomitant medications (unspecified). No other vaccine was received in four weeks. On 01Feb2021, the patient developed severe fatigue, inflammation, swelling, and soreness under tongue....5 days and counting (as reported). The events were assessed as non-serious. The patient had not recovered from the events. Information on the Batch/Lot number has been requested.
75 2021-02-17 headache Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue... Read more
Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; headache; high bp/ had a BP 173/113; short of breath; couldn't sleep; restless; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Ten minutes after she reported having a headache, which she ignored. 2 hours later, very high blood pressure (BP), short of breath (SOB) and restless occurred. All night on 25Jan2021 and the next day on 26Jan2021, the patient couldn't sleep, short of breath, restless. The patient called PCP and was told to go to the ER. She did and had a BP 173/113, SOB. She was admitted, CT scan was ok. She had very bad rash blue red swollen on thigh. Heart enzymes was normal. She was discharged two days later referral to a dermatologist. The outcome of events was unknown. Information on the batch number has been requested.
75 2021-02-21 cough, throat pain, productive cough About 11 am I was masked in church and developed a tickle in my throat. I cleared my throat to no r... Read more
About 11 am I was masked in church and developed a tickle in my throat. I cleared my throat to no relief. I took 2 cough drops. About 11:30 I got a bottle of water. No relief after drinking 8 ounces. I left the service, went outside, removed my mask and was coughing forcibly for about 15 minutes or so. Expectorated clear phlegm 6 - 8 times. Gradually I settled to normal. Just some residual soreness in throat. This was an unusual occurrence for me. I was covid positive in early Dec, but had a very mild case. Back in the 70's I would have reaction to allergy shots. I waited in the office 15 minutes, but 45 minutes later when I arrived home I had huge hives and severe itching.
75 2021-02-21 headache Severe shaking during teh night with chest congestion and headache. Resolved by teh following day at... Read more
Severe shaking during teh night with chest congestion and headache. Resolved by teh following day at 3pm
75 2021-02-21 fatigue, body temperature increased, headache Sore arm; Temp of 100 for 2 days; general aches; fatigue; zero energy; headache on day 3
75 2021-02-22 chills Face swelling, chills
75 2021-02-22 chills, headache generalize aching, chills with no fever, pain at the site of injection, headache, lasting for one d... Read more
generalize aching, chills with no fever, pain at the site of injection, headache, lasting for one day. Tylenol helps with the symptoms.
75 2021-02-23 fever 2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging... Read more
2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging, itchy, and noted right above the swollen are three red areas size of tip of my pinky. (these redish spots same on my first vaccination). A few hours after I took my temp and was 99.1. I double checked and 99.1. I took one Motrin for fever and couple hours no fever. Today 2/24= Lump swelling decreased and warm to touch. I have been applying Hydrocortisone Cream 1% for mild itching.
75 2021-02-23 fatigue Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of a... Read more
Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (lot number: EL9262), via an unspecified route of administration, at arm left, on Jan2021 at single dose for COVID-19 immunisation. Medical history included Prediabetes from 2019 (reported as diagnosed two years ago), overweight from an unknown date, ongoing arthritis from 2017 (reported as about 4 years ago), gets worse now. There were no concomitant medications. Caller states she just has a question, states she took the test about 2 weeks ago, clarifies the Pfizer vaccine and due for next one on Sunday, caller wanted to find out if what she experienced could be due to the vaccine, states she had a reaction for almost two weeks (also reported that all the events started on 05Feb2021, pending clarification), states her blood pressure went up, she had chest pain in her chest, weakness, loss of appetite, states it lasted about 24 hours, no exact dates provided. Also experienced Bell's Palsy states it comes and goes, that when she talks the saliva comes down the side of her mouth. States her Blood pressure went really high, 145/90 or so, lasted about 24 hours. Did not know if she was having a heart attack. Does see a cardiologist because of a family history of cardiac issues. The outcome of the event Bell's Palsy was not recovered, of the other events was recovered on Jan2021 (reported as lasted for 24 hours).
75 2021-02-23 headache, body temperature increased, chills, fatigue, fever Evening Feb. 15, chills, fever, muscle aches, and headache and exhaustion. Night sweats with tem... Read more
Evening Feb. 15, chills, fever, muscle aches, and headache and exhaustion. Night sweats with temp. up to 101.8. Day temps 99 to 100. Have lasted to the present time. Treatment fluids and aspirin. Chest x-ray and urinalysis clear. Covid nasal test yesterday, Feb.23. The second Pfizer vaccine scheduled for today, Feb. 24, was cancelled.
75 2021-02-23 headache Head ache, nausea
75 2021-02-23 headache, fatigue Vaccine administration error: Undiluted vaccine was given. Patient was monitored from 1/20/21 to 2/... Read more
Vaccine administration error: Undiluted vaccine was given. Patient was monitored from 1/20/21 to 2/4/21. Injection site pain, tiredness and headaches were the only symptoms reported by patient.
75 2021-02-23 influenza like illness, headache flu like symptoms; diarrhea; severe/bad headache; nausea; This is a spontaneous report from a contac... Read more
flu like symptoms; diarrhea; severe/bad headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL9261; expiry date: unknown) at the age of 75 years old, via an unspecified route of administration in the right arm, on 23Jan2021 09:00, at a single dose, for COVID -19 immunization. The patient had no relevant medical history and was not taking concomitant medications. Patient reported that she got the Pfizer Covid vaccine shot on 23Jan2021 at 9:00. On 24Jan2021, about 2:00, the next morning, she felt like she got hit by a bus further described as flu like symptoms including nausea, diarrhea, and a severe/ bad headache. The events were treated with Phenergan at home. These symptoms lasted about a day; patient completely recovered on 25Jan2021.
75 2021-02-24 influenza like illness, lethargy, headache Day 2: flu like symptoms. W/o fever. Confined to bed Day 3: same but part time in bed Day 4: redu... Read more
Day 2: flu like symptoms. W/o fever. Confined to bed Day 3: same but part time in bed Day 4: reduction in flu like symptoms but disoriented and lethargy and headache Day 5: disoriented and lethary Day 6: same Day 7: shakey and lethargic Day 8: same
75 2021-02-24 fatigue, throat pain, fever, respiratory tract congestion Mild reaction lasting 48 hours - achy arm at injection site, brain fog, congestion, slight sore thro... Read more
Mild reaction lasting 48 hours - achy arm at injection site, brain fog, congestion, slight sore throat, fever: 98.9-99.9, fatigue
75 2021-02-24 headache Pt developed chest tightness approx 10-15 minutes post vaccination. Also c/o HA and dizziness. BP 1... Read more
Pt developed chest tightness approx 10-15 minutes post vaccination. Also c/o HA and dizziness. BP 138/63 HR 66 SpO2 98% RA Pt brought to ER
75 2021-02-24 fatigue VR stated burning sensation through neck and up into head. VR noted fatigue within 5 min of vaccinat... Read more
VR stated burning sensation through neck and up into head. VR noted fatigue within 5 min of vaccination. Observed for an extra 15 min. vitals stable. symptoms subsided within 5 min of onset
75 2021-02-25 headache, fever, sweating After vaccine, the next day 3-4am woke up with horrible headache, slight fever, sweaty. injection si... Read more
After vaccine, the next day 3-4am woke up with horrible headache, slight fever, sweaty. injection site raised and red and still is, also has trouble keeping liquid or food in. Still gets fleeting headaches and sweats ever morning.
75 2021-02-25 headache Really bad headache and need to sleep for at least 36 hours. No treatment.
75 2021-02-25 malaise, sneezing, runny nose, nasal congestion Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sin... Read more
Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sinuses, red burning eyes, constant sneezing and dripping nose, weak and shaky on my feet. Lose of appetite, constipation and nausea.. It lasted for 4 days and on Wednesday I called my medical care giver and she said that I probably had an allergic reaction to the vaccine and to not take the next dose, as this had been my first. I am still, periodically week and dizzy, and still have little appetite.
75 2021-02-25 chills, fatigue, sleepiness Worst flu ever symptoms. Chills; fatigue: sleepiness,
75 2021-02-25 fatigue absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; Incre... Read more
absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; Increasing fatigue and shortness of breath; Increasing fatigue and shortness of breath; absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; This is a spontaneous report from a health care professional, the patient. A 75-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration from in the right arm on 29Jan2021 at 13:30 (at the age of 75-years-old) as a single dose, for COVID-19 vaccination. Medical history included heart valve replacement (under the care of cardiologist for heart valve leakage causing some shortness of breath & fatigue, but was manageable), thyroid cancer, breast cancer female and tricuspid valve disease. Patient did receive concomitant medications in two weeks but details were not provided. The patient previously took penicilin and experienced drug hypersensitivity.. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 01Feb2021 at 12:00, The patient experienced absolute neutropenia (medically significant) and relative lymphocytosis, normocytic anemia and a typical monocular cells, and increasing fatigue and shortness of breath (in 2 weeks since vaccine on 29Jan2021; almost debilitating). The patient underwent lab tests included Blood test 4 months earlier results were normal on an unspecified date, Blood Test during routine check-up on 02Jan2021, revealed absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells. . No treatment was given for the events. Consumer inquired if the vaccine can contribute to increase in fatigue and shortness of breath and new blood work reading. The clinical outcome of the events absolute neutropenia, lymphocytosis, normocytic anemia and a typical monocular cells, and increasing fatigue and shortness of breath was not recovered.
75 2021-02-25 sweating patient was diaphoretic x 15 secs. symptoms resolved.
75 2021-02-27 head discomfort Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feel... Read more
Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feeling pressure in the head I have observed Patient having red face itchy face foggy pressure in the head. Vital signs: 0843 BP 170/80 HR 96 RR 18 Pulse Ox 98% 0846 BP 182/80 0857 BP 168/84 HR 88 RR 16 Pulse Ox 97% 0910 BP 180/90 HR 88 RR 16 Pulse Ox 97% 0925 BP 200/90 HR 88 RR 16 Pulse Ox 97% Treatment/intervention Monitored offered water Benadryl 25 mg po @ 0850 by an RN, Benadryl 25 mg po @ 0914 by an RN 0925 patients BP continued to be out of normal range patient stated that she took her BP medications this am. Face still flushed. 0925 ambulance called to transport patient to the ED. 0925 ambulance her report given.
75 2021-02-27 chills, headache Severe headache, took tylenol, lasted approx 24 hrs. Chills, bundled up and slept eventually, lasted... Read more
Severe headache, took tylenol, lasted approx 24 hrs. Chills, bundled up and slept eventually, lasted approx. 10 hrs. 3 days later red rash started on left arm from inj. site almost to elbow and width of arm. Have taken 2 benadryl. Still have rash. It's Sunday 02/28/2021
75 2021-02-27 headache Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of ... Read more
Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of feet, muscle weakness, dry mouth, joint pain, headache,...
75 2021-02-28 chills, headache After 24 hours for about 6 hours and again 48 hours for about 6 hours: chills, body aches, headache,... Read more
After 24 hours for about 6 hours and again 48 hours for about 6 hours: chills, body aches, headache, dizzy, nausea; then after 9 days (February 25), same symptoms for about 6 hours.
75 2021-02-28 body temperature increased, headache, chills At 9:30 A.M. on 2/23, I noticed that I had a slight headache. My left arm was, as I had expected, p... Read more
At 9:30 A.M. on 2/23, I noticed that I had a slight headache. My left arm was, as I had expected, painful and red near the injection site. As the day progressed, I became aware of more reactions: chills, body aches, increasing headache, arm pain, and changes in my temperature (I usually have a temperature of 97.6, but measured 96.6 and in the evening, 100.4). I felt listless and nauseous by dinnertime. By the morning of 2/24, nothing was improved, so I took 2 Tylenol, which I repeated 7 hours later and 7 hours after that. By the morning of 2/25, I began feeling better and stopped the Tylenol. My symptoms gradually continued to improve through 2/28.
75 2021-02-28 malaise, fever Fever; feels lousy; This is a spontaneous report from a contactable consumer reporting for herself. ... Read more
Fever; feels lousy; This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 26Jan2021 at 18:10 (at the age of 75 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included 3 cardiac stents on an unknown date. Concomitant medication was not provided. On 27Jan2021 at 15:00, the patient experienced fever all day. The patient's highest body temperature was on 27Jan2021 at 101.9 F and on 28Jan2021, the temperature was 101.4 F. On 27Jan2021 (time unspecified), the patient stated that she feels lousy. The outcome of the events fever and feels lousy was not recovered.
75 2021-02-28 fatigue, malaise, body temperature increased, chills, headache Injection site pain, Chills, 102 fever 24 hours for 3 days, headache, tiredness, muscle pain, joint ... Read more
Injection site pain, Chills, 102 fever 24 hours for 3 days, headache, tiredness, muscle pain, joint pain, feeling unwell
75 2021-02-28 fever, sleepiness, headache On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a ... Read more
On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a fever; slept for 15 hours; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 17:00 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse and COVID-19. Concomitant medication included bimatoprost (LUMIGAN), colecalciferol (D3), zinc (ZINC), and ubidecarenone (COQ10). The patient experienced severe muscle ache, severe headache, nauseous, so cold (could not get warm), had a fever and slept for 15 hours on 26Jan2021 21:00. The patient received no treatment. The outcome of the events was recovered with sequelae on an unspecified date.
75 2021-02-28 chills, fever, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA 2" diameter red and itchy area around injection site and 3" lon... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 2" diameter red and itchy area around injection site and 3" long by 1/4" wide red line from injection site to arm pit, that lasted 1 week. Also, 101 temp, some chills, light headache, upper teeth hurt (like in sinus infection) and tired that lasted 1 day.
75 2021-02-28 fatigue, fever, malaise Pt was brought to ED due to altered mental state, apparently after pt received first Covid vaccine, ... Read more
Pt was brought to ED due to altered mental state, apparently after pt received first Covid vaccine, she didn't feel quite well, fatigued; after recent 2nd Covid vaccine, pt had been noted to be confused with poor appetite. Pt also with recent dx hypopituitarism - has been on desmopressin/ prednisone - per report from family members, pt had been drinking a lot of water. In ED, Pt was noted with hyponatremia - NA 124, Lactic acidosis 2.1, low grade temp - PCT wnl.
75 2021-02-28 productive cough Spiting up white flem ,when getting up in the morning and during the day !pain left side !Lung?
75 2021-02-28 fatigue, chills hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling ki... Read more
hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling kind of weird, off balance; Upset stomach; Chills; She cannot function very good, She is feeling so bad and cannot do nothing; At night time it is hard to try to do something and she cannot do it because she is tired; can hardly breathe at night; it kind of feels like she has an ear ache but she does not have an earache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via intramuscular route of administration on 14Jan2021 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) from an unknown date (per patient diagnosed quite a while ago and she goes to a pulmonary doctor). Concomitant medications included unspecified inhaler at two puffs per day if needed and unspecified recue inhaler one puff a day as needed, both ongoing for one year for COPD. The patient did not receive any other vaccines within four weeks prior to the vaccination or any other prior vaccinations or any vaccinations on the same date of the vaccination. The patient experienced chest pain, feeling abnormal, feeling off balance, upset stomach, chills, cannot function very good, tired, can hardly breathe at night and ear discomfort, all in Jan2021. The patient reported she received the vaccination on 14Jan2021 by her primary doctor. She is feeling kind of weird and has an upset stomach. She is asking how long this will last. She is worried about taking the second dose. She is supposed to have the second dose on 04Feb2021. She cannot function very good, states it kind of feels like she has an ear ache but she does not have an earache. Her balance is off and she can hardly breathe at night. All her symptoms started on the third day after getting the shot (Jan2021). She reports the feeling weird and off balance feeling feel like you are drunk. It aggravates her because she cannot function right. She also experienced chills started the third day after the shot and the chills have recovered completely. The patient reported that she was alright the first day. She has hurting in her chest, like she has to keep breathing which also started the third day after getting the shot and has been going on all this time. At night time it is hard to try to do something and she cannot do it because she is tired, states it is the worst part, She is feeling so bad and cannot do nothing. She has a hard time breathing. The events did not require a visit to emergency room or physician office. The patient did not have any relevant tests. The clinical outcomes of the events chest pain, feeling abnormal, feeling off balance, upset stomach were not recovered. The patient recovered from the chills in Jan2021. The outcome of the cannot function very good, she is feeling so bad and cannot do nothing, tired, can hardly breathe at night and ear discomfort was unknown.
75 2021-03-01 fever I didn't feel good the nite I had the shot, next day I stayed in bed with 101 fever. The 6th of Feb... Read more
I didn't feel good the nite I had the shot, next day I stayed in bed with 101 fever. The 6th of Feb, fever gone, but large lymph gland under the shot arm was obvious. I have done lymphatic massage everyday since, and finally on Feb 26, it finally dissipated and will have a Mammo in May.
75 2021-03-01 influenza like illness, lethargy Lethargic; Flu like symptoms; Lower part of my leg, I have little bit rash, a redness; Lower part of... Read more
Lethargic; Flu like symptoms; Lower part of my leg, I have little bit rash, a redness; Lower part of my leg, I have little bit rash, a redness; I have few spots on my right forearm; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 75 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing and anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medication included dronedarone hydrochloride (MULTAQ) at 400mg, twice daily and apixaban (ELIQUIS) at 5mg, two times daily. The patient stated, "Both my husband and I took the Covid the first shot on 22Jan2021 which was week ago today. I noticed about 4 days later (Jan2021) like I started feeling you know flu like symptoms but they were mild, if I took two an Extra strength Tylenol it went away. You know what I mean. So that one for about may be one, two may three days and that was it. I was very lethargic. The only thing I did notice that on both my legs from the ankles of about midways I have you know my leg, the lower part of my leg, I have little bit rash, a redness. It does not itch, it was not hard to the touch. My body temperature was normal. It was little red or pinkish to a little bit of red. Now, I noticed tonight that I have few spots on my right forearm. Like I said we have shot on 22nd, everything was fine, no immediate reaction or anything else and everything is okay. I just you know I feel fine but is this normal?" The patient stated, "No, they are healthy and safe about 20-25 minutes. Everything was fine and then let us go and I said couple of days later it hasn't progressed, it is very, it is on both of my lower legs from ankles midway up my legs and I noticed couple of spots on my left forearm but it hasn't gotten any worst and it hasn't gotten spread on any place other than right forearm." The patient also stated, "You mean the rash or any other the symptoms. We have the shot Friday, Saturday, Sunday, Monday. I was say this past Tuesday, around 26th (further not clarified)." The patient stated, "It was there on my legs. It hasn't moved. It hasn't gotten any worse and it is only on front it is not back on my legs. The only thing I noticed tonight that it is couple of spots on my right forearm." The consumer stated, "No, I went to see my doctor the other day for her to take look at it. I went to see PA at my doctor's office, I saw her and she said if it doesn't get worse it would probably go away." The patient also stated, "The only thing that I had done right before the Covid Vaccine. I had injection in my knee of amniotic fluid for a torn meniscus but that should not affect it." The patient underwent lab tests and procedures which included body temperature: normal on an unspecified date. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.
75 2021-03-01 fatigue thought it was my tooth bleeding because that's what it looked like if you cut yourself; the phlegm... Read more
thought it was my tooth bleeding because that's what it looked like if you cut yourself; the phlegm she spitted up this morning had blood in it; she started to bleed/nose bleed coming out of my mouth; achy; tired; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 28Jan2021 08:05 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included an unspecified sinus disorder, unspecified allergies and reflux usually after eating, all from unknown dates and unknown if ongoing. The patient's historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on 06Jan2021 with no specified side effects. The patient's concomitant medications were reported as unspecified medications for sinus problems and allergies. The patient stated that she got the second dose on "Thursday." She experienced side effects "that everybody has like achy and tired for two days." She continued to say that she normally spits up phlegm in the morning from sleeping overnight because she has sinus issues and she snores. This morning ("Saturday") it was pinched with blood and she was bleeding, just bleeding. She's not bleeding anymore because she has a mouthwash medication to make gargles and also with salty water. She thought it was her tooth bleeding because that's what it looked like if you cut yourself. It has stopped. She also noted that it was more like a nose bleed coming out of her mouth. She gargled with warm salted water. Treatment of the events blood in sputum, nose bleed and tooth disorder included using a mouthwash medication to make gargles and also warm salt water. The clinical outcomes of achey and tired for two days were reported as unknown. The clinical outcomes of blood in sputum, nose bleed and tooth disorder were reported as recovered on an unspecified date in Jan2021.
75 2021-03-02 throat pain, headache AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarifie... Read more
AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.
75 2021-03-02 chills, headache, fatigue Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This ... Read more
Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received first dose BNT162B2 (Solution for injection, Lot number: EL9264) via an unspecified route of administration on 31Jan2021 16:00 at single dose in right arm for covid-19 immunisation. Medical history included breast cancer and hodgkin Lymphoma. Concomitant medication included simvastatin, vitamin d nos. The patient had extreme tiredness, nausea, feeling like I was run over by a truck, chills, headache, weakness on 01Feb2021 at 13:00 pm. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. The outcome of the events was recovering.
75 2021-03-02 fever, cough Fell feverish on and off; a lot of coughing; a lot of wheezing; This is a spontaneous report from a ... Read more
Fell feverish on and off; a lot of coughing; a lot of wheezing; This is a spontaneous report from a contactable consumer (patient) for herself. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: pfizerbiontech) via an unspecified route of administration at left arm on 06Feb2021 at 04:00 AM at a single dose for COVID-19 immunisation. Age at vaccination was reported as 75-year-old. Medical history included fibromyalgia and arthritis. Allergies to medications, food, or other products reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included lisinopril, omeprazole and pregabalin. Facility where the most recent COVID-19 vaccine was administered at a drug store. The patient experienced adverse events included fell feverish on and off, a lot of coughing, a lot of wheezing; with adverse event start date on 11Feb2021 at 09:00 AM. The events were reported as non-serious. The outcome of events was unknown. Treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Information on the lot/batch number has been requested.
75 2021-03-02 chills Patient experienced chills and flushing minutes after vaccine administration. Vital Signs stable. Sp... Read more
Patient experienced chills and flushing minutes after vaccine administration. Vital Signs stable. Spontaneous improvement. No medications offered.
75 2021-03-02 runny nose Runny nose; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female... Read more
Runny nose; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included citalopram hydrobromide (CELEXA). The patient experienced runny nose on 29Jan2021 08:00. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovering. Information on the lot/batch number has been requested.
75 2021-03-02 fever has lupus and a couple days ago, she started having inflammation pain; has lupus and a couple days a... Read more
has lupus and a couple days ago, she started having inflammation pain; has lupus and a couple days ago, she started having inflammation pain; Fever; Achy; Pleuritic pain; Shortness of breath; O2 level was a little lower it was in the low 90's and she usually runs 96 to 97; This is a spontaneous report from a contactable consumer reporting for herself. A 75-years-old female patient received the second dose of bnt162b2 (BNT162B2)vaccine , intramuscular in the right arm on 08Feb2021 15:30 at single dose for covid-19 immunisation . Medical history included systemic lupus erythematosus , asthma, thyroidectomy . The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on 18Jan2021. The patient has lupus and a couple days ago, she started having inflammation pain on 14Feb2021 with outcome of unknown, O2 level was a little lower it was in the low 90's and she usually runs 96 to 97 on Feb2021 with outcome of unknown , fever on 09Feb2021 with outcome of unknown , achy on 09Feb2021 with outcome of unknown , pleuritic pain on Feb2021 with outcome of recovering , shortness of breath on Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included oxygen saturation: low 90's. The second day, she had a little bit of a fever and was achy. She has lupus and a couple days ago, she started having inflammation pain. It has progressed and went to pleurisy pain. She has really been down for the count. She has had problems breathing with the pleurisy pain, but she has had no fever. She has had a little shortness of breath. She has a pusle oximetry and her O2 level was a little lower, it was in the low 90's and she usually runs 96 to 97.The patient has taken Tylenol and the pleurisy pain is better. She can breathe without pain. The patient is wondering if the vaccine causes problems or after affects for more than a week sometimes or if this is just plain lupus causing issues. Information on the lot/batch number has been requested.
75 2021-03-02 fever it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appeti... Read more
it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appetite; Nausea; breathing problems; mild fever; Muscle ache; Joint ache; Rapid heart rate up to 130; Itchy skin; roof of mouth itching; eyes were also really sore; This is a spontaneous report from a contactable Other HCP (patient). A 75-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing asthma initially diagnosed at 21 years old, ongoing arthritis diagnosed 10-15 years before but she thinks she had it since she was 35, multiple joint replacements, past pneumonia. The patient's concomitant medications were not reported. The patient previously received methotrexate 25mg a week orally for arthritis but she quit taking it about 3 months before in preparation of getting the vaccine. The patient previously received the first dose of bnt162b2 on unspecified date (lot EL8982) at single dose for COVID-19 immunisation in the right arm. The patient experienced mild fever on 12Feb2021 with outcome of recovered on 14Feb2021, roof of mouth itching on 11Feb2021 with outcome of recovered on 11Feb2021, muscle ache on 12Feb2021 with outcome of recovered on 12Feb2021, joint ache on 12Feb2021 with outcome of recovering, breathing problems on 12Feb2021 with outcome of recovering, rapid heart rate up to 130 on 12Feb2021 with outcome of recovering, itchy skin on 11Feb2021 with outcome of recovered on 11Feb2021, it showed a "crp value" of 11.5 which is usually below 0.29 on 15Feb2021 with outcome of unknown, nausea on 12Feb2021 with outcome of recovered on 13Feb2021, loss of appetite on 13Feb2021 with outcome of recovered on 13Feb2021, eyes were also really sore on 11Feb2021 with outcome of recovered on 15Feb2021. An EKG performed on 15Feb2021 as pending results. The event of breathing problems was serious due to disability. The events mild fever, roof of mouth itching, muscle ache, joint ache, rapid heart rate up to 130 and itchy skin were medically significant. The patient reported that initially, the roof of her mouth started itching. It literally happened as soon as she had the vaccine. She took a Benadryl. She didn't have a skin irruption, but did have itchy skin. The next day, she had a low grade fever. She had muscle and joint aches. She had no rash, but a little nausea. She had breathing problems. She had asthma issues and wheezing after the vaccine. That is how she described her breathing issues. She had a rapid heart rate. It went up to 130. It could of been because of fever, her breathing, or pain. There was a period of days then it resolved. On 15Feb2021, she feels almost human. She had routine arthritis lab drawn on 15Feb2021. They showed a CRP level of 11.5 which shows inflammation. She normally was below 0.29 which was within normal limits. That was an extreme difference. That was a lot of inflammation. The patient had to get her nebulizer out to breathe. She has taken Tylenol a couple of times. Her lab work was essentially normal. The CBC and chemical panel was okay. The patient thoughts the fever was important because she has been immunocompromised for years by Methotrexate. She has had pneumonia before with no fevers. Her eyes were also really sore. They bothered her. She already had to use eye drops. That was 11Feb2021 it was gone on 15Feb2021 but it kind of lasted a few days. Her muscles were better, but her joints still hurt some. But her joints always hurt some. She has had multiple joint replacements. The muscles in her legs were severe Friday and Saturday. Her muscles aren't hurting now, but her joints were but that was kind of normal. Her peak flow was way down on 14Feb2021. It was at 250. She did finally get it up to 350 by using her nebulizer. Her best effort normally is 450. Her peak flow was down quite a bit. She has been having breathing changes for a year. They were not sure what it was about. It could be an acute episode of something. On unknown date (next morning as reported), her pulse was 90-100. Now her heart rate was only elevated with activity. Her heart rate was down in the 70s, but when moving it was in the low 100s. With activity it was still up. It was hanging out in the 70s except exercising. She considers walking across the room exercising. All her other labs were in within normal limits. The patient wanted to know if the inflammatory response was secondary to the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
75 2021-03-02 pneumonia pneumonia; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers repor... Read more
pneumonia; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL1284, via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included cholesterol (abnormal) and asthma. Concomitant medication included budesonide, simvastatin for cholesterol and benralizumab (FASENRA) for asthma. She has got a lot of other medications (at least 15 medications). The patient was hospitalized this week due to a pneumonia on 13Feb2021 (in between 1st dose and 2nd dose). The patient was in a hospital for 7 hours in and out. She was hospitalized in 13Feb2021. She missed the 2nd appointment today (16Feb2021) 11:30AM and they were informed that they need to call. The healthcare professional advised not to as she was on antibiotics (levofloxacin 750 mg) for pneumonia which was contracted after the first dose. She then wanted to reschedule her second dose. The patient underwent lab tests and procedures which included blood, x-rays, CAT scan and tested for virus, influenza. The tests were done in the hospital and she way okay.
75 2021-03-03 headache, fever, chills Fever, chills, really bad headache. Took 200 mg of Acetaminophen at 9:AM (after 8 hours), and slep... Read more
Fever, chills, really bad headache. Took 200 mg of Acetaminophen at 9:AM (after 8 hours), and slept all day. Felt fine when I woke up. around dinner time.
75 2021-03-03 headache HEADACHE, PRESENTS WITH FACIAL BUTTERFLY RASH AFTER COVID VACCINE. NO REDNESS AT INJECTION SITE. MED... Read more
HEADACHE, PRESENTS WITH FACIAL BUTTERFLY RASH AFTER COVID VACCINE. NO REDNESS AT INJECTION SITE. MEDICAL HISTORY SHOWS REACTIONS TO VACCINATIONS. AT 1305 BP 134/86 HR 78 O2SAT 95 SKIN WARM AND DRY DIAPHORETIC, AND BILATERAL FACIAL RASH. BREATH SOUNDS CLEAR BILATERALLY. PT ESCORTED TO TRIAGE AREA, VITALS TAKEN AND CONTINUE TO MONITOR. PT STATES FEELING LIGHT HEADED, PROVIDED PT JUICE TO DRINK. REASSES AT 1320 BP 140/82 HR 83 RESP 20 O2SAT 94 SKIN WARM AND DRY BILATERAL BREATH SOUNDS CLEAR. PT ESCORTED TO OBSERVATION AREA FOR 15 MINUTES AFTERWARDS PT CLEARED TO LEAVE.
75 2021-03-03 chills, fatigue dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd fe... Read more
dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd feeling all over, fatigue
75 2021-03-03 headache, fatigue severe reaction the day after 2nd shot. I have had 5 separate joint replacements d/t severe arthrit... Read more
severe reaction the day after 2nd shot. I have had 5 separate joint replacements d/t severe arthritis. I had severe pain in all of the replacements especially the 2 most recent. Even the 3 dental implants hurt. No Temp but severe fatigue, headache. Unable to get out of bed. It took 4 days to begin to start getting back to normal for me.
75 2021-03-03 headache sore muscle around my neck; when in bed last night, she could not turn her head without it been so p... Read more
sore muscle around my neck; when in bed last night, she could not turn her head without it been so painful; had discomfort in her shoulder and stiffness; had discomfort in her shoulder and stiffness/neck was so stiff that it hurt to turn her/can hardly turn her neck; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration on 30Jan2021 at 16:10 (4:10 pm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the same night of vaccination, the patient had discomfort in her shoulder and stiffness. On Monday, 01Feb2021, patient reported that her "neck was so stiff that it hurt to turn her head". She can hardly turn her neck. She added when in an "upright" position "it is ok" but "when in bed last night, she could not turn her head without it been so painful" to the point where she felt like she "would cry out". On an unspecified date it was reported that patient had sore muscle around my neck. The patient mentioned she alleviates her pain with "Tylenol, hot compresses, took a towel and put hot water on it and then put it around my neck, and a cream for soreness". The patient took a Tylenol last night and put hot compress on it. And rubbed it with a muscle something for a sore muscle. But it still very painful. The patient doesn't know whether it's related to the vaccine or not. The outcome of the event sore muscle was not recovered while for the rest of the events was unknown.
75 2021-03-04 headache Client verbalized feeling sudden headache after receiving the vaccine. Client was evaluated. Mrs.... Read more
Client verbalized feeling sudden headache after receiving the vaccine. Client was evaluated. Mrs./Ms. was released to go home at 10:51 am after symptoms subsided accompanied by niece.
75 2021-03-04 chills, fever, headache, fatigue My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe head... Read more
My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe headache. As the night continued on she had fever chills that would come and go all night causing her not to get much sleep. Day two the chills were gone but still very achey, weak, tired and headache. Day three she is still tired and weak with headache.
75 2021-03-04 fatigue Patient reports a burning sensation in her chest, weakness, and fatigue. States this started Wednes... Read more
Patient reports a burning sensation in her chest, weakness, and fatigue. States this started Wednesday following the vaccine.
75 2021-03-04 fatigue, chills, malaise, headache chills to where body was shaking, headache, tiredness, hard to get out of bed, just not feeling well... Read more
chills to where body was shaking, headache, tiredness, hard to get out of bed, just not feeling well . This lasted a day, feel better today
75 2021-03-07 headache, chills Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms;... Read more
Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.
75 2021-03-08 headache, fever, fatigue Fever, intractable nausea and vomiting, fatigue, headache, body aches and diarrhea
75 2021-03-08 headache arthritis; fingers on right were all swollen; she could barely move her arm; right hand and wrist wa... Read more
arthritis; fingers on right were all swollen; she could barely move her arm; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; light headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unspecified route of administration on 26Jan2021 at 10:40 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included arthritis from an unknown date, renal cancer since 07Dec2020 and ongoing, atrial fibrillation since 2006 and ongoing, partial nephrectomy on 06 Jan2021. She specified that she has an arthritis flare up about once a year and normally takes a Medrol dose pack. The patient's historical vaccines included an unspecified flu vaccine (MANUFACTURER UNKNOWN) on an unspecified date about ten years ago after which she had to go to the Emergency Room for right arm redness, swelling at the injection site and face swelling on right side. She did not get another flu shot for 10 years but did get one this year in Nov2020. Concomitant medication included metoprolol (MANUFACTURER UNKNOWN), flecainide acetate (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN, MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports that she experienced a light headache. She clarified that she is in an unspecified program which includes an e-diary. As part of that program (app) she was sent a text every day for a week asking if she had any side effects; a couple times she had a headache. On the eighth day (03Feb2021) she had a reaction where her right hand and wrist was painful and swollen. Caller states she couldn't move her hand without pain. Caller states she put ice on her hand Wednesday evening and this helped a little. When ice was on her hand it helped with the pain but when it was removed it came back. She also reported fingers on right were all swollen and that she does have arthritis. She further described the events as on Wednesday she started getting a little pain in her right wrist joint. She does have arthritis, but this pain was stronger, and her hand and fingers on right were all swollen in comparison to her other hand, and her knuckles seemed bigger. States that the pain got very strong and by the next morning she could barely move her arm; even though it was only her wrist that hurt, moving any part of her arm made her wrist her more, so she started icing it and took Tylenol for Arthritis 650mg Extended Release; she took it twice, one each time and reported that it probably didn't work. Caller clarifies statement about it probably not working; stating that she didn't notice a difference after taking the Tylenol. She asked if these events, occurring eight days after the vaccine could be vaccine side effects or is this just a flare up on her arthritis that is unrelated to the vaccine. She added that she had been doing a lot of "chopping" while cooking on the night that this happened so that may have caused the flare up. She has a Medrol pack on hand for things like this (4mg tablets). She started it today and took two tablets before breakfast and one tablet at lunch. She states that it has already made a difference in her pain. She stated her concern, however, which is that she found that taking a steroid could affect the vaccine if taken before getting the vaccine, and right now she is in-between the two doses. Her second dose is scheduled for 16Feb2021. She inquired as to if she can finish this dose pack without messing up the vaccine. The clinical outcome of headache was reported as recovered. The clinical outcomes of hand swelling, wrist pain, hand pain and swelling of wrists were reported as not recovered. The clinical outcomes of arthritis flare up, swelling of fingers and could not move her arm were unknown.
75 2021-03-11 pneumonia Chest pain DOE (dyspnea on exertion) Pneumonia of both lungs due to infectious organism, unspecified... Read more
Chest pain DOE (dyspnea on exertion) Pneumonia of both lungs due to infectious organism, unspecified part of lung Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present Death
75 2021-03-11 dehydration, fever Nausea, vomiting, fever, generalize weakness, dehydration
75 2021-03-14 chills Chills; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A ... Read more
Chills; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 12:00 at single dose at left arm for covid-19 immunization. Medical history included TAVR, blood pressure, acid reflux from an unknown date and unknown if ongoing. Concomitant medications included lisinopril for blood pressure, atorvastatin, omeprazole for acid reflux, hydrochlorothiazide for water pill, spironolactone; all ongoing. The patient experienced chills, nausea, diarrhea all on 09Feb2021 with outcome of recovering. These symptoms were still there, but they're almost gone. Stated it seemed like they all came on together. No additional vaccines administered on the same date of the Pfizer vaccine considered as suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Stated she had never had a reaction after previous vaccinations. No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
75 2021-03-17 cough Rash on my chest; I guess the rash joined one another on my chest, inside my legs and both my upper ... Read more
Rash on my chest; I guess the rash joined one another on my chest, inside my legs and both my upper arms; Cough; My left arm where I got the shot that arm, it was feverish, it was very hot; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2, lot no. EL9262, via an unspecified route of administration (left arm) on 24Jan2021 at a single dose for COVID-19 immunization at a hospital facility. They gave her a dose that was recommended. Medical history and concomitant medications were not reported. The patient reported a reaction that she had to her first vaccine. It was Pfizer BioNTech COVID-19 Vaccine EUA and she had that on 24Jan2021 and she had a little cough the following day (25Jan2021) which she did not have before and then she didn't recover from the cough but she woke up on the 27th with a little bit of rash on her chest and she just kind of ignored it but within four hours she had not just a rash, she had she guessed the rash joined one another on her chest, inside her legs and both her upper arms. She started taking Benadryl and it took about 125 mg of the Benadryl over 30 hours before she was able to get rid of the rash. It happened three days later at her house. She treated herself with Benadryl. She was not experiencing any kind of breathing problems or anything that she was alarmed about. She only took Benadryl 25 mg when she first saw it because the rash was not severe but within four hours even after she took the 25 mg, the rash became very severe and her left arm where she got the shot that arm, it was feverish, it was very hot on Jan2021. She didn't know next step with her second dose. She felt like rash was severe. Her rash took over 30 hours and taking 125mg Benadryl to get rid of it. So, she didn't know how to prepare or what to expect. She was due to get it on 14Feb. The patient recovered from rash generalized on Jan2021, not recovered from cough, while outcome of other event was unknown.
75 2021-03-18 headache severe headache; complete loss of taste and smell; complete loss of taste and smell; This is a spont... Read more
severe headache; complete loss of taste and smell; complete loss of taste and smell; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9581), via an unspecified route of administration, in the left arm on 10Feb2021 at 4:15 PM (at the age of 75-years) as a single dose for COVID-19 immunization. Medical history included asthma, mite allergy, allergy to animal (cats, guinea pigs), Vasovagal Syncope. The patient had known allergies to sulfa and Iodopropynyl Butylcarbamate. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included pravastatin, ciclosporin (RESTASIS), calcium, and senior multivitamin. On 11Feb2021 about 9 hours after vaccine, at 01:00, the patient experienced severe headache and complete loss of taste and smell. No treatment was given for the events. The clinical outcome of severe headache, complete loss of taste and smell was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
75 2021-03-20 chills, runny nose, sleepiness, fatigue, nasopharyngitis, throat pain Cold like symptoms; chills; tiredness; sleepiness; runny nose; sore/red throat; sore/red throat; com... Read more
Cold like symptoms; chills; tiredness; sleepiness; runny nose; sore/red throat; sore/red throat; complete body ache and pain during night but was gone the next morning; This is a spontaneous report from a contactable Other HCP (patient). A 75-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249) via unspecified route of administration in left arm on 19Jan2021, at 15:00 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. The patient medical history included vertigo, mild heart attack and glaucoma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included glaucoma eye drops, dorzolamide and latanoprost. The patient didn't receive any vaccine within four weeks prior to vaccination. The patient previously took Fosamax and experienced light headedness (after 2 years). On an unknown date in Jan2021, the patient experienced (Night after vaccination), complete body ache and pain during night but was gone the next morning. On 01Feb2021, at 13:15 the patient had cold like symptoms starting 12 days after vaccination, chills, tiredness/sleepiness, runny nose, sore/red throat. The patient didn't receive treatment for the events. The outcome of the events complete body ache and pain during night but was gone the next morning was recovered on Jan2021 while for other events was recovering.
75 2021-03-20 malaise, chills Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen ... Read more
Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen lymph nodes that hurts like crazy; Swollen lymph nodes that hurts like crazy; arm got sore; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31May2021), via an unspecified route of administration on 03Feb2021 (at the age of 75 years) as single dose for covid-19 immunisation; potassium chloride (KLOR-CON M10), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included ongoing type 2 diabetes and ongoing high blood pressure. Concomitant medications included metformin; atorvastatin; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Consumer stated she got her Covid inoculation last Wednesday and in Feb2021, she was experiencing symptoms, adverse reactions. She had injection site pain still, muscle pain, her lungs are fine but when she breathe her front and back of her chest hurts. She had chills. She did not think she had a fever but she was definitely feeling unwell and the most difficult thing was swollen lymph nodes that hurts like crazy. She cannot read this too well. Lot was 2CI or EI EL3302 expires 31May2021. Her arm got sore but today she really started may be yesterday experiencing this muscle pain and the lymph stuff going on. Consumer stated she had no treatment. The last time her doctor gave her this new medication because she had run out of her potassium. It was called Klor-con M10 tablet. For lab work, consumer stated she did not know but right before she went there they took some blood and when the doctor gave her the Klor thing, she had a violent reaction to it. she threw up and had a lot of diarrhea and she have not taken it since. Results of lab work was unknown. The action taken in response to the events for potassium chloride was unknown. Outcome of events was unknown. Information about lot/batch number has been requested.
75 2021-03-21 chills, fever Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chil... Read more
Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chills, weakness and acute confusion ~ 3 days prior to admission. Placed on NIPPV, steroids, convalescent plasma and antibiotics. Patient died 2/24/2021
75 2021-03-24 fatigue, headache She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, an... Read more
She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better. About 12 hours later she had a headache and took some Aleve. She woke up the next morning with a severe headache and chest pain that was excruciating. Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis. They sent her home with steroids and Colchicine. They did not want to put her on NSAIDS due to possible ulcers. She all the COVID symptoms, and had severe pain still. Her daughter 3 weeks later took her to the cardiologist. She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine. She was then sent to the ER again, and went there twice. He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues. They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter. She is now back in sinus rhythm. She was advised not to get the 2nd vaccine due to the reactions from the first one. She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.
75 2021-03-24 headache all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, d... Read more
all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, dry, itchy; injection site pain and was swollen a lot; little dizziness; nausea; Muscle pain more on back side of shoulder towards neck-unbearable pain; headache; neck disfigured; rash; injection site pain; brain fog big time - disorientated, felt like brain getting damage; I'm desperate; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: solution for injection, Lot no: EN5318) via intramuscular at left arm on 19Feb2021 at 03:10 (at the age of 75-years-old) at single dose for covid-19 immunisation (at hospital). Patient medical history not reported. Concomitant medications included levothyroxine; 0.075 mg once daily for hypothyroid since 20 years; ongoing and trazodone 100 mg 1 tab daily since 20 years; ongoing. On 19Feb2021 the patient experienced injection site pain and was swollen a lot, little dizziness, nausea, muscle pain more on back side of shoulder towards neck-unbearable pain, headache, all face including eyes swollen and red, all face including eyes swollen and red, skin got creepy, dry, itchy, brain fog big time - disorientated, felt like brain getting damage, she was desperate, skin got creepy, dry and itchy. my face and neck was disfigured that don't want my children and grant children see my face. Rash-swelling, itchy and flaky skin, got a little better on 01Mar, but I still have creepy skin, flackey, itchy around eye and eyelids were swollen and dry and felt like have stones rolling in my eyes and my brain fog was very bad. I want to know if my skin will ever get better. Patent took vit-d and all the vit. Covid. Patient received treatment as OTC, Tylenol, ibuprofen, aleve. No covid prior vaccination. The reporter reported seriousness criteria as non-serious. The outcome of the events was recovering. Information on the lot/batch number has been requested.
75 2021-03-30 pneumonia, malaise The first shot made me really sick like had the flu or pneumonia or something; The first shot made m... Read more
The first shot made me really sick like had the flu or pneumonia or something; The first shot made me really sick like had the flu or pneumonia or something; The first shot made me really sick like had the flu or pneumonia or something; Body was aching and hurting so bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and asthma from an unknown date. Concomitant medications included amlodipine taken for high blood pressure; hydrochlorothiazide taken for high blood pressure; and salbutamol sulfate (VENTOLIN) taken for asthma. It was reported that the first shot made the patient really sick like she had the flu or pneumonia or something. She also took some over the counter extra strength Tylenol as her body was aching and hurting so bad. The patient had lab test in the past 2 weeks in 2021, she had her blood drawn. The outcome of the events was unknown. Information on the lot/batch number has been requested.
75 2021-03-31 chills 03/17/21: patient [resented and was admitted through the ED for chills and shortness of breath for ... Read more
03/17/21: patient [resented and was admitted through the ED for chills and shortness of breath for the last few days. 2 x rapid antigen test and tested COVID PCR positive. Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.
75 2021-03-31 fatigue Angioedema (Face); Hives (between the eyes & forehead); Extreme Fatigue; This is a spontaneous repor... Read more
Angioedema (Face); Hives (between the eyes & forehead); Extreme Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 at 15:30 at single dose in left arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EM9810. Medical history included possible atrial fibrillation, allergy to sulfa. Past drug history included allergy to antibiotic drugs, Betoptic, Motrin, Iodine, Nickel, Latex, Ragweed, Mold, Grass, Cat, Bee. The patient was not pregnant. On 03Mar2021 at 18:00 approximately, the patient experienced angioedema (Face), Hives (between the eyes and forehead), Extreme Fatigue. The patient was not treated for the events. The patient was recovering from the events. In 2017, IgG Anti-IgE resulted elevated. It was unknown if the patient had Covid before vaccination. The patient was not tested for Covid after vaccination. No follow-up attempts are possible. No further information is expected.
75 2021-04-03 headache, sleepiness, fever All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19... Read more
All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; her temperature went up to 102 degrees; terrible joint pains; she could not stay awake at all; diarrhea; nauseousness; headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration, administered in the left arm on 12Feb2021 08:30 as a single dose for COVID-19 immunisation. Medical history included dental care from an unknown date and unknown if ongoing. No concomitant drugs were reported. The patient previously received penicillin as prophylaxis prior to dental care. The patient previously received the first dose of BNT162b2 in Jan2021 (about 3 weeks prior to second dose) (Lot Number: unknown) via an unspecified route of administration in the upper left arm for COVID-19 immunisation. The patient was administered her second dose of BNT162b2 on 12Feb2021. She initially had no reaction. Then on 12Mar2021, (about 3 weeks after second dose of BNT162b2), the patient experienced all symptoms of COVID minus chest congestion, described as temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache. Patient called her doctor and thought she could get COVID test, but the doctor said she does not need it and told her not to worry. They automatically diagnosed the patient with late side effects. Doctor thinks it is late side effects of BNT162b2 because there are cases where the doctor has seen 3 weeks to a month out of people having side effects. She has had no known exposure to any infected persons; She has been isolating 99 percent of the time since this started. She went out a couple of times to the store but she was masked and did not get near anyone; The patient does not know if she might have caught COVID-19 infection and wonders if with these event symptoms, she might have caught a milder case of COVID. The patient reported that right now her temperature was 99.5 degrees. She did not use any antipyretic. The patient was recovering from the event, temperature went up to 102 degrees. Outcome of the events, all symptoms of COVID minus chest congestion/does not know if she might have caught COVID-19, temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache was unknown. Information about lot/batch number has been requested.
75 2021-04-04 pneumonia Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised ... Read more
Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised to hold blood pressure medication. On 3/8, was feeling much worse and called 911. Upon arrival (8:55), patient A&O x 4 with poor oxygen saturation (O2: 88%). Given nebulized albuterol/ipratropium. BG: 247mg/dl. Patient has episode of dry heaving after which she vagaled down with HR in the 40s. Recovered on her own. Once the nebulizer treatment ended, she was place on nasal O2 at 3 liters/minutes. Given 4mg ondansetron. Lost consciousness and respirations became agonal. Pt was bagged via BVM and noted to be in PEA. CPR initiated, including intubation. Given 1mg epinephrine. NSR obtained after two rounds of CPR. Pt arrested again shortly after arrival to ED. ACLS initiated once more. Patient expired at 10:40 am.
75 2021-04-05 pneumonia Developed COVID 2.5 weeks after first vaccination. Presented to ED due to SOB; imagine test showed... Read more
Developed COVID 2.5 weeks after first vaccination. Presented to ED due to SOB; imagine test showed pneumonia, tested covid 19 +, treated with remdesivir, dexamethasone, and O2 resulting in improvement over 5 days. Upon discharged home with home oxygen and follow-up with PCP.
75 2021-04-17 fatigue Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't mo... Read more
Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't move/tiredness; weakness; bleeding; Test: Iron; Result: Critically low; red blood cell was below 5; administered at the left upper forearm; This is a spontaneous report from a contactable nurse (patient) via Pfizer. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left upper forearm on 01Mar2021 at the age of 75-years-old as single dose for COVID-19 immunization. The vaccine was administered to the patient at a pharmacy (in a grocery store). The patient had no prior vaccinations (within 4 weeks). The patient's medical history included retired (retired registered nurse), ongoing depression (has had this condition for probably 20 years), ongoing lung cancer (has had this condition for probably 3 years), ongoing bipolar (has had this condition for about 4 years), ongoing emphysema (has been severe for about 4 or 5 years), and ongoing chronic obstructive pulmonary disease (COPD) (has been severe for about 4 or 5 years). Concomitant medications included duloxetine taken for depression from an unspecified start date and ongoing (been taking this probably for 15 years); and arformoterol tartrate (BROVANA) (started taking this probably 5 years ago), budesonide (started taking this probably 5 years ago), tiotropium bromide (SPIRIVA) (has been taking this for probably about 4-5 years), oxygen (has been using this full time for 3 years), and Trilogy machine (she sleeps with this, it is an invasive intubation. She puts a big mask on and it pumps air in, pulls air out, letting her lungs rest. Her oxygen hooks up to it), all taken for emphysema and COPD from an unspecified start date and ongoing. The patient reported that she received the vaccine on 01Mar2021 and sometime in Apr2021 around Easter, she went to the hospital for COPD exacerbation, tiredness and weakness. The patient required a visit to the emergency room due to the events and reported that she went by ambulance to the hospital. The patient stated that she has these events often and it has nothing to do with the COVID vaccine. She went to the hospital with exacerbation of COPD and missed her date to get her last shot. She wanted to know whether she can get the 2nd dose of the vaccine with her experience after the 1st dose. The patient reported that she now weighs 177 after she has been pumped full of cortisone. The patient reported that her lung doctor was really the one that manages her medical. The patient reported that she thinks she came home from the hospital the day before Easter and she was in the hospital for 5 days (in Apr2021). She was sick before that, at home, and she finally had to call # to come and get her. She believes she had to call # the 5th day before Easter, but she was not positive. When asked to clarify what she meant by sick, the patient explained she was extremely tired, she couldn't get out of bed and couldn't move. She was having trouble breathing. She was on oxygen 24/7 and sleeps with a trilogy machine so she was having a lot of trouble, it was awful. She said she then found out at the hospital her red blood cell was below 5 and her iron was critically low. They had to give her 2 units of blood and an infusion. Then she went back yesterday and got another infusion and she has to go back next week for another infusion. The patient confirmed that she was hospitalized for COPD. She then stated she didn't know the exact date of when she was discharged from the hospital, but she was thinking it was the day she was scheduled for her second shot. She then clarified she came home Easter. The patient reported that she can't do much without having to sit down, catch her breath, and rest a little bit. She was improving but not as fast as she'd like to. While reading the vaccine record card, the patient stated "my eyes aren't as good as they used to be". Her pulmonologist stated she was going to die if she doesn't take the vaccine. If she catches COVID she was not going to make it, so her pulmonologist thinks her chances are better with the vaccine than without it. The patient said she goes all the time to the hospital; therefore, she doesn't think the events were related to the vaccine. She had been sick several times. They can't do anything about the bleeding, they can't go in to do anything because of her lungs, her lungs were so bad. No further details were provided regarding the bleeding she was speaking of. The patient reported that duloxetine doesn't come as 90 mg so she takes a 30 mg and 60 mg tablet; she mixes the Brovana and Budesoind and takes them at the same time, twice a day. She was given an albuterol solution, 0.5mg PRN (as needed), for her emphysema/COPD. She says she just started taking this from her last hospital stay. The patient reported that she did not remember her iron count, just that it was critically low. She did remember asking the nurse what could happen, and the nurse said a lot of things such as infection. She confirmed tests were done in regards to the lung cancer. Her lungs were too critical for any kind of invasive tests. It was reported that the events Exacerbation of COPD and "extremely tired, couldn't get out of bed, couldn't move" were assessed by the patient as unrelated to BNT162B2. The outcome of the events "Exacerbation of COPD/having trouble breathing" and " extremely tired, couldn't get out of bed, couldn't move/tiredness" was recovering, while the outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, the reported events Chronic Obstructive Pulmonary Disease, Fatigue, Asthenia, Blood iron decreased, Red blood cell count decreased and Asthenia are assessed as intercurrent medical conditions and unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
75 2021-04-17 cough, fatigue, sleepiness Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really so... Read more
Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really sore; Some choking; Anxiety; Cough during treatment; This is a solicited report (MARKETING PROGRAM NAME NOT AVAILABLE) based on the information received by Pfizer pharmacy. A contactable 75-year-old female consumer (patient)received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation; and treprostinil sodium, via inhalation from 12Feb2021 (Batch/Lot number was not reported) to an unspecified date and at 18-54 ug, 4x/day, via inhalation from an unspecified date (Batch/Lot number was not reported), at 36 ug, 4x/day for pulmonary arterial hypertension. Medical history included ongoing anxiety. The patient's concomitant medications were not reported. In Feb2021, the patient experienced event of cough during treatment. In 2021, the patient experienced event of gagging (retching). On 04Mar2021, the patient experienced event of anxiety; related it to going to the physician appointment. An additional dosage regimen of 36 ug (6 breaths), qid via IH route was added to Tyvaso. The patient reported that coughing (previously reported as cough) and gagging had improved after the treatment. The patient's current IH Tyvaso dose was 6 breaths four times a day. On 04 Mar 2021, 2 weeks 6 days after initiating IH Tyvaso, the patient had anxiety and related it to going to the physician appointment. The patient had reported ongoing anxiety since childhood. In 2021, the patient experienced the event of some choking. In 2021, the patient experienced the events of feels tired and sleepy all the time and arm was really sore (pain in extremity). The patient felt tired and sleepy all the time. Her arm was really sore and she was tired and sleepy. The outcome of the event cough and gagging was recovering while the outcome of the rest of the events was unknown. The action taken in response to treprostinil sodium for the events was unknown. An unspecified treatment was given to the patient for the event cough and gagging. The reporter assessed the causal relationship between the IH Tyvaso and the event of cough as possible. The reporter did not provide causality for the events of retching, choking, anxiety, fatigue, somnolence, and pain in extremity. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of choking,cough,gagging,and other events cannot be excluded but also contributory effect from other suspect drug TREPOSTINIL SODIUM. consider also possible contributory effects from patient's medical history and concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
75 2021-04-23 respiratory tract congestion, fever, lethargy, chills Fever; chills; chest and head congestion; chest and head congestion; lethargy; over all feeling of s... Read more
Fever; chills; chest and head congestion; chest and head congestion; lethargy; over all feeling of sick; This is a spontaneous report from a contactable consumer (reporting herself). A 75-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 03Feb2021 at 13:45 as a single dose for COVID-19 immunization. The patient did not received any other vaccines with 4 weeks prior to the COVID vaccine. The patient received metformin, metoprolol with in 2 weeks of COVID vaccination. The patient was allergic to ceclor, codeine. The patient medical history included diabetes, psoriatic, arthritis. On 04Feb2021 at 07:00, the patient experienced fever, chills, chest and head congestion, lethargy, over all feeling of sick. The patient received tylenol, musinex, bed rest, fluids as corrective treatment for the events. The outcome of the events was not recovered.